Trial Outcomes & Findings for Immune Modulators for Treating COVID-19 (NCT NCT04593940)

NCT ID: NCT04593940

Last Updated: 2023-09-25

Results Overview

Time to recovery by day 28. The number of participants who have recovered by day 28.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1971 participants
• Primary outcome timeframe: Days 1-28
• Results posted on: 2023-09-25

Participant Flow

Participant milestones

Measure	Standard of Care + Infliximab infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Cenicriviroc cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug	Shared Placebo Shared placebo Placebo group was shared among up to all 3 arms for which the participant qualified.
Overall Study STARTED	531	524	360	556
Overall Study COMPLETED	425	394	263	419
Overall Study NOT COMPLETED	106	130	97	137

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Modulators for Treating COVID-19

Baseline characteristics by cohort

Measure	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug	Shared Placebo n=556 Participants placebo group placebo group was shared among up to all 3 arms; whichever arms the participant qualified.	Total n=1971 Participants Total of all reporting groups	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care
Age, Continuous	54.7 years STANDARD_DEVIATION 14.32 • n=5 Participants	55.0 years STANDARD_DEVIATION 14.66 • n=4 Participants	54.8 years STANDARD_DEVIATION 14.64 • n=21 Participants	54.7 years STANDARD_DEVIATION 14.87 • n=5 Participants	54.8 years STANDARD_DEVIATION 14.65 • n=7 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	235 Participants n=4 Participants	753 Participants n=21 Participants	198 Participants n=5 Participants	197 Participants n=7 Participants
Sex: Female, Male Male	237 Participants n=5 Participants	321 Participants n=4 Participants	1218 Participants n=21 Participants	333 Participants n=5 Participants	327 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	159 Participants n=5 Participants	270 Participants n=4 Participants	905 Participants n=21 Participants	257 Participants n=5 Participants	219 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	187 Participants n=5 Participants	275 Participants n=4 Participants	1009 Participants n=21 Participants	264 Participants n=5 Participants	283 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	11 Participants n=4 Participants	57 Participants n=21 Participants	10 Participants n=5 Participants	22 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants	5 Participants n=5 Participants	5 Participants n=7 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	17 Participants n=4 Participants	56 Participants n=21 Participants	12 Participants n=5 Participants	16 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Black or African American	44 Participants n=5 Participants	76 Participants n=4 Participants	274 Participants n=21 Participants	80 Participants n=5 Participants	74 Participants n=7 Participants
Race (NIH/OMB) White	226 Participants n=5 Participants	350 Participants n=4 Participants	1229 Participants n=21 Participants	328 Participants n=5 Participants	325 Participants n=7 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	2 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	73 Participants n=5 Participants	105 Participants n=4 Participants	384 Participants n=21 Participants	103 Participants n=5 Participants	103 Participants n=7 Participants
Region of Enrollment Argentina	33 Participants n=5 Participants	64 Participants n=4 Participants	205 Participants n=21 Participants	56 Participants n=5 Participants	52 Participants n=7 Participants
Region of Enrollment United States	241 Participants n=5 Participants	354 Participants n=4 Participants	1291 Participants n=21 Participants	344 Participants n=5 Participants	352 Participants n=7 Participants
Region of Enrollment Brazil	38 Participants n=5 Participants	57 Participants n=4 Participants	195 Participants n=21 Participants	54 Participants n=5 Participants	46 Participants n=7 Participants
Region of Enrollment Mexico	8 Participants n=5 Participants	18 Participants n=4 Participants	59 Participants n=21 Participants	15 Participants n=5 Participants	18 Participants n=7 Participants
Region of Enrollment Peru	40 Participants n=5 Participants	63 Participants n=4 Participants	221 Participants n=21 Participants	62 Participants n=5 Participants	56 Participants n=7 Participants

PRIMARY outcome

Timeframe: Days 1-28

Population: Intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Time to recovery by day 28. The number of participants who have recovered by day 28.

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Participants Who Had Recovered by Day 28	421 Participants	405 Participants	414 Participants	397 Participants	273 Participants	287 Participants

SECONDARY outcome

Timeframe: Day 14

Population: Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 15 assessing day 14.

The scale used in this study is as follows (from worst to best):

1. Death;

2. Hospitalized, on invasive mechanical ventilation or ECMO;

3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise);

6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc.

7. Not hospitalized, limitation on activities and/or requiring home oxygen

8. Not hospitalized,

Outcome measures

Measure	Standard of Care + Infliximab n=506 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=506 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=493 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=499 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=350 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=346 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 1-Death	29 Participants	42 Participants	24 Participants	40 Participants	31 Participants	25 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 2-Hospitalized, on invasive mechanical ventilation or ECMO	60 Participants	65 Participants	63 Participants	66 Participants	41 Participants	38 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices	19 Participants	23 Participants	31 Participants	26 Participants	17 Participants	15 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 4-Hospitalized, requiring supplemental oxygen	44 Participants	34 Participants	38 Participants	34 Participants	22 Participants	29 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care	4 Participants	11 Participants	13 Participants	11 Participants	6 Participants	10 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 7-Not hospitalized, limitation on activities and/or requiring home oxygen	163 Participants	174 Participants	174 Participants	173 Participants	134 Participants	130 Participants
Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale 8-Not hospitalized	185 Participants	155 Participants	150 Participants	147 Participants	98 Participants	98 Participants

SECONDARY outcome

Timeframe: Day 1-28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

mortality at day 28

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mortality Through 28 Days	53 Participants	75 Participants	56 Participants	77 Participants	49 Participants	42 Participants

SECONDARY outcome

Timeframe: Day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41.

8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 29 assessing day 28.

The scale used in this study is as follows (from worst to best):

1. Death;

2. Hospitalized, on invasive mechanical ventilation or ECMO;

3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise);

6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc.

7. Not hospitalized, limitation on activities and/or requiring home oxygen

8. Not hospitalized,

Outcome measures

Measure	Standard of Care + Infliximab n=496 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=500 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=487 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=493 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=338 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=344 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 1-Death	53 Participants	75 Participants	56 Participants	77 Participants	49 Participants	42 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 2-Hospitalized, on invasive mechanical ventilation or ECMO	28 Participants	27 Participants	27 Participants	26 Participants	25 Participants	19 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 3-Hospitalized, on non-invasive ventilation or high flow oxygen devices	6 Participants	7 Participants	5 Participants	8 Participants	7 Participants	5 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 4-Hospitalized, requiring supplemental oxygen	11 Participants	10 Participants	10 Participants	12 Participants	4 Participants	8 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 5-Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care	3 Participants	6 Participants	8 Participants	5 Participants	2 Participants	4 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 6-Hospitalized, not requiring supplemental oxygen - no longer requires in-patient care	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 7-Not hospitalized, limitation on activities and/or requiring home oxygen	135 Participants	156 Participants	149 Participants	156 Participants	109 Participants	115 Participants
Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale 8-Not hospitalized	258 Participants	217 Participants	231 Participants	207 Participants	142 Participants	149 Participants

SECONDARY outcome

Timeframe: Day 1-14

Population: Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

mortality at day 14

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mortality Through 14 Days	29 Participants	42 Participants	24 Participants	40 Participants	31 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 1-day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a 1 point improvement.

The scale used in this study is as follows (from worst to best):

1. Death;

2. Hospitalized, on invasive mechanical ventilation or ECMO;

3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise);

6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc.

7. Not hospitalized, limitation on activities and/or requiring home oxygen

8. Not hospitalized, no limitations on activities.

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale	446 Participants	429 Participants	435 Participants	421 Participants	287 Participants	302 Participants

SECONDARY outcome

Timeframe: Day 1- day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a two category improvement.

The scale used in this study is as follows (from worst to best):

1. Death;

2. Hospitalized, on invasive mechanical ventilation or ECMO;

3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical in-patient care (COVID-19 related or otherwise);

6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical in-patient care; This would include those kept in hospital for quarantine/infection control/social reasons, awaiting bed in rehabilitation facility or homecare, etc.

7. Not hospitalized, limitation on activities and/or requiring home oxygen

8. Not hospitalized, no limitations on activities.

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale	429 Participants	415 Participants	421 Participants	406 Participants	282 Participants	292 Participants

SECONDARY outcome

Timeframe: Day 0 to day 2

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 24, Abatacept arms 22, CVC arms 9.

8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=519 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=522 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=512 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=515 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=356 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=358 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2	3.5 units on a scale Standard Deviation 0.9104	3.5 units on a scale Standard Deviation 1.0515	3.6 units on a scale Standard Deviation 1.0973	3.5 units on a scale Standard Deviation 1.0403	3.5 units on a scale Standard Deviation 0.9914	3.5 units on a scale Standard Deviation 1.0118

SECONDARY outcome

Timeframe: Day 0 to day 4

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 25, Abatacept arms 32, CVC arms 16.

8 point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=519 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=517 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=507 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=352 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=355 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4	3.9 units on a scale Standard Deviation 1.6004	3.9 units on a scale Standard Deviation 1.5320	4.0 units on a scale Standard Deviation 1.6526	3.9 units on a scale Standard Deviation 1.5468	3.9 units on a scale Standard Deviation 1.6385	3.9 units on a scale Standard Deviation 1.5624

SECONDARY outcome

Timeframe: Day 0 to day 7

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 35, Abatacept arms 43, CVC arms 19.

8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities=best)

Outcome measures

Measure	Standard of Care + Infliximab n=514 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=512 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=501 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=505 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=352 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=352 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7	5.0 units on a scale Standard Deviation 2.2738	4.8 units on a scale Standard Deviation 2.2470	4.9 units on a scale Standard Deviation 2.2261	4.8 units on a scale Standard Deviation 2.2585	4.8 units on a scale Standard Deviation 2.2636	4.9 units on a scale Standard Deviation 2.2475

SECONDARY outcome

Timeframe: Day 0 to day 10

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 45, Abatacept arms 51, CVC arms 24.

8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=509 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=507 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=498 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=500 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=351 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=348 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10	5.6 units on a scale Standard Deviation 2.3910	5.3 units on a scale Standard Deviation 2.4308	5.4 units on a scale Standard Deviation 2.3310	5.3 units on a scale Standard Deviation 2.4306	5.3 units on a scale Standard Deviation 2.4493	5.3 units on a scale Standard Deviation 2.3746

SECONDARY outcome

Timeframe: Day 0 to day 14

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27.

8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=506 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=506 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=493 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=499 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=350 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=346 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14	6.0 units on a scale Standard Deviation 2.4124	5.7 units on a scale Standard Deviation 2.5183	5.8 units on a scale Standard Deviation 2.3911	5.7 units on a scale Standard Deviation 2.5152	5.7 units on a scale Standard Deviation 2.4998	5.8 units on a scale Standard Deviation 2.4102

SECONDARY outcome

Timeframe: Day 0 to day 21

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 57, Abatacept arms 64, CVC arms 35.

8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=501 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=503 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=489 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=496 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=342 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=346 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21	6.3 units on a scale Standard Deviation 2.4025	6.0 units on a scale Standard Deviation 2.5732	6.1 units on a scale Standard Deviation 2.4161	5.9 units on a scale Standard Deviation 2.5887	5.9 units on a scale Standard Deviation 2.6111	6.2 units on a scale Standard Deviation 2.4540

SECONDARY outcome

Timeframe: Day 0 to day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41.

8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best)

Outcome measures

Measure	Standard of Care + Infliximab n=496 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=500 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=487 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=493 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=338 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=344 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28	6.5 units on a scale Standard Deviation 2.4344	6.1 units on a scale Standard Deviation 2.6229	6.4 units on a scale Standard Deviation 2.4560	6.1 units on a scale Standard Deviation 2.6474	6.1 units on a scale Standard Deviation 2.6587	6.3 units on a scale Standard Deviation 2.4869

SECONDARY outcome

Timeframe: Day 1 to day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Days alive and free of supplemental oxygen

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Duration (Days) Alive and Free of Supplemental Oxygen	16.3 days Standard Deviation 9.87	15.2 days Standard Deviation 10.21	15.7 days Standard Deviation 9.95	15.0 days Standard Deviation 10.35	15.3 days Standard Deviation 10.07	15.8 days Standard Deviation 9.91

SECONDARY outcome

Timeframe: Day 1-day 28

Population: Intent to treat in patients who were not taking any supplemental oxygen at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Number of patients with new supplemental oxygen use

Outcome measures

Measure	Standard of Care + Infliximab n=24 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=20 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=25 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=20 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=16 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=13 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With New Supplemental Oxygen Use	13 Participants	5 Participants	11 Participants	6 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 to day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Days alive and free of non-invasive ventilation/ high flow oxygen

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen	20.7 days Standard Deviation 10.20	19.5 days Standard Deviation 11.02	20.3 days Standard Deviation 10.16	19.3 days Standard Deviation 11.12	19.4 days Standard Deviation 11.02	20.1 days Standard Deviation 10.47

SECONDARY outcome

Timeframe: Day 1-day 28

Population: Intent to treat in patients who were not taking any supplemental or non-invasive/high flow oxygen at baseline. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Number of patients with new non-invasive ventilation/high flow oxygen use

Outcome measures

Measure	Standard of Care + Infliximab n=299 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=299 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=301 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=299 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=201 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=204 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use	68 Participants	89 Participants	81 Participants	92 Participants	64 Participants	67 Participants

SECONDARY outcome

Timeframe: Day 1 to day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Days alive and free of invasive mechanical ventilation or ECMO

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO	23.4 days Standard Deviation 8.96	22.6 days Standard Deviation 9.75	23.4 days Standard Deviation 9.16	22.6 days Standard Deviation 9.72	22.4 days Standard Deviation 9.95	23.2 days Standard Deviation 9.17

SECONDARY outcome

Timeframe: Day 1 to day 28

Population: Intent to treat in patients that were not receiving ECMO at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Number of patients with new mechanical ventilation or ECMO use

Outcome measures

Measure	Standard of Care + Infliximab n=473 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=477 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=476 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=474 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=331 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=332 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With New Mechanical Ventilation or ECMO Use	70 Participants	76 Participants	71 Participants	77 Participants	62 Participants	55 Participants

SECONDARY outcome

Timeframe: Through day 28

Population: Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Days alive and out of the hospital

Outcome measures

Measure	Standard of Care + Infliximab n=531 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=530 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=524 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=525 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=360 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=363 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Duration (Days) Alive and Out of the Hospital	14.7 days Standard Deviation 9.42	13.8 days Standard Deviation 9.74	14.1 days Standard Deviation 9.75	13.7 days Standard Deviation 9.86	14.2 days Standard Deviation 9.56	14.3 days Standard Deviation 9.56

SECONDARY outcome

Timeframe: Day 28

Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Cumulative Incidence of SAEs through day 28

Outcome measures

Measure	Standard of Care + Infliximab n=517 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=516 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=509 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=355 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=354 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With SAEs Through Day 28	112 Participants	124 Participants	116 Participants	131 Participants	95 Participants	80 Participants

SECONDARY outcome

Timeframe: Day 28

Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Cumulative incidence of adverse events of grade 3 and 4

Outcome measures

Measure	Standard of Care + Infliximab n=517 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=516 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=509 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=355 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=354 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With Grade 3 and 4 Adverse Events	137 Participants	126 Participants	124 Participants	132 Participants	101 Participants	94 Participants

SECONDARY outcome

Timeframe: Day 1-28

Population: Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.

Number of patients with adverse events (serious and non serious) leading to dose modification

Outcome measures

Measure	Standard of Care + Infliximab n=517 Participants infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=516 Participants infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=509 Participants abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 Participants abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=355 Participants cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021	Standard of Care + Cenicriviroc Matching Placebo n=354 Participants cenicriviroc matching placebo \[tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021
Number of Patients With Adverse Events Leading to Dose Modification	4 Participants	7 Participants	4 Participants	7 Participants	34 Participants	7 Participants

Adverse Events

Standard of Care + Infliximab

Serious events: 125 serious events

Other events: 18 other events

Deaths: 65 deaths

Standard of Care + Infliximab Matching Placebo

Serious events: 130 serious events

Other events: 18 other events

Deaths: 85 deaths

Standard of Care + Abatacept

Serious events: 128 serious events

Other events: 24 other events

Deaths: 74 deaths

Standard of Care + Abatacept Matching Placebo

Serious events: 136 serious events

Other events: 18 other events

Deaths: 87 deaths

Standard of Care + Cenicriviroc

Serious events: 102 serious events

Other events: 13 other events

Deaths: 64 deaths

Standard of Care + Cenicriviroc Matching Placebo

Serious events: 84 serious events

Other events: 13 other events

Deaths: 49 deaths

Serious adverse events

Measure	Standard of Care + Infliximab n=517 participants at risk infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=516 participants at risk infliximab matching placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=509 participants at risk abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 participants at risk abatacept matching placebo (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=355 participants at risk cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. cenicriviroc: study drug Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug	Standard of Care + Cenicriviroc Matching Placebo n=354 participants at risk cenicriviroc matching placebo \[tablet, Day 1/Loading Dose: 2 tabs in morning and 1 evening Day 2 - 29/Maintenance Dose: BID through Day 29\]. Remdesivir: Standard of Care
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.1% 11/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 7/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.5% 13/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 5/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 5/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.4% 7/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.39% 2/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.39% 2/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 5/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.00% 0/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Infections and infestations Septic shock	1.7% 9/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 7/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.8% 14/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.6% 8/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.7% 6/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 5/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.2% 6/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.4% 7/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.85% 3/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.1% 4/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.19% 1/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.39% 2/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.1% 4/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.00% 0/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Infections and infestations Pneumonia bacterial	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.97% 5/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.98% 5/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.85% 3/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.85% 3/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Infections and infestations Sepsis	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.58% 3/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.98% 5/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.56% 2/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.56% 2/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Vascular disorders Deep Vein Thrombosis	0.97% 5/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.58% 3/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.20% 1/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.59% 3/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.00% 0/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.85% 3/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Cardiac disorders Cardiac arrest	1.4% 7/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.39% 2/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.2% 6/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.39% 2/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.7% 6/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.28% 1/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.19% 1/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.1% 11/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	0.98% 5/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.2% 11/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.3% 8/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.0% 7/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	7.0% 36/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	7.0% 36/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	6.9% 35/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	7.6% 39/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	10.4% 37/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	8.5% 30/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Infections and infestations Pneumonia	1.5% 8/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.5% 13/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.1% 16/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.2% 11/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.9% 14/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.7% 6/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Renal and urinary disorders Acute kidney injury	2.1% 11/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.7% 9/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.6% 8/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.6% 8/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	2.0% 7/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	1.1% 4/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	6.2% 32/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	5.6% 29/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	4.5% 23/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	6.3% 32/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	5.9% 21/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	4.8% 17/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.

Other adverse events

Measure	Standard of Care + Infliximab n=517 participants at risk infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care	Standard of Care + Infliximab Matching Placebo n=516 participants at risk infliximab matching placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care	Standard of Care + Abatacept n=509 participants at risk abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care	Standard of Care + Abatacept Matching Placebo n=510 participants at risk abatacept matching placebo (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care	Standard of Care + Cenicriviroc n=355 participants at risk cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. cenicriviroc: study drug Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug	Standard of Care + Cenicriviroc Matching Placebo n=354 participants at risk cenicriviroc matching placebo \[tablet, Day 1/Loading Dose: 2 tabs in morning and 1 evening Day 2 - 29/Maintenance Dose: BID through Day 29\]. Remdesivir: Standard of Care
Infections and infestations Pneumonia	3.5% 18/517 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.5% 18/516 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	4.7% 24/509 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.5% 18/510 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.7% 13/355 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.	3.7% 13/354 • Day 1-60 Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.

Additional Information

William G. Powderly MD

Washington University in St. Louis

Phone: 314-454-8276

Email: wpowderly@wustl.edu

Results disclosure agreements

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

Restriction type: GT60