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A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (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: NCT04380961
Recruitment Status : Completed
First Posted : May 8, 2020
Results First Posted : June 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Critical Confirmed Coronavirus Disease (COVID)-19
Interventions Drug: Sirukumab
Drug: Placebo
Other: Standard of Care (SOC)
Enrollment 212
Recruitment Details  
Pre-assignment Details Out of 212 participants who started the study and got randomized, 209 participants (139 in Sirukumab + Standard of Care [SOC] and 70 in Placebo + SOC arm) were treated. Out of 212, 139 participants (96 in Sirukumab + SOC and 43 in Placebo + SOC arms) completed the study.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator. Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Period Title: Overall Study
Started 140 72
Treated 139 70
Participants Who Entered the Follow-up Phase 118 57
Completed 96 43
Not Completed 44 29
Reason Not Completed
Lost to Follow-up             17             11
Withdrawal by Subject             3             0
Death             22             16
Other             1             0
Randomized but Not Treated             1             2
Arm/Group Title Sirukumab + SOC Placebo + SOC Total
Hide Arm/Group Description Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator. Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator. Total of all reporting groups
Overall Number of Baseline Participants 139 70 209
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) analysis set consisted of all participants who were randomized and treated in the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 70 participants 209 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
94
  67.6%
48
  68.6%
142
  67.9%
>=65 years
45
  32.4%
22
  31.4%
67
  32.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 70 participants 209 participants
57.8  (12.91) 57.8  (12.91) 57.8  (12.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 70 participants 209 participants
Female
41
  29.5%
25
  35.7%
66
  31.6%
Male
98
  70.5%
45
  64.3%
143
  68.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 70 participants 209 participants
Hispanic or Latino
64
  46.0%
36
  51.4%
100
  47.8%
Not Hispanic or Latino
75
  54.0%
34
  48.6%
109
  52.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 70 participants 209 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
1
   0.5%
Asian
7
   5.0%
3
   4.3%
10
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  12.9%
11
  15.7%
29
  13.9%
White
104
  74.8%
51
  72.9%
155
  74.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
   6.5%
5
   7.1%
14
   6.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
UNITED STATES Number Analyzed 139 participants 70 participants 209 participants
139
 100.0%
70
 100.0%
209
 100.0%
1.Primary Outcome
Title Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal Clinical Recovery Scale (CRS): Primary Analysis Set
Hide Description Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the Intent-to-Treat (ITT) analysis set (which consisted of all participants who were randomized and treated in the study) with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 72 40
Median (95% Confidence Interval)
Unit of Measure: Days
17.00 [1] 
(13.00 to NA)
23.00 [1] 
(13.00 to NA)
[1]
NA stands for data Not available as indicates upper limit of 95% CI was not estimable due to less number of events.
2.Secondary Outcome
Title Percentage of Participants With an Improvement of At Least 2 Categories Compared to Baseline on 6-point Ordinal CRS
Hide Description Percentage of participants with an improvement of at least 2 Categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 69 40
Measure Type: Number
Unit of Measure: Percentage of Participants
59.4 55.0
3.Secondary Outcome
Title Percentage of Participants With All-cause Mortality Up to 28 Days
Hide Description Percentage of participants with all-cause mortality up to 28 days were reported. All-cause mortality included all deaths of participants due to any cause.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 69 40
Measure Type: Number
Unit of Measure: Percentage of Participants
24.6 30.0
4.Secondary Outcome
Title Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal CRS: Intent-to-Treat (ITT) Set
Hide Description Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Median (95% Confidence Interval)
Unit of Measure: Days
9.00
(7.00 to 10.00)
10.00
(8.00 to 17.00)
5.Secondary Outcome
Title Percentage of Participants With an Improvement of at Least 2 Categories Compared to Baseline on 6-point Ordinal CRS: ITT Set
Hide Description Percentage of participants with an improvement of at least 2 categories compared to baseline on 6-point ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 136 70
Measure Type: Number
Unit of Measure: Percentage of Participants
77.9 70.0
6.Secondary Outcome
Title Percentage of Participants With All-cause Mortality: ITT Set
Hide Description Percentage of participants with all-cause mortality were reported. All-cause mortality included all deaths of participants due to any cause.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 136 70
Measure Type: Number
Unit of Measure: Percentage of Participants
13.2 18.6
7.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) (Treatment Phase)
Hide Description Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects treated analysis set consisted of all participants who received the study drug.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Measure Type: Number
Unit of Measure: Percentage of Participants
25.2 31.4
8.Secondary Outcome
Title Percentage of Participants With Related Adverse Events (AEs)
Hide Description Percentage of participants with related AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects Treated analysis set consisted of all participants who received the study drug.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Measure Type: Number
Unit of Measure: Percentage of Participants
11.5 7.1
9.Secondary Outcome
Title Percentage of Participants With Severe or Life-threatening, Bacterial, Invasive Fungal, Viral or Opportunistic Infections
Hide Description Percentage of participants with severe or Life-threatening, bacterial, invasive fungal, viral or opportunistic infections were reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects treated analysis set consisted of all participants who received the study drug.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Measure Type: Number
Unit of Measure: Percentage of Participants
11.5 11.4
10.Secondary Outcome
Title Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia
Hide Description Percentage of participants with Grade 3 and 4 neutropenia and lymphocytopenia were reported. The laboratory abnormalities were determined as per division of microbiology and infectious diseases (DMID) adult toxicity as Grade 1: mild (transient or mild discomfort [less than {<} 48 hours]; no medical intervention/therapy required); Grade 2: moderate (mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3: severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4: life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects Treated analysis set consists of all participants who received the study drug. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 137 69
Measure Type: Number
Unit of Measure: Percentage of Participants
Neutropenia: Grade 3 Number Analyzed 136 participants 69 participants
0 0
Neutropenia: Grade 4 Number Analyzed 136 participants 69 participants
0.7 0
Lymphocytopenia: Grade 3 Number Analyzed 137 participants 69 participants
6.6 7.2
Lymphocytopenia: Grade 4 Number Analyzed 137 participants 69 participants
6.6 10.1
11.Secondary Outcome
Title Percentage of Participants With Increased Alanine Transaminase (ALT) Greater Than or Equal to (>=)3*Upper Limit Normal (ULN) Combined With Increased Bilirubin Greater Than (>)2*ULN
Hide Description Percentage of participants with increased ALT >=3*ULN combined with increased bilirubin >2*ULN were reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects Treated analysis set consists of all participants who received the study drug.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Measure Type: Number
Unit of Measure: Percentage of Participants
2.2 1.4
12.Secondary Outcome
Title Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: Primary Analysis Set
Hide Description Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 72 40
Median (90% Confidence Interval)
Unit of Measure: Days
9.00
(7.00 to 21.00)
15.50 [1] 
(8.00 to NA)
[1]
NA stands for data Not available, indicates upper limit of 90% CI was not estimable due to less number of events.
13.Secondary Outcome
Title Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set
Hide Description Time to sustained improvement is defined as an improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale, sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Median (90% Confidence Interval)
Unit of Measure: Days
7.00
(6.00 to 8.00)
7.00
(6.00 to 9.00)
14.Secondary Outcome
Title Percentage of Participants With an Improvement of at Least 1 Category Compared to Baseline on 6-point Ordinal CRS: Primary Analysis Set
Hide Description The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6), reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: (category 1) not hospitalized, including participants on low level of oxygen; Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the ITT analysis set with confirmed critical COVID-19 disease defined as score of 4 or 5 on the ordinal CRS at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 69 40
Measure Type: Number
Unit of Measure: Percentage of Participants
62.3 57.5
15.Secondary Outcome
Title Percentage of Participants With an Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set
Hide Description The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure. There were 3 participants in the 'Sirukumab + SOC arm' who discontinued the trial before Day 28 and thus were not evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 136 70
Measure Type: Number
Unit of Measure: Percentage of Participants
80.1 74.3
16.Secondary Outcome
Title Time From Study Intervention Administration to End of Oxygen Supplementation
Hide Description Time from study intervention administration to end of oxygen supplementation was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Median (90% Confidence Interval)
Unit of Measure: Days
24.0 [1] 
(10.00 to NA)
20.00 [1] 
(9.00 to NA)
[1]
NA indicates data not available as upper limit of 90% CI was not estimable due to less number of events.
17.Secondary Outcome
Title Time From Study Intervention Administration to Hospital Discharge Among the Surviving Participants
Hide Description Time from study intervention administration to hospital discharge among the surviving participants was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population restricted to participants surviving up to Day 28.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 118 57
Median (90% Confidence Interval)
Unit of Measure: Days
8.00
(7.00 to 9.00)
9.00
(7.00 to 10.00)
18.Secondary Outcome
Title Total Length of Hospitalization Among the Surviving Participants
Hide Description Total length of hospitalization, defined as total duration of hospital stay, among the surviving participants was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population restricted to participants surviving up to Day 28.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 118 57
Mean (Standard Deviation)
Unit of Measure: Days
10.42  (8.274) 11.19  (8.370)
19.Secondary Outcome
Title Number of Ventilation Free Days
Hide Description Number of ventilation free days in participants on invasive mechanical ventilation (IVM)/extracorporeal membrane oxygenation (ECMO) at baseline was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set restricted to participants who were on IVM/ECMO at baseline. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: Days
13.82  (11.062) 6.63  (9.546)
20.Secondary Outcome
Title Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set
Hide Description Percentage of participants with clinical status as assessed by 6-point Ordinal CRS were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame On Day 7, 14, 21, 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set consisted of all participants in the ITT set with confirmed critical COVID-19 disease defined as score of 4 or 5 on ordinal CRS at baseline. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories at specified timepoints.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 71 40
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 7: Category 1.1 Number Analyzed 71 participants 40 participants
7.0 5.0
Day 7: Category 1.2 Number Analyzed 71 participants 40 participants
4.2 2.5
Day 7: Category 2 Number Analyzed 71 participants 40 participants
4.2 0
Day 7: Category 3 Number Analyzed 71 participants 40 participants
22.5 25.0
Day 7: Category 4 Number Analyzed 71 participants 40 participants
33.8 32.5
Day 7: Category 5 Number Analyzed 71 participants 40 participants
25.4 35.0
Day 7: Category 6 Number Analyzed 71 participants 40 participants
2.8 0
Day 14: Category 1.1 Number Analyzed 69 participants 40 participants
20.3 17.5
Day 14: Category 1.2 Number Analyzed 69 participants 40 participants
20.3 15.0
Day 14: Category 2 Number Analyzed 69 participants 40 participants
1.4 2.5
Day 14: Category 3 Number Analyzed 69 participants 40 participants
13.0 15.0
Day 14: Category 4 Number Analyzed 69 participants 40 participants
13.0 10.0
Day 14: Category 5 Number Analyzed 69 participants 40 participants
20.3 27.5
Day 14: Category 6 Number Analyzed 69 participants 40 participants
11.6 12.5
Day 21: Category 1.1 Number Analyzed 69 participants 40 participants
23.2 20.0
Day 21: Category 1.2 Number Analyzed 69 participants 40 participants
26.1 22.5
Day 21: Category 2 Number Analyzed 69 participants 40 participants
1.4 7.5
Day 21: Category 3 Number Analyzed 69 participants 40 participants
10.1 5.0
Day 21: Category 4 Number Analyzed 69 participants 40 participants
7.2 5.0
Day 21: Category 5 Number Analyzed 69 participants 40 participants
17.4 20.0
Day 21: Category 6 Number Analyzed 69 participants 40 participants
14.5 20.0
Day 28: Category 1.1 Number Analyzed 69 participants 40 participants
29.0 25.0
Day 28: Category 1.2 Number Analyzed 69 participants 40 participants
27.5 25.0
Day 28: Category 2 Number Analyzed 69 participants 40 participants
0 5
Day 28: Category 3 Number Analyzed 69 participants 40 participants
5.8 2.5
Day 28: Category 4 Number Analyzed 69 participants 40 participants
4.3 0
Day 28: Category 5 Number Analyzed 69 participants 40 participants
8.7 12.5
Day 28: Category 6 Number Analyzed 69 participants 40 participants
24.6 30.0
21.Secondary Outcome
Title Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set
Hide Description Percentage of participants with clinical status as assessed by 6-point Ordinal CRS (ITT Set) were reported. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: Not hospitalized, not requiring supplemental oxygen (category 1.1); Not hospitalized, requiring supplemental oxygen (category 1.2); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame On Days 7, 14, 21, 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories at specified timepoints.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 138 70
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 7: Category 1.1 Number Analyzed 138 participants 70 participants
31.9 30.0
Day 7: Category 1.2 Number Analyzed 138 participants 70 participants
8.7 5.7
Day 7: Category 2 Number Analyzed 138 participants 70 participants
5.1 4.3
Day 7: Category 3 Number Analyzed 138 participants 70 participants
20.3 20.0
Day 7: Category 4 Number Analyzed 138 participants 70 participants
18.8 18.6
Day 7: Category 5 Number Analyzed 138 participants 70 participants
13.8 21.4
Day 7: Category 6 Number Analyzed 138 participants 70 participants
1.4 0
Day 14: Category 1.1 Number Analyzed 136 participants 70 participants
44.1 42.9
Day 14: Category 1.2 Number Analyzed 136 participants 70 participants
24.3 17.1
Day 14: Category 2 Number Analyzed 136 participants 70 participants
0.7 1.4
Day 14: Category 3 Number Analyzed 136 participants 70 participants
6.6 8.6
Day 14: Category 4 Number Analyzed 136 participants 70 participants
7.4 5.7
Day 14: Category 5 Number Analyzed 136 participants 70 participants
10.3 15.7
Day 14: Category 6 Number Analyzed 136 participants 70 participants
6.6 8.6
Day 21: Category 1.1 Number Analyzed 136 participants 70 participants
45.6 44.3
Day 21: Category 1.2 Number Analyzed 136 participants 70 participants
27.9 21.4
Day 21: Category 2 Number Analyzed 136 participants 70 participants
0.7 4.3
Day 21: Category 3 Number Analyzed 136 participants 70 participants
5.1 2.9
Day 21: Category 4 Number Analyzed 136 participants 70 participants
3.7 2.9
Day 21: Category 5 Number Analyzed 136 participants 70 participants
8.8 11.4
Day 21: Category 6 Number Analyzed 136 participants 70 participants
8.1 12.9
Day 28: Category 1.1 Number Analyzed 136 participants 70 participants
48.5 47.1
Day 28: Category 1.2 Number Analyzed 136 participants 70 participants
28.7 22.9
Day 28: Category 2 Number Analyzed 136 participants 70 participants
0 2.9
Day 28: Category 3 Number Analyzed 136 participants 70 participants
2.9 1.4
Day 28: Category 4 Number Analyzed 136 participants 70 participants
2.2 0
Day 28: Category 5 Number Analyzed 136 participants 70 participants
4.4 7.1
Day 28: Category 6 Number Analyzed 136 participants 70 participants
13.2 18.6
22.Secondary Outcome
Title Total Time on Invasive Mechanical Ventilation
Hide Description Total time on invasive mechanical ventilation in participants who were on invasive mechanical ventilation at baseline was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis Set restricted to participants who were on invasive mechanical ventilation at baseline. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: Days
14.18  (11.062) 21.37  (9.546)
23.Secondary Outcome
Title Percentage of Participants With a Worse Category Relative to Baseline on the 6-point Ordinal CRS
Hide Description Percentage of participants with a worse category relative to baseline on the 6-point ordinal CRS for at least one of the daily assessment during the reporting period Day 5 and Day 28 were reported. he 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (category 1); Hospitalization, not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.
Time Frame From Day 5 up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 136 70
Measure Type: Number
Unit of Measure: Percentage of Participants
25.0 31.4
24.Secondary Outcome
Title Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time
Hide Description Percentage of participants with ECMO over time were reported.
Time Frame From Day 1 up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population restricted to participants who were on ECMO at baseline.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 2 3
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 1 100.0 100.0
Day 2 0 33.3
Day 3 0 0
Day 4 0 0
Day 5 0 0
Day 6 0 0
Day 7 0 0
Day 8 0 0
Day 9 0 0
Day 10 0 0
Day 11 0 0
Day 12 0 0
Day 13 0 0
Day 14 0 0
Day 15 0 0
Day 16 0 0
Day 17 0 0
Day 18 0 0
Day 19 0 0
Day 20 0 0
Day 21 0 0
Day 22 0 0
Day 23 0 0
Day 24 0 0
Day 25 0 0
Day 26 0 0
Day 27 0 0
Day 28 0 0
25.Secondary Outcome
Title Total Time on ECMO
Hide Description Total time for participants on ECMO was reported.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set restricted to participants who were on ECMO at baseline.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: Days
1.0  (0) 1.3  (0.58)
26.Secondary Outcome
Title Percentage of Alive Participants at Day 28, Week 8, and Week 16
Hide Description Percentage of alive participants at Day 28, Week 8, and Week 16 were reported. For this outcome measure, at Week 8, data was not collected for participants due to pandemic situation.
Time Frame On Day 28, Week 8 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study. Here 'N' (number of participants analyzed) included all participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified timepoints.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 136 70
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 28 Number Analyzed 136 participants 70 participants
86.8 81.4
Week 8 Number Analyzed 0 participants 0 participants
Week 16 Number Analyzed 118 participants 59 participants
81.3 72.9
27.Secondary Outcome
Title Percentage of Alive Participants That Required Readmission at Week 8, and Week 16
Hide Description Percentage of alive participants that required readmission at Week 8, and Week 16 were reported. For this outcome measure, at Week 8 and Week 16, data was not collected for participants due to pandemic situation.
Time Frame Week 8 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all participants who were randomized and treated in the study.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 139 70
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 8 Number Analyzed 0 participants 0 participants
Week 16 Number Analyzed 0 participants 0 participants
28.Secondary Outcome
Title Percentage of Participants With SAEs (Follow-up Phase)
Hide Description Percentage of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame From Week 4 up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects Treated analysis set consists of all participants who received the study drug. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
Arm/Group Title Sirukumab + SOC Placebo + SOC
Hide Arm/Group Description:
Hospitalized participants with confirmed severe or critical coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with standard of care (SOC) treatment per the discretion of the Investigator.
Hospitalized participants with confirmed severe or critical COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
Overall Number of Participants Analyzed 118 57
Measure Type: Number
Unit of Measure: Percentage of Participants
5.9 5.3
Time Frame Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16
Adverse Event Reporting Description The All Subjects Treated analysis set consisted of all participants who received the study drug. The number of participants at risk in placebo arm in follow-up phase were 59 participants, however, the data for 2 participants in placebo arms were not collected due to pandemic situation, and were excluded from the analysis. Therefore, here number of participants at risk are 57 participants.
 
Arm/Group Title Sirukumab + Standard of Care (SOC): Treatment Phase Sirukumab + SOC: Follow-up Phase Placebo + SOC: Treatment Phase Placebo + SOC: Follow-up Phase
Hide Arm/Group Description Hospitalized participants with confirmed coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram [mg/kg]) on Day 1 along with SOC treatment per the discretion of the Investigator. Hospitalized participants with confirmed COVID-19 received IV single dose infusion of sirukumab 5 mg/kg on Day 1 along with SOC treatment per the discretion of the Investigator. Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator. Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator.
All-Cause Mortality
Sirukumab + Standard of Care (SOC): Treatment Phase Sirukumab + SOC: Follow-up Phase Placebo + SOC: Treatment Phase Placebo + SOC: Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/139 (12.95%)   4/118 (3.39%)   13/70 (18.57%)   3/57 (5.26%) 
Hide Serious Adverse Events
Sirukumab + Standard of Care (SOC): Treatment Phase Sirukumab + SOC: Follow-up Phase Placebo + SOC: Treatment Phase Placebo + SOC: Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/139 (25.18%)   7/118 (5.93%)   22/70 (31.43%)   3/57 (5.26%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Blood Loss Anaemia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Disseminated Intravascular Coagulation * 1  0/139 (0.00%)  0/118 (0.00%)  0/70 (0.00%)  1/57 (1.75%) 
Thrombocytopenia * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Cardiac disorders         
Acute Left Ventricular Failure * 1  0/139 (0.00%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
Atrial Fibrillation * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Bradycardia * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Cardiac Arrest * 1  3/139 (2.16%)  1/118 (0.85%)  6/70 (8.57%)  0/57 (0.00%) 
Cardio-Respiratory Arrest * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Cardiogenic Shock * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Myocardial Ischaemia * 1  0/139 (0.00%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
Supraventricular Tachycardia * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal Haemorrhage * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Lower Gastrointestinal Haemorrhage * 1  0/139 (0.00%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
Mallory-Weiss Syndrome * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Mouth Haemorrhage * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Retroperitoneal Haemorrhage * 1  0/139 (0.00%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
General disorders         
Multiple Organ Dysfunction Syndrome * 1  0/139 (0.00%)  0/118 (0.00%)  2/70 (2.86%)  0/57 (0.00%) 
Infections and infestations         
Bacteraemia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  1/57 (1.75%) 
Bacterial Sepsis * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Covid-19 * 1  3/139 (2.16%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Covid-19 Pneumonia * 1  0/139 (0.00%)  1/118 (0.85%)  1/70 (1.43%)  0/57 (0.00%) 
Enterobacter Pneumonia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Enterococcal Bacteraemia * 1  0/139 (0.00%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
Hiv Infection * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Klebsiella Infection * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Pneumonia * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Septic Shock * 1  2/139 (1.44%)  0/118 (0.00%)  2/70 (2.86%)  0/57 (0.00%) 
Staphylococcal Bacteraemia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Streptococcal Bacteraemia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Viral Sepsis * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Investigations         
Alanine Aminotransferase Increased * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Aspartate Aminotransferase Increased * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Glomerular Filtration Rate Decreased * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Hepatic Enzyme Increased * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Transaminases Increased * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Urine Analysis Abnormal * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Metabolism and nutrition disorders         
Hypocalcaemia * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Nervous system disorders         
Cerebrovascular Accident * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Embolic Stroke * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Haemorrhage Intracranial * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Renal and urinary disorders         
Acute Kidney Injury * 1  1/139 (0.72%)  1/118 (0.85%)  4/70 (5.71%)  0/57 (0.00%) 
Oliguria * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Renal Impairment * 1  2/139 (1.44%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute Respiratory Distress Syndrome * 1  12/139 (8.63%)  1/118 (0.85%)  5/70 (7.14%)  0/57 (0.00%) 
Acute Respiratory Failure * 1  5/139 (3.60%)  0/118 (0.00%)  6/70 (8.57%)  2/57 (3.51%) 
Dyspnoea * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Hypoxia * 1  6/139 (4.32%)  0/118 (0.00%)  2/70 (2.86%)  0/57 (0.00%) 
Pleural Effusion * 1  1/139 (0.72%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Pneumomediastinum * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Pneumothorax * 1  3/139 (2.16%)  2/118 (1.69%)  3/70 (4.29%)  0/57 (0.00%) 
Pneumothorax Spontaneous * 1  1/139 (0.72%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Pulmonary Embolism * 1  1/139 (0.72%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Respiratory Failure * 1  3/139 (2.16%)  2/118 (1.69%)  6/70 (8.57%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders         
Subcutaneous Emphysema * 1  1/139 (0.72%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Surgical and medical procedures         
Haemodialysis * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
Vascular disorders         
Hypotension * 1  2/139 (1.44%)  0/118 (0.00%)  0/70 (0.00%)  0/57 (0.00%) 
Orthostatic Hypotension * 1  1/139 (0.72%)  1/118 (0.85%)  0/70 (0.00%)  0/57 (0.00%) 
Shock * 1  0/139 (0.00%)  0/118 (0.00%)  1/70 (1.43%)  0/57 (0.00%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sirukumab + Standard of Care (SOC): Treatment Phase Sirukumab + SOC: Follow-up Phase Placebo + SOC: Treatment Phase Placebo + SOC: Follow-up Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/139 (17.27%)   1/118 (0.85%)   16/70 (22.86%)   1/57 (1.75%) 
Blood and lymphatic system disorders         
Leukocytosis * 1  8/139 (5.76%)  1/118 (0.85%)  6/70 (8.57%)  0/57 (0.00%) 
Investigations         
Alanine Aminotransferase Increased * 1  7/139 (5.04%)  0/118 (0.00%)  2/70 (2.86%)  0/57 (0.00%) 
Transaminases Increased * 1  8/139 (5.76%)  0/118 (0.00%)  2/70 (2.86%)  0/57 (0.00%) 
Troponin Increased * 1  1/139 (0.72%)  0/118 (0.00%)  4/70 (5.71%)  0/57 (0.00%) 
Renal and urinary disorders         
Acute Kidney Injury * 1  4/139 (2.88%)  0/118 (0.00%)  5/70 (7.14%)  1/57 (1.75%) 
Vascular disorders         
Hypotension * 1  5/139 (3.60%)  0/118 (0.00%)  5/70 (7.14%)  0/57 (0.00%) 
1
Term from vocabulary, MedDRA Version 22.1
*
Indicates events were collected by non-systematic assessment
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director 1 Study Responsible Physician
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT04380961    
Other Study ID Numbers: CR108820
CNTO136COV2001 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
2020-003056-32 ( EudraCT Number )
First Submitted: May 7, 2020
First Posted: May 8, 2020
Results First Submitted: April 8, 2022
Results First Posted: June 21, 2022
Last Update Posted: June 21, 2022