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Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401579
Recruitment Status : Completed
First Posted : May 26, 2020
Results First Posted : April 26, 2021
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Other: Placebo
Drug: Remdesivir
Drug: Baricitinib
Enrollment 1033
Recruitment Details Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 08May2020 and 01Jul2020.
Pre-assignment Details  
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet
Period Title: Overall Study
Started 515 518
Treated 507 509
Completed 431 408
Not Completed 84 110
Reason Not Completed
Death             23             36
Lost to Follow-up             40             41
Withdrawal by Subject             8             16
Physician Decision             1             2
Became ineligible after enrollment             1             1
Enrolled but treatment not administered             7             9
Adverse Event             2             1
Scheduling error             1             2
Transferred to another hospital             1             2
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo Total
Hide Arm/Group Description 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course. Total of all reporting groups
Overall Number of Baseline Participants 515 518 1033
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 518 participants 1033 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
368
  71.5%
360
  69.5%
728
  70.5%
>=65 years
147
  28.5%
158
  30.5%
305
  29.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 515 participants 518 participants 1033 participants
55.0  (15.4) 55.8  (16.0) 55.4  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 518 participants 1033 participants
Female
196
  38.1%
185
  35.7%
381
  36.9%
Male
319
  61.9%
333
  64.3%
652
  63.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 518 participants 1033 participants
Hispanic or Latino
263
  51.1%
268
  51.7%
531
  51.4%
Not Hispanic or Latino
246
  47.8%
240
  46.3%
486
  47.0%
Unknown or Not Reported
6
   1.2%
10
   1.9%
16
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 518 participants 1033 participants
American Indian or Alaska Native
2
   0.4%
8
   1.5%
10
   1.0%
Asian
49
   9.5%
52
  10.0%
101
   9.8%
Native Hawaiian or Other Pacific Islander
4
   0.8%
7
   1.4%
11
   1.1%
Black or African American
77
  15.0%
79
  15.3%
156
  15.1%
White
251
  48.7%
245
  47.3%
496
  48.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
132
  25.6%
127
  24.5%
259
  25.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 515 participants 518 participants 1033 participants
South Korea
11
   2.1%
11
   2.1%
22
   2.1%
Singapore
22
   4.3%
22
   4.2%
44
   4.3%
United States
441
  85.6%
444
  85.7%
885
  85.7%
Japan
0
   0.0%
1
   0.2%
1
   0.1%
Denmark
4
   0.8%
5
   1.0%
9
   0.9%
Mexico
35
   6.8%
33
   6.4%
68
   6.6%
United Kingdom
0
   0.0%
1
   0.2%
1
   0.1%
Spain
2
   0.4%
1
   0.2%
3
   0.3%
Disease severity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 518 participants 1033 participants
Severe Disease Severity
176
  34.2%
191
  36.9%
367
  35.5%
Moderate Disease Severity
339
  65.8%
327
  63.1%
666
  64.5%
[1]
Measure Description:

Severe disease was defined as hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive or non-invasive ventilation, or high flow oxygen Moderate disease was defined as hospitalized, requiring supplemental oxygen or not requiring supplemental oxygen.

Disease severity was as defined at the time or randomization.
1.Primary Outcome
Title Time to Recovery
Hide Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (95% Confidence Interval)
Unit of Measure: Days
7.0
(6.0 to 8.0)
8.0
(7.0 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
1.00 to 1.31
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to Recovery by Race
Hide Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (95% Confidence Interval)
Unit of Measure: Days
Asian Number Analyzed 49 participants 52 participants
10
(7.0 to 13.0)
10.0
(9.0 to 13.0)
Black or African American Number Analyzed 77 participants 79 participants
7.0
(5.0 to 8.0)
6.0
(5.0 to 8.0)
White Number Analyzed 251 participants 245 participants
7.0
(5.0 to 8.0)
7.0
(6.0 to 9.0)
Other Number Analyzed 138 participants 142 participants
7.0
(6.0 to 8.0)
8.0
(6.0 to 11.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Asian participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.73 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Black or African American participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.75 to 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for White participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.93 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Race of Other participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
1.03 to 1.74
Estimation Comments [Not Specified]
3.Primary Outcome
Title Time to Recovery by Ethnicity
Hide Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized and for whom ethnicity was reported
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 509 508
Median (95% Confidence Interval)
Unit of Measure: Days
Not Hispanic or Latino Number Analyzed 246 participants 240 participants
7.0
(6.0 to 8.0)
9.0
(7.0 to 10.0)
Hispanic or Latino Number Analyzed 263 participants 268 participants
7.0
(6.0 to 8.0)
7.0
(6.0 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Not Hispanic or Latino participants
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.08 to 1.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Hispanic or Latino participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.89 to 1.31
Estimation Comments [Not Specified]
4.Primary Outcome
Title Time to Recovery by Sex
Hide Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (95% Confidence Interval)
Unit of Measure: Days
Male Number Analyzed 319 participants 333 participants
7.0
(6.0 to 8.0)
9.0
(7.0 to 11.0)
Female Number Analyzed 196 participants 185 participants
7.0
(6.0 to 8.0)
7.0
(6.0 to 7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Male participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.04 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments This analysis is for Female participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.85 to 1.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Alanine Transaminase (ALT)
Hide Description Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 491 491
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3 Number Analyzed 491 participants 491 participants
3.3  (37.1) 2.0  (30.1)
Day 5 Number Analyzed 407 participants 406 participants
16.8  (104.4) 8.8  (40.9)
Day 8 Number Analyzed 268 participants 284 participants
7.9  (45.2) 7.8  (46.9)
Day 11 Number Analyzed 187 participants 201 participants
0.0  (37.5) 7.3  (70.2)
Day 15 Number Analyzed 250 participants 270 participants
5.0  (61.5) 3.9  (55.1)
Day 29 Number Analyzed 256 participants 255 participants
-5.4  (43.0) 2.3  (116.1)
6.Secondary Outcome
Title Change From Baseline in Aspartate Transaminase (AST)
Hide Description Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 486 487
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3 Number Analyzed 486 participants 487 participants
3.1  (72.4) 2.4  (126.4)
Day 5 Number Analyzed 404 participants 403 participants
27.4  (413.1) 2.8  (48.3)
Day 8 Number Analyzed 265 participants 282 participants
-5.6  (38.4) -4.3  (42.3)
Day 11 Number Analyzed 185 participants 200 participants
-10.6  (46.4) 6.4  (208.3)
Day 15 Number Analyzed 246 participants 266 participants
-6.0  (110.1) -3.9  (91.0)
Day 29 Number Analyzed 251 participants 251 participants
-17.1  (46.7) 2.4  (291.1)
7.Secondary Outcome
Title Change From Baseline in Creatinine
Hide Description Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 494 495
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter (mg/dL)
Day 3 Number Analyzed 494 participants 495 participants
-0.036  (0.465) -0.019  (0.362)
Day 5 Number Analyzed 412 participants 410 participants
-0.078  (0.475) 0.001  (0.556)
Day 8 Number Analyzed 270 participants 285 participants
-0.082  (0.570) 0.129  (0.958)
Day 11 Number Analyzed 190 participants 202 participants
-0.055  (0.798) 0.194  (1.037)
Day 15 Number Analyzed 254 participants 273 participants
-0.042  (0.714) 0.094  (0.662)
Day 29 Number Analyzed 260 participants 257 participants
-0.034  (0.678) 0.033  (0.511)
8.Secondary Outcome
Title Change From Baseline in Glucose
Hide Description Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 493 493
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3 Number Analyzed 493 participants 493 participants
-17.1  (56.4) -6.0  (54.0)
Day 5 Number Analyzed 412 participants 409 participants
-15.9  (59.7) -1.6  (58.4)
Day 8 Number Analyzed 270 participants 284 participants
-16.8  (78.9) 5.0  (73.7)
Day 11 Number Analyzed 190 participants 203 participants
-8.1  (72.3) 1.2  (66.2)
Day 15 Number Analyzed 252 participants 271 participants
-11.1  (69.8) 0.8  (68.3)
Day 29 Number Analyzed 257 participants 256 participants
-4.6  (66.5) -2.2  (60.3)
9.Secondary Outcome
Title Change From Baseline in Hemoglobin
Hide Description Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 493 494
Mean (Standard Deviation)
Unit of Measure: grams/deciliter (g/dL)
Day 3 Number Analyzed 493 participants 494 participants
-0.46  (1.05) -0.34  (1.51)
Day 5 Number Analyzed 410 participants 409 participants
-0.62  (1.23) -0.64  (1.13)
Day 8 Number Analyzed 270 participants 284 participants
-0.93  (1.61) -1.08  (1.47)
Day 11 Number Analyzed 189 participants 199 participants
-1.29  (1.85) -1.62  (1.88)
Day 15 Number Analyzed 253 participants 267 participants
-0.96  (1.87) -1.12  (2.38)
Day 29 Number Analyzed 260 participants 254 participants
-0.54  (1.87) -0.77  (2.25)
10.Secondary Outcome
Title Change From Baseline in Platelets
Hide Description Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 493 494
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 493 participants 494 participants
55.9  (54.0) 52.6  (51.6)
Day 5 Number Analyzed 410 participants 409 participants
116.6  (87.8) 106.1  (86.9)
Day 8 Number Analyzed 269 participants 284 participants
197.9  (137.4) 158.9  (128.5)
Day 11 Number Analyzed 189 participants 199 participants
229.9  (156.0) 145.7  (146.4)
Day 15 Number Analyzed 252 participants 267 participants
175.9  (158.8) 111.6  (134.9)
Day 29 Number Analyzed 260 participants 254 participants
16.5  (95.8) 36.9  (107.9)
11.Secondary Outcome
Title Change From Baseline in Prothrombin International Normalized Ratio (INR)
Hide Description Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 447 439
Mean (Standard Deviation)
Unit of Measure: ratio
Day 3 Number Analyzed 447 participants 439 participants
-0.03  (1.13) 0.05  (0.59)
Day 5 Number Analyzed 360 participants 370 participants
0.02  (1.25) 0.08  (0.65)
Day 8 Number Analyzed 244 participants 250 participants
0.01  (0.96) 0.08  (0.98)
Day 11 Number Analyzed 162 participants 175 participants
0.04  (0.65) 0.03  (1.04)
Day 15 Number Analyzed 222 participants 241 participants
-0.04  (0.25) -0.08  (0.91)
Day 29 Number Analyzed 232 participants 232 participants
-0.12  (0.55) -0.03  (0.99)
12.Secondary Outcome
Title Change From Baseline in Total Bilirubin
Hide Description Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 490 491
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3 Number Analyzed 490 participants 491 participants
-0.06  (0.32) -0.01  (0.43)
Day 5 Number Analyzed 407 participants 405 participants
-0.04  (0.37) 0.01  (0.42)
Day 8 Number Analyzed 268 participants 284 participants
-0.06  (0.41) 0.01  (0.66)
Day 11 Number Analyzed 187 participants 201 participants
-0.08  (0.43) 0.08  (1.19)
Day 15 Number Analyzed 250 participants 270 participants
-0.10  (0.37) 0.08  (1.20)
Day 29 Number Analyzed 256 participants 254 participants
-0.10  (0.36) 0.01  (0.91)
13.Secondary Outcome
Title Change From Baseline in White Blood Cell Count (WBC)
Hide Description Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 493 494
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 493 participants 494 participants
-0.831  (3.020) -0.037  (2.588)
Day 5 Number Analyzed 410 participants 409 participants
-0.276  (3.399) 0.392  (3.238)
Day 8 Number Analyzed 270 participants 284 participants
0.663  (4.006) 1.606  (4.536)
Day 11 Number Analyzed 189 participants 199 participants
1.869  (5.683) 2.938  (5.419)
Day 15 Number Analyzed 253 participants 267 participants
0.694  (5.125) 2.162  (5.741)
Day 29 Number Analyzed 260 participants 254 participants
-0.364  (4.532) 0.712  (4.176)
14.Secondary Outcome
Title Change From Baseline in Neutrophils
Hide Description BBlood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 488 493
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 488 participants 493 participants
-1.925  (6.234) -0.333  (2.787)
Day 5 Number Analyzed 408 participants 404 participants
-1.334  (8.092) -0.204  (3.630)
Day 8 Number Analyzed 268 participants 282 participants
-0.813  (9.695) 1.139  (6.665)
Day 11 Number Analyzed 186 participants 196 participants
-0.046  (8.881) 1.847  (5.152)
Day 15 Number Analyzed 249 participants 267 participants
-1.192  (7.844) 1.414  (7.995)
Day 29 Number Analyzed 257 participants 253 participants
-1.708  (6.735) -0.656  (4.205)
15.Secondary Outcome
Title Change From Baseline in Lymphocytes
Hide Description Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 488 493
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 488 participants 493 participants
0.503  (2.290) 0.074  (3.844)
Day 5 Number Analyzed 408 participants 404 participants
0.620  (2.540) 0.205  (3.838)
Day 8 Number Analyzed 268 participants 282 participants
0.515  (2.094) 0.304  (1.366)
Day 11 Number Analyzed 186 participants 196 participants
0.541  (1.204) 0.409  (0.709)
Day 15 Number Analyzed 249 participants 267 participants
0.687  (1.579) 0.718  (1.684)
Day 29 Number Analyzed 257 participants 253 participants
0.653  (1.293) 0.927  (1.996)
16.Secondary Outcome
Title Change From Baseline in Monocytes
Hide Description Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 487 493
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 487 participants 493 participants
0.004  (0.810) 0.062  (0.750)
Day 5 Number Analyzed 408 participants 404 participants
0.094  (1.053) 0.153  (1.013)
Day 8 Number Analyzed 268 participants 282 participants
0.105  (0.948) 0.279  (0.758)
Day 11 Number Analyzed 186 participants 196 participants
0.210  (0.439) 0.378  (0.512)
Day 15 Number Analyzed 249 participants 267 participants
0.256  (0.591) 0.329  (0.606)
Day 29 Number Analyzed 257 participants 253 participants
0.108  (0.434) 0.212  (0.745)
17.Secondary Outcome
Title Change From Baseline in Basophils
Hide Description Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 483 492
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 483 participants 492 participants
0.000  (0.039) 0.001  (0.050)
Day 5 Number Analyzed 402 participants 402 participants
0.007  (0.070) 0.006  (0.044)
Day 8 Number Analyzed 265 participants 281 participants
0.011  (0.055) 0.017  (0.075)
Day 11 Number Analyzed 185 participants 195 participants
0.014  (0.063) 0.022  (0.063)
Day 15 Number Analyzed 247 participants 265 participants
0.026  (0.085) 0.037  (0.104)
Day 29 Number Analyzed 257 participants 250 participants
0.022  (0.045) 0.036  (0.092)
18.Secondary Outcome
Title Change From Baseline in Eosinophils
Hide Description Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 484 492
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3 Number Analyzed 484 participants 492 participants
0.050  (0.135) 0.039  (0.201)
Day 5 Number Analyzed 405 participants 403 participants
0.104  (0.402) 0.075  (0.257)
Day 8 Number Analyzed 265 participants 281 participants
0.088  (0.126) 0.086  (0.232)
Day 11 Number Analyzed 185 participants 195 participants
0.078  (0.119) 0.115  (0.299)
Day 15 Number Analyzed 247 participants 264 participants
0.121  (0.231) 0.109  (0.163)
Day 29 Number Analyzed 257 participants 251 participants
0.192  (0.171) 0.205  (0.267)
19.Secondary Outcome
Title Change in National Early Warning Score (NEWS) From Baseline
Hide Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
Time Frame Days 1, 3, 5, 8, 11, 15, 22, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 -0.5  (2.5) -0.1  (2.6)
Day 5 -0.9  (2.8) -0.4  (2.8)
Day 8 -1.5  (2.9) -0.8  (3.3)
Day 11 -1.8  (3.2) -1.1  (3.5)
Day 15 -2.1  (3.3) -1.2  (3.9)
Day 22 -2.0  (3.8) -1.2  (4.6)
Day 29 -2.2  (4.3) -1.4  (5.0)
20.Secondary Outcome
Title Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Hide Description Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 507 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.8
(36.5 to 45.3)
46.8
(42.4 to 51.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -6
Confidence Interval (2-Sided) 95%
-12 to 0
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants Reporting Serious Adverse Events (SAEs)
Hide Description An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 507 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.0
(12.9 to 19.5)
21.0
(17.6 to 24.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5
Confidence Interval (2-Sided) 95%
-10 to 0
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Duration of Hospitalization
Hide Description Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputation for participants who died Number Analyzed 515 participants 518 participants
8
(5 to 15)
8
(5 to 20)
Restricted to participants who did not die Number Analyzed 491 participants 481 participants
8
(5 to 13)
8
(5 to 15)
23.Secondary Outcome
Title Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Hide Description Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 70 82
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 70 participants 82 participants
6
(3 to 15)
4.5
(2 to 11)
Among participants who did not die Number Analyzed 65 participants 72 participants
5
(3 to 10)
4
(2 to 7)
24.Secondary Outcome
Title Duration of New Oxygen Use
Hide Description Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 16 29
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died
3
(2 to 4)
3
(2 to 6)
Among participants who did not die
3
(2 to 4)
3
(2 to 6)
25.Secondary Outcome
Title Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Hide Description Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 46 70
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 46 participants 70 participants
16
(8 to 28)
27
(12 to 28)
Among participants who did not die Number Analyzed 39 participants 52 participants
13
(6 to 22)
20
(10 to 27)
26.Secondary Outcome
Title Duration of Oxygen Use
Hide Description Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants who were on oxygen at baseline.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 445 446
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died Number Analyzed 445 participants 446 participants
10
(4 to 27)
12
(4 to 28)
Among participants who did not die Number Analyzed 421 participants 409 participants
9
(4 to 24)
10
(4 to 28)
27.Secondary Outcome
Title Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Hide Description Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
Time Frame Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Received less than 10 Infusions of Remdesivir due to Discharge
55
(50 to 59)
51
(47 to 55)
Received less than 10 Infusions of Remdesivir due to Death
0
(0 to 1)
1
(0 to 2)
Received less than 14 doses of Baricitinib/Placebo due to Discharge
66
(62 to 70)
59
(55 to 64)
Received less than 14 doses of Baricitinib/Placebo due to Death
0
(0 to 1)
1
(1 to 3)
Had Any Infusions of Remdesivir Halted or Slowed
2
(1 to 4)
2
(1 to 3)
Had Any Oral Doses of Baricitinib/Placebo Modified
16
(13 to 20)
18
(14 to 21)
Missed Any Maintenance Dose of Remdesivir
23
(20 to 27)
27
(23 to 31)
Missed Any Oral Dose of Baricitinib/Placebo
30
(26 to 34)
34
(30 to 38)
Terminated Early Prior to Completing 10 Infusions of Remdesivir
3
(2 to 5)
4
(3 to 6)
Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo
4
(2 to 6)
5
(3 to 7)
28.Secondary Outcome
Title Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Hide Description The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 461 461
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10
(8 to 13)
15
(12 to 19)
29.Secondary Outcome
Title Percentage of Participants Requiring New Oxygen Use
Hide Description The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to randomized participants not requiring oxygen at baseline.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 70 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(15 to 34)
40
(30 to 52)
30.Secondary Outcome
Title Mean Change in the Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
Time Frame Day 1, 3, 5, 8, 11, 15, 22, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3 0.1  (0.5) 0.1  (0.6)
Day 5 0.0  (0.7) 0.0  (0.7)
Day 8 -0.3  (0.9) -0.1  (0.9)
Day 11 -0.4  (1.0) -0.2  (1.0)
Day 15 -2.3  (1.9) -1.9  (2.0)
Day 22 -2.7  (1.9) -2.3  (2.1)
Day 29 -2.9  (1.9) -2.5  (2.1)
31.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study visit
2
(1 to 4)
3
(2 to 5)
Hospitalized, on invasive mech. vent. or ECMO
9
(7 to 12)
16
(13 to 19)
Hospitalized, on non-invasive vent./high flow O2
4
(3 to 6)
4
(2 to 6)
Hospitalized, requiring supplemental oxygen
8
(6 to 11)
10
(7 to 13)
Hospitalized, not on O2, requiring ongoing care
6
(4 to 8)
3
(2 to 5)
Hospitalized, not requiring O2, no longer req care
2
(1 to 3)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
34
(30 to 39)
31
(28 to 36)
Not hospitalized, no limitations on activities
34
(30 to 39)
32
(28 to 36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
1.01 to 1.57
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
0
(0 to 1)
0
(0 to 1)
Hospitalized, on invasive mech. vent. or ECMO
10
(8 to 13)
11
(9 to 14)
Hospitalized, on non-invasive vent./high flow O2
20
(17 to 24)
22
(18 to 26)
Hospitalized, requiring supplemental oxygen
56
(52 to 60)
53
(49 to 58)
Hospitalized, not on O2, requiring ongoing care
14
(11 to 17)
14
(11 to 17)
Hospitalized, not requiring O2, no longer req care
0
(0 to 1)
0
(0 to 1)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discontinued
0
(0 to 1)
0
(0 to 1)
33.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
0.4
(0 to 1)
0
(0 to 1)
Hospitalized, on invasive mech. vent. or ECMO
15
(12 to 18)
16
(13 to 20)
Hospitalized, on non-invasive vent./high flow O2
22
(18 to 25)
22
(18 to 25)
Hospitalized, requiring supplemental oxygen
45
(41 to 50)
44
(40 to 49)
Hospitalized, not on O2, requiring ongoing care
16
(13 to 20)
14
(12 to 18)
Hospitalized, not requiring O2, no longer req care
0.2
(0 to 1)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
0.2
(0 to 1)
0.4
(0 to 1)
No clinical status score reported - Discontinued
1
(1 to 3)
2
(1 to 4)
34.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
1
(0 to 2)
0
(0 to 1)
Hospitalized, on invasive mech. vent. or ECMO
15
(12 to 19)
18
(15 to 21)
Hospitalized, on non-invasive vent./high flow O2
17
(14 to 20)
18
(15 to 22)
Hospitalized, requiring supplemental oxygen
35
(31 to 39)
33
(29 to 37)
Hospitalized, not on O2, requiring ongoing care
19
(16 to 22)
15
(12 to 18)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
0.2
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0.2
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0.2
(0 to 1)
No clinical status score reported - Discharged
10
(8 to 13)
13
(10 to 16)
No clinical status score reported - Discontinued
2
(1 to 4)
3
(2 to 5)
35.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
1
(0 to 2)
1
(0 to 2)
Hospitalized, on invasive mech. vent. or ECMO
13
(11 to 17)
18
(15 to 22)
Hospitalized, on non-invasive vent./high flow O2
11
(8 to 14)
12
(9 to 15)
Hospitalized, requiring supplemental oxygen
18
(15 to 22)
18
(15 to 22)
Hospitalized, not on O2, requiring ongoing care
12
(10 to 16)
10
(7 to 13)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
0.2
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0.4
(0 to 1)
0
(0 to 1)
No clinical status score reported - Hospitalized
0
(0 to 1)
0.4
(0 to 1)
No clinical status score reported - Discharged
40
(35 to 44)
36
(32 to 41)
No clinical status score reported - Discontinued
3
(2 to 5)
4
(3 to 6)
36.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
1
(0 to 2)
2
(1 to 4)
Hospitalized, on invasive mech. vent. or ECMO
11
(9 to 14)
16
(13 to 20)
Hospitalized, on non-invasive vent./high flow O2
6
(5 to 9)
7
(5 to 9)
Hospitalized, requiring supplemental oxygen
12
(10 to 15)
10
(8 to 13)
Hospitalized, not on O2, requiring ongoing care
9
(6 to 11)
7
(5 to 9)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
1
(0 to 2)
Not hospitalized, limit on activities/req home O2
0
(0 to 1)
0
(0 to 1)
Not hospitalized, no limitations on activities
0.2
(0 to 1)
0.2
(0 to 2)
No clinical status score reported - Hospitalized
0
(0 to 1)
1
(0 to 2)
No clinical status score reported - Discharged
56
(52 to 60)
52
(48 to 56)
No clinical status score reported - Discontinued
3
(2 to 5)
4
(3 to 6)
37.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
4
(3 to 6)
6
(5 to 9)
Hospitalized, on invasive mech. vent. or ECMO
6
(4 to 8)
9
(7 to 12)
Hospitalized, on non-invasive vent./high flow O2
3
(2 to 5)
1
(1 to 3)
Hospitalized, requiring supplemental oxygen
3
(2 to 5)
5
(3 to 7)
Hospitalized, not on O2, requiring ongoing care
2
(1 to 4)
3
(1 to 4)
Hospitalized, not requiring O2, no longer req care
1
(1 to 3)
0.4
(0 to 1)
Not hospitalized, limit on activities/req home O2
24
(21 to 28)
25
(21 to 29)
Not hospitalized, no limitations on activities
44
(40 to 49)
37
(33 to 42)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
4
(2 to 6)
3
(2 to 5)
No clinical status score reported - Discontinued
9
(6 to 11)
10
(8 to 13)
38.Secondary Outcome
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
5
(3 to 7)
7
(5 to 10)
Hospitalized, on invasive mech. vent. or ECMO
3
(2 to 5)
7
(5 to 9)
Hospitalized, on non-invasive vent./high flow O2
2
(1 to 3)
1
(1 to 3)
Hospitalized, requiring supplemental oxygen
2
(1 to 4)
3
(2 to 5)
Hospitalized, not on O2, requiring ongoing care
3
(2 to 5)
1
(0 to 2)
Hospitalized, not requiring O2, no longer req care
1
(0 to 2)
0.2
(0 to 1)
Not hospitalized, limit on activities/req home O2
23
(20 to 27)
23
(20 to 27)
Not hospitalized, no limitations on activities
49
(44 to 53)
43
(39 to 47)
No clinical status score reported - Hospitalized
0
(0 to 1)
0
(0 to 1)
No clinical status score reported - Discharged
0.4
(0 to 1)
1
(1 to 3)
No clinical status score reported - Discontinued
12
(9 to 15)
13
(10 to 16)
No clinical status, completed study without reporting score
0.2
(0 to 1)
0.2
(0 to 1)
39.Secondary Outcome
Title 14-day Participant Mortality
Hide Description The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
Time Frame Day 1 through Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consists of all participants as randomized.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.02
(0.01 to 0.03)
0.03
(0.02 to 0.05)
40.Secondary Outcome
Title 28-day Participant Mortality
Hide Description The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.05
(0.03 to 0.08)
0.08
(0.06 to 0.11)
41.Secondary Outcome
Title Time to an Improvement of One Category Using an Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (95% Confidence Interval)
Unit of Measure: Days
6.0
(5.0 to 7.0)
8.0
(7.0 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
1.06 to 1.39
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Time to an Improvement of Two Categories Using an Ordinal Scale
Hide Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes all participants as randomized
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 515 518
Median (95% Confidence Interval)
Unit of Measure: Days
12.0
(12.0 to 13.0)
13.0 [1] 
(NA to NA)
[1]
Due to a large number of subjects improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
1.05 to 1.38
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
Hide Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Time Frame Day 1 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population includes participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 361 334
Median (95% Confidence Interval)
Unit of Measure: Days
6.0
(6.0 to 7.0)
7.0
(6.0 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remdesivir Plus Baricitinib, Remdesivir Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.07 to 1.44
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP)
Hide Description Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 446 455
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 3 Number Analyzed 446 participants 455 participants
-23.035  (169.442) -18.671  (102.661)
Day 5 Number Analyzed 368 participants 367 participants
-58.935  (110.364) -30.908  (150.076)
Day 8 Number Analyzed 241 participants 250 participants
-78.411  (104.943) -62.038  (125.254)
Day 11 Number Analyzed 159 participants 181 participants
-103.789  (124.751) -88.881  (159.184)
Day 15 Number Analyzed 221 participants 240 participants
-122.339  (110.502) -112.588  (155.762)
Day 29 Number Analyzed 217 participants 219 participants
-131.333  (115.243) -122.342  (268.733)
45.Secondary Outcome
Title Change From Baseline in D-dimer Concentration
Hide Description Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Overall Number of Participants Analyzed 436 432
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 3 Number Analyzed 436 participants 432 participants
-0.374  (7.062) 0.384  (5.663)
Day 5 Number Analyzed 352 participants 347 participants
0.053  (10.968) -0.149  (5.978)
Day 8 Number Analyzed 227 participants 230 participants
-0.271  (9.994) 0.351  (5.387)
Day 11 Number Analyzed 153 participants 160 participants
0.622  (12.779) 0.309  (7.283)
Day 15 Number Analyzed 215 participants 230 participants
-0.988  (11.352) -0.422  (6.579)
Day 29 Number Analyzed 223 participants 206 participants
0.774  (27.229) -0.219  (10.386)
Time Frame Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Adverse Event Reporting Description Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
 
Arm/Group Title Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Hide Arm/Group Description 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
All-Cause Mortality
Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   24/515 (4.66%)      37/518 (7.14%)    
Hide Serious Adverse Events
Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/507 (17.36%)      109/509 (21.41%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/507 (0.20%)  1 2/509 (0.39%)  2
Leukopenia * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Sickle cell anaemia with crisis * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Lymphopenia * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Cardiac disorders     
Cardiac arrest * 1  2/507 (0.39%)  2 3/509 (0.59%)  3
Pulseless electrical activity * 1  2/507 (0.39%)  2 1/509 (0.20%)  1
Cardio-respiratory arrest * 1  1/507 (0.20%)  1 1/509 (0.20%)  1
Cardiac failure * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Sinus tachycardia * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Aortic valve stenosis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Arrhythmia * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Atrial fibrillation * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Atrioventricular block * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Bradycardia * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Left ventricular failure * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Right ventricular dysfunction * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Eye disorders     
Visual impairment * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrhage * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Abdominal pain * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
General disorders     
Multiple organ dysfunction syndrome * 1  2/507 (0.39%)  2 6/509 (1.18%)  6
Chest pain * 1  2/507 (0.39%)  2 0/509 (0.00%)  0
Asthenia * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Non-cardiac chest pain * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Injection site induration * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Oedema peripheral * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Hepatobiliary disorders     
Hepatic haemorrhage * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Hepatitis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Immune system disorders     
Hypersensitivity * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Infections and infestations     
Septic shock * 1  4/507 (0.79%)  4 8/509 (1.57%)  8
Pneumonia * 1  2/507 (0.39%)  2 8/509 (1.57%)  8
Sepsis * 1  2/507 (0.39%)  2 5/509 (0.98%)  5
Intervertebral discitis * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Lower respiratory tract infection * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Prostatic abscess * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Urinary tract infection * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Aspergillus infection * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Lung abscess * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Urosepsis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Injury, poisoning and procedural complications     
Procedural hypotension * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Endotracheal intubation complication * 1  0/507 (0.00%)  0 1/509 (0.20%)  2
Fall * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Overdose * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Subdural haematoma * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Investigations     
Alanine aminotransferase increased * 1  0/507 (0.00%)  0 3/509 (0.59%)  3
Aspartate aminotransferase increased * 1  0/507 (0.00%)  0 2/509 (0.39%)  2
Lymphocyte count decreased * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Blood creatinine increased * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Blood glucose decreased * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Haemoglobin decreased * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Troponin increased * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Acidosis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Diabetic ketoacidosis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Hyperkalaemia * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Hypoglycaemia * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Metabolic acidosis * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Musculoskeletal and connective tissue disorders     
Haematoma muscle * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lipoma * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  1/507 (0.20%)  1 2/509 (0.39%)  2
Encephalopathy * 1  1/507 (0.20%)  1 2/509 (0.39%)  2
Guillain-Barre syndrome * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Nervous system disorder * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Haemorrhage intracranial * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Presyncope * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Renal and urinary disorders     
Acute kidney injury * 1  5/507 (0.99%)  5 11/509 (2.16%)  11
Renal failure * 1  0/507 (0.00%)  0 5/509 (0.98%)  5
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  29/507 (5.72%)  30 37/509 (7.27%)  38
Acute respiratory failure * 1  18/507 (3.55%)  18 16/509 (3.14%)  16
Acute respiratory distress syndrome * 1  4/507 (0.79%)  4 10/509 (1.96%)  10
Respiratory distress * 1  7/507 (1.38%)  8 7/509 (1.38%)  7
Pulmonary embolism * 1  5/507 (0.99%)  5 1/509 (0.20%)  1
Hypoxia * 1  3/507 (0.59%)  3 3/509 (0.59%)  4
Dyspnoea * 1  2/507 (0.39%)  2 4/509 (0.79%)  4
Pneumothorax * 1  1/507 (0.20%)  1 4/509 (0.79%)  4
Respiratory arrest * 1  1/507 (0.20%)  1 1/509 (0.20%)  1
Pneumonia aspiration * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Pneumomediastinum * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
Tachypnoea * 1  0/507 (0.00%)  0 2/509 (0.39%)  2
Vascular disorders     
Hypotension * 1  6/507 (1.18%)  6 5/509 (0.98%)  5
Shock * 1  2/507 (0.39%)  2 4/509 (0.79%)  4
Deep vein thrombosis * 1  1/507 (0.20%)  1 1/509 (0.20%)  1
Distributive shock * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Thrombophlebitis * 1  1/507 (0.20%)  1 0/509 (0.00%)  0
Embolism venous * 1  0/507 (0.00%)  0 1/509 (0.20%)  1
1
Term from vocabulary, MedDRA (23.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remdesivir Plus Baricitinib Remdesivir Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   147/507 (28.99%)      164/509 (32.22%)    
Blood and lymphatic system disorders     
Anaemia * 1  25/507 (4.93%)  28 31/509 (6.09%)  40
Investigations     
Glomerular filtration rate decreased * 1  50/507 (9.86%)  52 45/509 (8.84%)  46
Haemoglobin decreased * 1  30/507 (5.92%)  32 31/509 (6.09%)  32
Lymphocyte count decreased * 1  25/507 (4.93%)  28 36/509 (7.07%)  36
Blood glucose increased * 1  26/507 (5.13%)  26 28/509 (5.50%)  28
Metabolism and nutrition disorders     
Hyperglycaemia * 1  29/507 (5.72%)  34 40/509 (7.86%)  47
Renal and urinary disorders     
Acute kidney injury * 1  16/507 (3.16%)  17 27/509 (5.30%)  28
1
Term from vocabulary, MedDRA (23.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: John Beigel, MD
Organization: NIAID
Phone: 3014519881
EMail: jbeigel@niaid.nih.gov
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh MD, Kim ES, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie MC, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH; ACTT-2 Study Group Members. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795-807. doi: 10.1056/NEJMoa2031994. Epub 2020 Dec 11.
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04401579    
Other Study ID Numbers: 20-0006 ACTT-2
First Submitted: May 22, 2020
First Posted: May 26, 2020
Results First Submitted: February 25, 2021
Results First Posted: April 26, 2021
Last Update Posted: March 14, 2022