Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19 (NCT NCT04380961)

Last Updated: 2022-06-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

212 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2022-06-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Sirukumab + SOC 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.	Placebo + SOC 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 Study STARTED	140	72
Overall Study Treated	139	70
Overall Study Participants Who Entered the Follow-up Phase	118	57
Overall Study COMPLETED	96	43
Overall Study NOT COMPLETED	44	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Sirukumab + SOC 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.	Placebo + SOC 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 Study Lost to Follow-up	17	11
Overall Study Withdrawal by Subject	3	0
Overall Study Death	22	16
Overall Study Other	1	0
Overall Study Randomized but Not Treated	1	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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 n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants	48 Participants n=7 Participants	142 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	22 Participants n=7 Participants	67 Participants n=5 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 12.91 • n=5 Participants	57.8 years STANDARD_DEVIATION 12.91 • n=7 Participants	57.8 years STANDARD_DEVIATION 12.88 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	25 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	45 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	64 Participants n=5 Participants	36 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants	34 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	51 Participants n=7 Participants	155 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment UNITED STATES	139 Participants n=5 Participants	70 Participants n=7 Participants	209 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: 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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=72 Participants 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.	Placebo + SOC n=40 Participants 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.
Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal Clinical Recovery Scale (CRS): Primary Analysis Set	17.00 Days Interval 13.0 to NA stands for data Not available as indicates upper limit of 95% CI was not estimable due to less number of events.	23.00 Days Interval 13.0 to NA stands for data Not available as indicates upper limit of 95% CI was not estimable due to less number of events.

SECONDARY outcome

Timeframe: Day 28

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=69 Participants 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.	Placebo + SOC n=40 Participants 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.
Percentage of Participants With an Improvement of At Least 2 Categories Compared to Baseline on 6-point Ordinal CRS	59.4 Percentage of Participants	55.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 28 days

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=69 Participants 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.	Placebo + SOC n=40 Participants 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.
Percentage of Participants With All-cause Mortality Up to 28 Days	24.6 Percentage of Participants	30.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT analysis set consisted of all participants who were randomized and treated in the study.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal CRS: Intent-to-Treat (ITT) Set	9.00 Days Interval 7.0 to 10.0	10.00 Days Interval 8.0 to 17.0

SECONDARY outcome

Timeframe: Day 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=136 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With an Improvement of at Least 2 Categories Compared to Baseline on 6-point Ordinal CRS: ITT Set	77.9 Percentage of Participants	70.0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 28

Percentage of participants with all-cause mortality were reported. All-cause mortality included all deaths of participants due to any cause.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=136 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With All-cause Mortality: ITT Set	13.2 Percentage of Participants	18.6 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The All Subjects treated analysis set consisted of all participants who received the study drug.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With Serious Adverse Events (SAEs) (Treatment Phase)	25.2 Percentage of Participants	31.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The All Subjects Treated analysis set consisted of all participants who received the study drug.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With Related Adverse Events (AEs)	11.5 Percentage of Participants	7.1 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The All Subjects treated analysis set consisted of all participants who received the study drug.

Percentage of participants with severe or Life-threatening, bacterial, invasive fungal, viral or opportunistic infections were reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With Severe or Life-threatening, Bacterial, Invasive Fungal, Viral or Opportunistic Infections	11.5 Percentage of Participants	11.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=137 Participants 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.	Placebo + SOC n=69 Participants 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.
Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia Neutropenia: Grade 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia Neutropenia: Grade 4	0.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia Lymphocytopenia: Grade 3	6.6 Percentage of Participants	7.2 Percentage of Participants
Percentage of Participants With Grade 3 and 4 Neutropenia and Lymphocytopenia Lymphocytopenia: Grade 4	6.6 Percentage of Participants	10.1 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The All Subjects Treated analysis set consists of all participants who received the study drug.

Percentage of participants with increased ALT \>=3\*ULN combined with increased bilirubin \>2\*ULN were reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With Increased Alanine Transaminase (ALT) Greater Than or Equal to (>=)3Upper Limit Normal (ULN) Combined With Increased Bilirubin Greater Than (>)2ULN	2.2 Percentage of Participants	1.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=72 Participants 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.	Placebo + SOC n=40 Participants 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.
Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: Primary Analysis Set	9.00 Days Interval 7.0 to 21.0	15.50 Days Interval 8.0 to NA stands for data Not available, indicates upper limit of 90% CI was not estimable due to less number of events.

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT analysis set consisted of all participants who were randomized and treated in the study.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Time to Sustained Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set	7.00 Days Interval 6.0 to 8.0	7.00 Days Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: Day 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=69 Participants 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.	Placebo + SOC n=40 Participants 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.
Percentage of Participants With an Improvement of at Least 1 Category Compared to Baseline on 6-point Ordinal CRS: Primary Analysis Set	62.3 Percentage of Participants	57.5 Percentage of Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=136 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With an Improvement of at Least 1 Category on 6-point Ordinal CRS: ITT Set	80.1 Percentage of Participants	74.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT analysis set consisted of all participants who were randomized and treated in the study.

Time from study intervention administration to end of oxygen supplementation was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=139 Participants 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.	Placebo + SOC n=70 Participants 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.
Time From Study Intervention Administration to End of Oxygen Supplementation	24.0 Days Interval 10.0 to NA indicates data not available as upper limit of 90% CI was not estimable due to less number of events.	20.00 Days Interval 9.0 to NA indicates data not available as upper limit of 90% CI was not estimable due to less number of events.

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT population restricted to participants surviving up to Day 28.

Time from study intervention administration to hospital discharge among the surviving participants was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=118 Participants 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.	Placebo + SOC n=57 Participants 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.
Time From Study Intervention Administration to Hospital Discharge Among the Surviving Participants	8.00 Days Interval 7.0 to 9.0	9.00 Days Interval 7.0 to 10.0

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT population restricted to participants surviving up to Day 28.

Total length of hospitalization, defined as total duration of hospital stay, among the surviving participants was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=118 Participants 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.	Placebo + SOC n=57 Participants 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 Length of Hospitalization Among the Surviving Participants	10.42 Days Standard Deviation 8.274	11.19 Days Standard Deviation 8.370

SECONDARY outcome

Timeframe: Up to Day 28

Population: 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.

Number of ventilation free days in participants on invasive mechanical ventilation (IVM)/extracorporeal membrane oxygenation (ECMO) at baseline was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=11 Participants 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.	Placebo + SOC n=8 Participants 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.
Number of Ventilation Free Days	13.82 Days Standard Deviation 11.062	6.63 Days Standard Deviation 9.546

SECONDARY outcome

Timeframe: On Day 7, 14, 21, 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=71 Participants 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.	Placebo + SOC n=40 Participants 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.
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 1.1	7.0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 1.2	4.2 Percentage of Participants	2.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 2	4.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 3	22.5 Percentage of Participants	25.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 4	33.8 Percentage of Participants	32.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 5	25.4 Percentage of Participants	35.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 7: Category 6	2.8 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 1.1	20.3 Percentage of Participants	17.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 1.2	20.3 Percentage of Participants	15.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 2	1.4 Percentage of Participants	2.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 3	13.0 Percentage of Participants	15.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 4	13.0 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 5	20.3 Percentage of Participants	27.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 14: Category 6	11.6 Percentage of Participants	12.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 1.1	23.2 Percentage of Participants	20.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 1.2	26.1 Percentage of Participants	22.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 2	1.4 Percentage of Participants	7.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 3	10.1 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 4	7.2 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 5	17.4 Percentage of Participants	20.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 21: Category 6	14.5 Percentage of Participants	20.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 1.1	29.0 Percentage of Participants	25.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 1.2	27.5 Percentage of Participants	25.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 2	0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 3	5.8 Percentage of Participants	2.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 4	4.3 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 5	8.7 Percentage of Participants	12.5 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: Primary Analysis Set Day 28: Category 6	24.6 Percentage of Participants	30.0 Percentage of Participants

SECONDARY outcome

Timeframe: On Days 7, 14, 21, 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=138 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 1.1	31.9 Percentage of Participants	30.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 1.2	8.7 Percentage of Participants	5.7 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 2	5.1 Percentage of Participants	4.3 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 3	20.3 Percentage of Participants	20.0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 4	18.8 Percentage of Participants	18.6 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 5	13.8 Percentage of Participants	21.4 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 7: Category 6	1.4 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 1.1	44.1 Percentage of Participants	42.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 1.2	24.3 Percentage of Participants	17.1 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 2	0.7 Percentage of Participants	1.4 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 3	6.6 Percentage of Participants	8.6 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 4	7.4 Percentage of Participants	5.7 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 5	10.3 Percentage of Participants	15.7 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 14: Category 6	6.6 Percentage of Participants	8.6 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 1.1	45.6 Percentage of Participants	44.3 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 1.2	27.9 Percentage of Participants	21.4 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 2	0.7 Percentage of Participants	4.3 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 3	5.1 Percentage of Participants	2.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 4	3.7 Percentage of Participants	2.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 5	8.8 Percentage of Participants	11.4 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 21: Category 6	8.1 Percentage of Participants	12.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 1.1	48.5 Percentage of Participants	47.1 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 1.2	28.7 Percentage of Participants	22.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 2	0 Percentage of Participants	2.9 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 3	2.9 Percentage of Participants	1.4 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 4	2.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 5	4.4 Percentage of Participants	7.1 Percentage of Participants
Percentage of Participants With Clinical Status as Assessed by 6-point Ordinal CRS: ITT Set Day 28: Category 6	13.2 Percentage of Participants	18.6 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: 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.

Total time on invasive mechanical ventilation in participants who were on invasive mechanical ventilation at baseline was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=11 Participants 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.	Placebo + SOC n=8 Participants 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 Time on Invasive Mechanical Ventilation	14.18 Days Standard Deviation 11.062	21.37 Days Standard Deviation 9.546

SECONDARY outcome

Timeframe: From Day 5 up to Day 28

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=136 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Participants With a Worse Category Relative to Baseline on the 6-point Ordinal CRS	25.0 Percentage of Participants	31.4 Percentage of Participants

SECONDARY outcome

Timeframe: From Day 1 up to Day 28

Population: The ITT population restricted to participants who were on ECMO at baseline.

Percentage of participants with ECMO over time were reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=2 Participants 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.	Placebo + SOC n=3 Participants 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.
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 1	100.0 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 2	0 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 4	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 5	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 6	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 7	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 8	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 9	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 10	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 11	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 12	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 13	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 14	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 15	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 16	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 17	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 18	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 19	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 20	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 21	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 22	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 23	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 24	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 25	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 26	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 27	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Extracorporeal Membrane Oxygenation (ECMO) Over Time Day 28	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT set restricted to participants who were on ECMO at baseline.

Total time for participants on ECMO was reported.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=2 Participants 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.	Placebo + SOC n=3 Participants 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 Time on ECMO	1.0 Days Standard Deviation 0	1.3 Days Standard Deviation 0.58

SECONDARY outcome

Timeframe: On Day 28, Week 8 and Week 16

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.

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=136 Participants 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.	Placebo + SOC n=70 Participants 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.
Percentage of Alive Participants at Day 28, Week 8, and Week 16 Day 28	86.8 Percentage of Participants	81.4 Percentage of Participants
Percentage of Alive Participants at Day 28, Week 8, and Week 16 Week 16	81.3 Percentage of Participants	72.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8 and Week 16

Population: The ITT analysis set consisted of all participants who were randomized and treated in the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Week 4 up to Week 16

Outcome measures

Outcome measures
Measure	Sirukumab + SOC n=118 Participants 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.	Placebo + SOC n=57 Participants 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.
Percentage of Participants With SAEs (Follow-up Phase)	5.9 Percentage of Participants	5.3 Percentage of Participants

Adverse Events

Sirukumab + Standard of Care (SOC): Treatment Phase

Serious events: 35 serious events

Other events: 24 other events

Deaths: 18 deaths

Sirukumab + SOC: Follow-up Phase

Serious events: 7 serious events

Other events: 1 other events

Deaths: 4 deaths

Placebo + SOC: Treatment Phase

Serious events: 22 serious events

Other events: 16 other events

Deaths: 13 deaths

Placebo + SOC: Follow-up Phase

Serious events: 3 serious events

Other events: 1 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sirukumab + Standard of Care (SOC): Treatment Phase n=139 participants at risk 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.	Sirukumab + SOC: Follow-up Phase n=118 participants at risk 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.	Placebo + SOC: Treatment Phase n=70 participants at risk 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.	Placebo + SOC: Follow-up Phase n=57 participants at risk 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.
Blood and lymphatic system disorders Leukocytosis	5.8% 8/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.85% 1/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	8.6% 6/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.
Investigations Alanine Aminotransferase Increased	5.0% 7/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	2.9% 2/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.
Investigations Transaminases Increased	5.8% 8/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	2.9% 2/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.
Investigations Troponin Increased	0.72% 1/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	5.7% 4/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.
Renal and urinary disorders Acute Kidney Injury	2.9% 4/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	7.1% 5/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	1.8% 1/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.
Vascular disorders Hypotension	3.6% 5/139 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/118 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	7.1% 5/70 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.	0.00% 0/57 • Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16 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.

Additional Information

Director 1 Study Responsible Physician

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER