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Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

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: NCT04709835
Recruitment Status : Completed
First Posted : January 14, 2021
Results First Posted : October 13, 2022
Last Update Posted : October 26, 2022
Sponsor:
Collaborator:
Atea Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: AT-527
Drug: Placebo
Enrollment 104
Recruitment Details Participants were enrolled in the study at sites in the United Kingdom, Spain, Greece, Latvia, Ireland and Canada.
Pre-assignment Details The study enrolled non-hospitalized adult participants with mild or moderate COVID-19. Four enrolled participants were not treated and are not included in the Results.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5. Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5. Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Period Title: Overall Study
Started 40 30 30
Completed 40 29 30
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg) Total
Hide Arm/Group Description Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5. Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5. Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5. Total of all reporting groups
Overall Number of Baseline Participants 40 30 30 100
Hide Baseline Analysis Population Description
The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 30 participants 30 participants 100 participants
36.8  (13.2) 32.7  (10.9) 40.3  (15.6) 36.6  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 30 participants 100 participants
Female
22
  55.0%
15
  50.0%
17
  56.7%
54
  54.0%
Male
18
  45.0%
15
  50.0%
13
  43.3%
46
  46.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 30 participants 100 participants
Hispanic or Latino
3
   7.5%
4
  13.3%
1
   3.3%
8
   8.0%
Not Hispanic or Latino
36
  90.0%
26
  86.7%
29
  96.7%
91
  91.0%
Unknown or Not Reported
1
   2.5%
0
   0.0%
0
   0.0%
1
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 30 participants 100 participants
American Indian or Alaska Native
0
   0.0%
1
   3.3%
0
   0.0%
1
   1.0%
Asian
0
   0.0%
0
   0.0%
1
   3.3%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.0%
0
   0.0%
1
   3.3%
3
   3.0%
White
38
  95.0%
29
  96.7%
28
  93.3%
95
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 40 participants 30 participants 30 participants 100 participants
6.24  (1.40) 6.98  (1.10) 5.94  (1.46) 6.37  (1.39)
[1]
Measure Description: SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR).
1.Primary Outcome
Title Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 550 mg and Matched Placebo
Hide Description SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.
Time Frame Baseline, Day 3, Day 5, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Placebo Matched to AT-527 550 mg AT-527 550 mg (1x550 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: log10 copies/mL
Day 3 Number Analyzed 30 participants 29 participants
-1.16  (0.203) -1.26  (0.206)
Day 5 Number Analyzed 29 participants 30 participants
-2.42  (0.230) -2.11  (0.226)
Day 7 Number Analyzed 29 participants 29 participants
-3.13  (0.220) -3.38  (0.220)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Matched to AT-527 550 mg, AT-527 550 mg (1x550 mg)
Comments Day 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7144
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.11
Confidence Interval (2-Sided) 80%
-0.49 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.292
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Matched to AT-527 550 mg, AT-527 550 mg (1x550 mg)
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3373
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.32
Confidence Interval (2-Sided) 80%
-0.11 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.327
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Matched to AT-527 550 mg, AT-527 550 mg (1x550 mg)
Comments Day 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4260
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.25
Confidence Interval (2-Sided) 80%
-0.66 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.315
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
2.Primary Outcome
Title Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 1100 mg and Pooled Placebo
Hide Description SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.
Time Frame Baseline, Day 3, Day 5, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30
Mean (Standard Error)
Unit of Measure: log10 copies/mL
Day 3 Number Analyzed 40 participants 29 participants
-1.08  (0.190) -1.18  (0.223)
Day 5 Number Analyzed 38 participants 30 participants
-2.21  (0.205) -2.31  (0.231)
Day 7 Number Analyzed 39 participants 30 participants
-2.70  (0.207) -2.78  (0.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7351
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.10
Confidence Interval (2-Sided) 80%
-0.48 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.294
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7524
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.10
Confidence Interval (2-Sided) 80%
-0.50 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.310
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 7
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8083
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.08
Confidence Interval (2-Sided) 80%
-0.48 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.314
Estimation Comments A difference in adjusted means of <0 favors RO7496998 (AT-527).
3.Secondary Outcome
Title Time to Cessation of SARS-CoV-2 Viral Shedding
Hide Description Time to cessation of viral shedding was defined as the time between the initiation of any study treatment and the first time when a negative or below the limit of detection RT-PCR test result was obtained. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.
Time Frame Up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
NA [1] 
(144.2 to NA)
NA [1] 
(143.8 to NA)
NA [1] 
(141.1 to NA)
[1]
NA = Not estimable due to low number of participants with event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 550 mg (1x550 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 80%
0.53 to 1.74
Estimation Comments Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.33
Confidence Interval (2-Sided) 80%
0.76 to 2.32
Estimation Comments Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).
4.Secondary Outcome
Title Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA
Hide Description Time to sustained non-detectable SARS-CoV-2 virus RNA was defined as the time between the initiation of any study treatment and first time when a negative or below the limit of detection test result by RT-PCR is obtained after which no positive test above or equal to the limit of detection was reported. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.
Time Frame Up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Not estimable due to low number of participants with event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 550 mg (1x550 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 80%
0.44 to 1.70
Estimation Comments Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 80%
0.56 to 2.03
Estimation Comments Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).
5.Secondary Outcome
Title Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints
Hide Description Reported here is the percentage of participants with a positive virus RNA by RT-PCR test result above or equal to the limit of quantification (LOQ). RT-PCR was measured from NP swabs.
Time Frame Baseline, Day 3, Day 5, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 40 participants 30 participants 30 participants
100 100 96.7
Day 3 Number Analyzed 40 participants 30 participants 29 participants
95.0 100 93.1
Day 5 Number Analyzed 38 participants 30 participants 30 participants
84.2 90.0 83.3
Day 7 Number Analyzed 39 participants 29 participants 30 participants
76.9 79.3 76.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 550 mg (1x550 mg)
Comments Day 3
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value 5.00
Confidence Interval (2-Sided) 80%
-0.16 to 10.16
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 3
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value -1.90
Confidence Interval (2-Sided) 80%
-9.20 to 5.41
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 550 mg (1x550 mg)
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value 5.79
Confidence Interval (2-Sided) 80%
-4.82 to 16.40
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value -0.88
Confidence Interval (2-Sided) 80%
-12.40 to 10.65
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 550 mg (1x550 mg)
Comments Day 7
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value 2.39
Confidence Interval (2-Sided) 80%
-10.64 to 15.42
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, AT-527 1100 mg (4x275 mg)
Comments Day 7
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Positivity
Estimated Value -0.26
Confidence Interval (2-Sided) 80%
-13.39 to 12.88
Estimation Comments Confidence interval estimated with the Farrington-Manning method.
6.Secondary Outcome
Title Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA
Hide Description AUC is the amount of SARS-CoV-2 virus RNA from baseline to the last sample timepoint and was calculated using the trapezoidal method. RT-PCR was measured from NP swabs.
Time Frame Baseline, Day 3, Day 5, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL*hour
651.56  (189.10) 733.70  (146.63) 618.62  (194.88)
7.Secondary Outcome
Title Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
Hide Description COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 21.5 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
43.4
(9.3 to 104.7)
57.2
(9.0 to 115.8)
56.4
(2.5 to 96.4)
8.Secondary Outcome
Title Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)
Hide Description COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 43 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
43.4
(9.3 to 104.7)
57.2
(9.0 to 141.2)
58.1
(2.5 to 118.2)
9.Secondary Outcome
Title Time to Alleviation of COVID-19 Symptoms (21.5 Hours)
Hide Description COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
43.4
(9.3 to 104.7)
57.2
(9.0 to 115.8)
56.4
(8.2 to 96.4)
10.Secondary Outcome
Title Time to Alleviation of COVID-19 Symptoms (43 Hours)
Hide Description COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 43 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
43.4
(9.3 to 104.7)
57.2
(9.0 to 141.2)
58.1
(8.2 to 118.2)
11.Secondary Outcome
Title Duration of Fever
Hide Description Duration of fever was defined as the time from start of treatment to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization. Only participants who had a fever (temperature > 37.5 degrees Celsius) at baseline are included.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 2 0 0
Median (Inter-Quartile Range)
Unit of Measure: hours
10.6
(9.6 to 11.7)
12.Secondary Outcome
Title Percentage of Participants With COVID-19 Related Complications
Hide Description COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis, and cardiac failure.
Time Frame Up to 33 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Measure Type: Number
Unit of Measure: percentage of participants
0 3.3 3.3
13.Secondary Outcome
Title Time to Alleviation of an Individual Symptom
Hide Description The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 was recorded on a 4-point Likert scale (none=0, mild=1, moderate=2, severe=3). Items 13-14 were recorded on a 3-point Likert scale (same as usual=0, less than usual=1, no sense=2). Time to alleviation of an individual symptom was defined as the time taken from the start of treatment to the point at which the following criterion was met and maintained (for each individual symptom) for at least 21.5 hours: score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary; score of 0 for Items 13 and 14 of the COVID-19 Symptom Diary.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization. Only participants with a baseline score of > 1 for Items 1 - 12 or > 0 for Items 13 - 14 of the COVID-19 Symptom Diary were included in the analysis.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Median (Inter-Quartile Range)
Unit of Measure: hours
Nasal Congestion/Runny Nose Number Analyzed 12 participants 8 participants 10 participants
27.6
(11.3 to 59.9)
34.2
(15.8 to 82.4)
32.7
(10.0 to 57.7)
Sore Throat Number Analyzed 5 participants 5 participants 2 participants
20.5
(14.1 to 22.7)
24.1
(9.8 to 45.0)
111.7
(22.1 to 201.4)
Cough Number Analyzed 11 participants 6 participants 7 participants
22.6
(11.8 to 129.3)
90.7
(23.7 to 140.4)
33.9
(20.5 to 119.2)
Shortness of Breath Number Analyzed 3 participants 2 participants 1 participants
23.9 [1] 
(11.5 to NA)
68.9
(68.5 to 69.2)
11.6
(11.6 to 11.6)
Aches and Pains Number Analyzed 8 participants 8 participants 4 participants
33.1
(11.8 to 60.4)
22.3
(16.3 to 62.2)
94.4
(48.1 to 177.7)
Fatigue Number Analyzed 15 participants 10 participants 11 participants
47.8
(22.6 to 178.1)
44.4
(10.5 to 94.5)
70.6
(22.6 to 106.0)
Headache Number Analyzed 13 participants 7 participants 11 participants
32.0
(10.1 to 95.8)
11.7
(9.8 to 93.6)
34.4
(21.8 to 105.4)
Chills/Sweats Number Analyzed 8 participants 3 participants 4 participants
11.8
(9.8 to 24.1)
12.0
(9.0 to 35.8)
25.0
(17.1 to 41.4)
Feeling Hot or Feverish Number Analyzed 6 participants 2 participants 4 participants
26.5
(11.8 to 35.7)
48.0
(24.0 to 72.0)
40.3
(15.9 to 63.4)
Nausea Number Analyzed 2 participants 0 participants 0 participants
NA [1] 
(21.1 to NA)
Vomiting Number Analyzed 2 participants 0 participants 0 participants
NA [1] 
(11.0 to NA)
Diarrhea Number Analyzed 1 participants 0 participants 1 participants
NA [1] 
(NA to NA)
9.8
(9.8 to 9.8)
Sense of Smell Number Analyzed 19 participants 14 participants 18 participants
261.5 [1] 
(164.9 to NA)
290.2 [1] 
(130.7 to NA)
213.1
(129.7 to 513.7)
Sense of Taste Number Analyzed 16 participants 12 participants 17 participants
221.1
(165.3 to 297.6)
214.1 [1] 
(94.1 to NA)
178.5
(105.5 to 391.2)
[1]
NA: not estimable due to low number of participants with an event.
14.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention.
Time Frame Up to 33 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all participants who received any amount of study drug and were grouped according to the treatment that the participants actually received rather than the treatment assigned at randomization.
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 40 30 30
Measure Type: Number
Unit of Measure: percentage of participants
27.5 20.0 33.3
15.Secondary Outcome
Title Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 550 mg AT-527
Hide Description AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.
Time Frame Day 1: pre-dose, 1 hour, 3 hours; Day 3: pre-dose; Day 5: pre-dose, 3 hours, 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population consisted of all participants randomized into the study who had at least one post-dose drug concentration measurement at a scheduled visit timepoint.
Arm/Group Title AT-527 550 mg (1x550 mg)
Hide Arm/Group Description:
Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
AT-511: Day 1, pre-dose Number Analyzed 30 participants
1.3  (4.5)
AT-511: Day 1, 1 hour Number Analyzed 30 participants
1950.5  (2365.0)
AT-511: Day 1, 3 hours Number Analyzed 29 participants
441.4  (645.8)
AT-511: Day 3, pre-dose Number Analyzed 28 participants
254.2  (943.1)
AT-511: Day 5, pre-dose Number Analyzed 30 participants
5.6  (21.9)
AT-511: Day 5, 3 hours Number Analyzed 30 participants
415.7  (445.5)
AT-511: Day 5, 48 hours Number Analyzed 29 participants
0.5  (0.0)
AT-551: Day 1, pre-dose Number Analyzed 30 participants
0.5  (0.0)
AT-551: Day 1, 1 hour Number Analyzed 30 participants
347.5  (334.1)
AT-551: Day 1, 3 hours Number Analyzed 29 participants
375.8  (303.9)
AT-551: Day 3, pre-dose Number Analyzed 28 participants
56.9  (100.1)
AT-551: Day 5, pre-dose Number Analyzed 30 participants
26.6  (22.7)
AT-551: Day 5, 3 hours Number Analyzed 30 participants
323.8  (168.3)
AT-551: Day 5, 48 hours Number Analyzed 29 participants
1.7  (1.4)
AT-229: Day 1, pre-dose Number Analyzed 30 participants
0.5  (0.0)
AT-229: Day 1, 1 hour Number Analyzed 30 participants
268.5  (318.5)
AT-229: Day 1, 3 hours Number Analyzed 29 participants
427.4  (275.8)
AT-229: Day 3, pre-dose Number Analyzed 28 participants
290.3  (152.3)
AT-229: Day 5, pre-dose Number Analyzed 30 participants
295.4  (145.0)
AT-229: Day 5, 3 hours Number Analyzed 30 participants
773.9  (340.8)
AT-229: Day 5, 48 hours Number Analyzed 29 participants
89.2  (87.8)
AT-273: Day 1, pre-dose Number Analyzed 30 participants
0.5  (0.0)
AT-273: Day 1, 1 hour Number Analyzed 30 participants
26.5  (29.0)
AT-273: Day 1, 3 hours Number Analyzed 29 participants
132.2  (66.7)
AT-273: Day 3, pre-dose Number Analyzed 28 participants
135.9  (47.6)
AT-273: Day 5, pre-dose Number Analyzed 30 participants
138.1  (53.0)
AT-273: Day 5, 3 hours Number Analyzed 30 participants
236.9  (79.9)
AT-273: Day 5, 48 hours Number Analyzed 29 participants
40.9  (22.7)
16.Secondary Outcome
Title Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 1100 mg AT-527
Hide Description AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.
Time Frame Day 1: pre-dose, 1 hour, 4 hours; Day 3: pre-dose; Day 5: pre-dose, 1 hour, 4 hours, 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population consisted of all participants randomized into the study who had at least one post-dose drug concentration measurement at a scheduled visit timepoint.
Arm/Group Title AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description:
Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
AT-511: Day 1, pre-dose Number Analyzed 29 participants
0.5  (0.0)
AT-511: Day 1, 1 hour Number Analyzed 29 participants
3575.0  (2883.6)
AT-511: Day 1, 4 hours Number Analyzed 30 participants
852.4  (1513.2)
AT-511: Day 3, pre-dose Number Analyzed 24 participants
9.6  (15.9)
AT-511: Day 5, pre-dose Number Analyzed 26 participants
316.7  (1544.7)
AT-511: Day 5, 1 hour Number Analyzed 25 participants
3568.9  (3352.1)
AT-511: Day 5, 4 hours Number Analyzed 23 participants
1323.3  (2883.5)
AT-511: Day 5, 48 hours Number Analyzed 24 participants
0.6  (0.6)
AT-551: Day 1, pre-dose Number Analyzed 29 participants
0.5  (0.0)
AT-551: Day 1, 1 hour Number Analyzed 29 participants
592.2  (576.9)
AT-551: Day 1, 4 hours Number Analyzed 30 participants
640.4  (446.3)
AT-551: Day 3, pre-dose Number Analyzed 25 participants
84.0  (72.1)
AT-551: Day 5, pre-dose Number Analyzed 26 participants
71.3  (61.6)
AT-551: Day 5, 1 hour Number Analyzed 25 participants
302.8  (222.1)
AT-551: Day 5, 4 hours Number Analyzed 23 participants
342.1  (254.9)
AT-551: Day 5, 48 hours Number Analyzed 24 participants
4.4  (4.8)
AT-229: Day 1, pre-dose Number Analyzed 29 participants
0.5  (0.0)
AT-229: Day 1, 1 hour Number Analyzed 29 participants
371.9  (460.3)
AT-229: Day 1, 4 hours Number Analyzed 30 participants
865.4  (494.2)
AT-229: Day 3, pre-dose Number Analyzed 25 participants
682.8  (351.7)
AT-229: Day 5, pre-dose Number Analyzed 26 participants
797.8  (459.9)
AT-229: Day 5, 1 hour Number Analyzed 25 participants
990.9  (505.3)
AT-229: Day 5, 4 hours Number Analyzed 23 participants
1357.2  (825.3)
AT-229: Day 5, 48 hours Number Analyzed 24 participants
279.4  (285.3)
AT-273: Day 1, pre-dose Number Analyzed 29 participants
0.5  (0.0)
AT-273: Day 1, 1 hour Number Analyzed 29 participants
35.7  (47.4)
AT-273: Day 1, 4 hours Number Analyzed 30 participants
231.8  (111.4)
AT-273: Day 3, pre-dose Number Analyzed 25 participants
245.6  (122.8)
AT-273: Day 5, pre-dose Number Analyzed 26 participants
263.6  (107.3)
AT-273: Day 5, 1 hour Number Analyzed 25 participants
252.1  (97.4)
AT-273: Day 5, 4 hours Number Analyzed 23 participants
310.6  (107.5)
AT-273: Day 5, 48 hours Number Analyzed 24 participants
84.4  (45.5)
Time Frame Up to 33 days
Adverse Event Reporting Description Safety Population consisted of all participants who received any amount of study drug and were grouped according to the treatment that the participants actually received rather than the treatment assigned at randomization.
 
Arm/Group Title Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Hide Arm/Group Description Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5. Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5. Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.
All-Cause Mortality
Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/30 (3.33%)      1/30 (3.33%)    
Cardiac disorders       
Atrial flutter † 1  1/40 (2.50%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations       
COVID-19 pneumonia † 1  0/40 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pooled Placebo AT-527 550 mg (1x550 mg) AT-527 1100 mg (4x275 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/30 (3.33%)      5/30 (16.67%)    
Gastrointestinal disorders       
Nausea † 1  1/40 (2.50%)  1 1/30 (3.33%)  1 3/30 (10.00%)  3
Vomiting † 1  1/40 (2.50%)  1 0/30 (0.00%)  0 5/30 (16.67%)  5
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04709835    
Other Study ID Numbers: WV43042
2020-005366-34 ( EudraCT Number )
First Submitted: January 12, 2021
First Posted: January 14, 2021
Results First Submitted: September 15, 2022
Results First Posted: October 13, 2022
Last Update Posted: October 26, 2022