Trial Outcomes & Findings for ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19 (NCT NCT04583956)

NCT ID: NCT04583956

Last Updated: 2023-05-16

Results Overview

The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 214 participants
• Primary outcome timeframe: Day 8
• Results posted on: 2023-05-16

Participant Flow

Participants were male and non-pregnant female adults =18 years of age or older and hospitalized with COVID-19. Participants were enrolled between 23OCT2020 and 13JUL2021.

Participant milestones

Measure	Remdesivir + Risankizumab 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1. Remdesivir: Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524. Risankizumab: Risankizumab is a humanized immunoglobulin (Ig) G1 antagonistic monoclonal antibody (mAb) directed against the p19 subunit of the human cytokine interleukin-23. Risankizumab is formulated in a buffer of 4.4 mM disodium succinate hexahydrate/succinic acid, 225 mM sorbitol, 0.2 mg/mL polysorbate 20, and WFI in a 6R vial.	Remdesivir + Placebo 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1. Placebo: Risankizumab placebo will be given at an equal volume at the same schedule. Remdesivir: Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
Overall Study STARTED	104	110
Overall Study Included in Modified Intention-to-treat (mITT) Population	100	107
Overall Study COMPLETED	83	85
Overall Study NOT COMPLETED	21	25

Reasons for withdrawal

Measure	Remdesivir + Risankizumab 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1. Remdesivir: Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524. Risankizumab: Risankizumab is a humanized immunoglobulin (Ig) G1 antagonistic monoclonal antibody (mAb) directed against the p19 subunit of the human cytokine interleukin-23. Risankizumab is formulated in a buffer of 4.4 mM disodium succinate hexahydrate/succinic acid, 225 mM sorbitol, 0.2 mg/mL polysorbate 20, and WFI in a 6R vial.	Remdesivir + Placebo 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1. Placebo: Risankizumab placebo will be given at an equal volume at the same schedule. Remdesivir: Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
Overall Study Death	9	11
Overall Study Lost to Follow-up	7	9
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	0	2
Overall Study Randomized but not dosed	2	3
Overall Study Withdrawal of consent before product administration	1	0

Baseline Characteristics

ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19

Baseline characteristics by cohort

Measure	Remdesivir + Risankizumab n=104 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=110 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	78 Participants n=7 Participants	164 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	32 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	54.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	57.5 years STANDARD_DEVIATION 13.1 • n=7 Participants	56.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	52 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	58 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=5 Participants	89 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	67 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants	110 participants n=7 Participants	214 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Not hospitalized, no new or increased limitations on activities	15 Participants	21 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP	36 Participants	36 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care	0 Participants	0 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Hospitalized, not req new or increased supplemental O2 - req ongoing medical care	6 Participants	3 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Hospitalized, requiring new or increased supplemental O2	17 Participants	16 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices	13 Participants	19 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Hospitalized, on invasive mechanical ventilation or ECMO	11 Participants	9 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Death	2 Participants	2 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Ordinal scale categories include 8) Death and 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO). Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Results are reported as Kaplan Meier estimates.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories Through Day 29	0.87 Proportion of participants Interval 0.78 to 0.92	0.88 Proportion of participants Interval 0.8 to 0.93

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the clinical status ordinal scale (and does not return to a score of = 4 up to and including Study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Time to Sustained Recovery	7.0 days Interval 5.0 to 8.0	6.0 days Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: Day 15

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Death	6 Participants	3 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Not hospitalized, no new or increased limitations on activities	31 Participants	37 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP	46 Participants	42 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care	0 Participants	0 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Hospitalized, not req new or increased supplemental O2 - req ongoing medical care	1 Participants	2 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Hospitalized, requiring new or increased supplemental O2	10 Participants	10 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices	2 Participants	4 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 Hospitalized, on invasive mechanical ventilation or ECMO	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Not hospitalized, no new or increased limitations on activities	46 Participants	50 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP	43 Participants	38 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care	0 Participants	0 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Hospitalized, not req new or increased supplemental O2 - req ongoing medical care	0 Participants	1 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Hospitalized, requiring new or increased supplemental O2	0 Participants	3 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices	0 Participants	4 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Hospitalized, on invasive mechanical ventilation or ECMO	4 Participants	4 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 Death	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in C-Reactive Protein (CRP) Day 3	-49.471 milligrams/liter (mg/L) Standard Deviation 68.217	-37.344 milligrams/liter (mg/L) Standard Deviation 64.622
Change From Baseline in C-Reactive Protein (CRP) Day 5	-64.340 milligrams/liter (mg/L) Standard Deviation 77.430	-51.216 milligrams/liter (mg/L) Standard Deviation 80.230
Change From Baseline in C-Reactive Protein (CRP) Day 8	-62.578 milligrams/liter (mg/L) Standard Deviation 82.042	-58.094 milligrams/liter (mg/L) Standard Deviation 113.351
Change From Baseline in C-Reactive Protein (CRP) Day 11	-17.365 milligrams/liter (mg/L) Standard Deviation 138.044	-49.828 milligrams/liter (mg/L) Standard Deviation 143.271
Change From Baseline in C-Reactive Protein (CRP) Day 15	-66.453 milligrams/liter (mg/L) Standard Deviation 76.258	-58.816 milligrams/liter (mg/L) Standard Deviation 70.797
Change From Baseline in C-Reactive Protein (CRP) Day 29	-77.527 milligrams/liter (mg/L) Standard Deviation 69.087	-68.496 milligrams/liter (mg/L) Standard Deviation 74.662

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Ferritin Day 3	-187.123 micrograms/liter (ug/L) Standard Deviation 437.096	-145.201 micrograms/liter (ug/L) Standard Deviation 562.150
Change From Baseline in Ferritin Day 5	-326.691 micrograms/liter (ug/L) Standard Deviation 610.633	-37.041 micrograms/liter (ug/L) Standard Deviation 1956.100
Change From Baseline in Ferritin Day 8	-252.804 micrograms/liter (ug/L) Standard Deviation 754.932	-236.725 micrograms/liter (ug/L) Standard Deviation 800.878
Change From Baseline in Ferritin Day 11	-90.829 micrograms/liter (ug/L) Standard Deviation 648.972	-371.682 micrograms/liter (ug/L) Standard Deviation 628.049
Change From Baseline in Ferritin Day 15	-305.970 micrograms/liter (ug/L) Standard Deviation 941.210	-317.063 micrograms/liter (ug/L) Standard Deviation 828.814
Change From Baseline in Ferritin Day 29	-520.237 micrograms/liter (ug/L) Standard Deviation 476.899	-762.394 micrograms/liter (ug/L) Standard Deviation 1056.614

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in D-dimer Day 3	-1642.4 ug/L fibrinogen equivalent units (FEU) Standard Deviation 12710.1	-38.8 ug/L fibrinogen equivalent units (FEU) Standard Deviation 3315.6
Change From Baseline in D-dimer Day 5	-914.1 ug/L fibrinogen equivalent units (FEU) Standard Deviation 21635.7	-129.3 ug/L fibrinogen equivalent units (FEU) Standard Deviation 4104.4
Change From Baseline in D-dimer Day 8	-4124.4 ug/L fibrinogen equivalent units (FEU) Standard Deviation 23690.0	-38.9 ug/L fibrinogen equivalent units (FEU) Standard Deviation 19399.8
Change From Baseline in D-dimer Day 11	-10670.7 ug/L fibrinogen equivalent units (FEU) Standard Deviation 34100.4	-741.2 ug/L fibrinogen equivalent units (FEU) Standard Deviation 5094.4
Change From Baseline in D-dimer Day 15	-8990.9 ug/L fibrinogen equivalent units (FEU) Standard Deviation 28348.8	907.1 ug/L fibrinogen equivalent units (FEU) Standard Deviation 8625.0
Change From Baseline in D-dimer Day 29	-6516.8 ug/L fibrinogen equivalent units (FEU) Standard Deviation 20705.8	-471.8 ug/L fibrinogen equivalent units (FEU) Standard Deviation 2401.0

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Fibrinogen Day 3	-89.7 milligrams/deciliter (mg/dL) Standard Deviation 124.9	-78.6 milligrams/deciliter (mg/dL) Standard Deviation 109.6
Change From Baseline in Fibrinogen Day 5	-109.0 milligrams/deciliter (mg/dL) Standard Deviation 169.3	-108.8 milligrams/deciliter (mg/dL) Standard Deviation 165.1
Change From Baseline in Fibrinogen Day 8	-100.5 milligrams/deciliter (mg/dL) Standard Deviation 218.2	-121.0 milligrams/deciliter (mg/dL) Standard Deviation 225.5
Change From Baseline in Fibrinogen Day 11	61.1 milligrams/deciliter (mg/dL) Standard Deviation 319.3	-33.2 milligrams/deciliter (mg/dL) Standard Deviation 282.7
Change From Baseline in Fibrinogen Day 15	-37.6 milligrams/deciliter (mg/dL) Standard Deviation 235.1	-26.3 milligrams/deciliter (mg/dL) Standard Deviation 181.6
Change From Baseline in Fibrinogen Day 29	-99.3 milligrams/deciliter (mg/dL) Standard Deviation 208.1	-102.0 milligrams/deciliter (mg/dL) Standard Deviation 185.6

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Alanine Aminotransferase (ALT) Day 3	6.1 U/L Standard Deviation 25.8	9.6 U/L Standard Deviation 43.5
Change From Baseline in Alanine Aminotransferase (ALT) Day 5	9.4 U/L Standard Deviation 34.7	64.0 U/L Standard Deviation 290.4
Change From Baseline in Alanine Aminotransferase (ALT) Day 8	6.1 U/L Standard Deviation 48.3	33.9 U/L Standard Deviation 168.1
Change From Baseline in Alanine Aminotransferase (ALT) Day 11	5.3 U/L Standard Deviation 55.7	21.5 U/L Standard Deviation 117.7
Change From Baseline in Alanine Aminotransferase (ALT) Day 15	7.6 U/L Standard Deviation 45.9	-3.3 U/L Standard Deviation 55.3
Change From Baseline in Alanine Aminotransferase (ALT) Day 29	-0.1 U/L Standard Deviation 31.6	-19.3 U/L Standard Deviation 62.1

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Aspartate Transaminase (AST) Day 3	-1.4 U/L Standard Deviation 39.9	-5.0 U/L Standard Deviation 46.4
Change From Baseline in Aspartate Transaminase (AST) Day 5	-8.4 U/L Standard Deviation 36.6	44.2 U/L Standard Deviation 432.3
Change From Baseline in Aspartate Transaminase (AST) Day 8	-16.7 U/L Standard Deviation 37.6	34.9 U/L Standard Deviation 404.0
Change From Baseline in Aspartate Transaminase (AST) Day 11	-8.9 U/L Standard Deviation 45.1	39.4 U/L Standard Deviation 318.0
Change From Baseline in Aspartate Transaminase (AST) Day 15	-13.8 U/L Standard Deviation 34.6	-16.9 U/L Standard Deviation 33.0
Change From Baseline in Aspartate Transaminase (AST) Day 29	-13.1 U/L Standard Deviation 22.4	-28.2 U/L Standard Deviation 37.3

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Hemoglobin Day 3	-0.199 g/dL Standard Deviation 0.785	-0.035 g/dL Standard Deviation 0.893
Change From Baseline in Hemoglobin Day 5	-0.485 g/dL Standard Deviation 1.142	-0.074 g/dL Standard Deviation 1.202
Change From Baseline in Hemoglobin Day 8	-0.461 g/dL Standard Deviation 1.434	-0.323 g/dL Standard Deviation 1.460
Change From Baseline in Hemoglobin Day 11	-1.079 g/dL Standard Deviation 1.997	-0.714 g/dL Standard Deviation 1.722
Change From Baseline in Hemoglobin Day 15	-0.817 g/dL Standard Deviation 1.702	-0.805 g/dL Standard Deviation 1.929
Change From Baseline in Hemoglobin Day 29	-0.524 g/dL Standard Deviation 1.989	-0.642 g/dL Standard Deviation 1.867

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Creatinine Day 3	0.000 mg/dL Standard Deviation 0.332	-0.858 mg/dL Standard Deviation 8.777
Change From Baseline in Creatinine Day 5	-0.041 mg/dL Standard Deviation 0.306	-1.091 mg/dL Standard Deviation 10.138
Change From Baseline in Creatinine Day 8	-0.023 mg/dL Standard Deviation 0.281	-1.993 mg/dL Standard Deviation 13.677
Change From Baseline in Creatinine Day 11	-0.127 mg/dL Standard Deviation 0.371	-3.044 mg/dL Standard Deviation 16.911
Change From Baseline in Creatinine Day 15	-0.096 mg/dL Standard Deviation 0.347	0.362 mg/dL Standard Deviation 1.172
Change From Baseline in Creatinine Day 29	-0.023 mg/dL Standard Deviation 0.249	0.211 mg/dL Standard Deviation 1.148

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in International Normalized Ratio (INR) Day 3	0.063 Ratio Standard Deviation 0.174	0.069 Ratio Standard Deviation 0.257
Change From Baseline in International Normalized Ratio (INR) Day 5	0.103 Ratio Standard Deviation 0.257	0.174 Ratio Standard Deviation 0.682
Change From Baseline in International Normalized Ratio (INR) Day 8	0.038 Ratio Standard Deviation 0.206	0.277 Ratio Standard Deviation 1.580
Change From Baseline in International Normalized Ratio (INR) Day 11	0.137 Ratio Standard Deviation 0.525	0.015 Ratio Standard Deviation 0.249
Change From Baseline in International Normalized Ratio (INR) Day 15	-0.092 Ratio Standard Deviation 0.238	-0.077 Ratio Standard Deviation 0.164
Change From Baseline in International Normalized Ratio (INR) Day 29	-0.129 Ratio Standard Deviation 0.185	-0.075 Ratio Standard Deviation 0.141

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Platelets Day 3	59.49 10^9 cells/L Standard Deviation 48.59	50.45 10^9 cells/L Standard Deviation 60.91
Change From Baseline in Platelets Day 5	81.22 10^9 cells/L Standard Deviation 65.53	76.17 10^9 cells/L Standard Deviation 80.11
Change From Baseline in Platelets Day 8	96.73 10^9 cells/L Standard Deviation 106.11	71.59 10^9 cells/L Standard Deviation 139.53
Change From Baseline in Platelets Day 11	54.95 10^9 cells/L Standard Deviation 109.38	-1.68 10^9 cells/L Standard Deviation 117.94
Change From Baseline in Platelets Day 15	-16.90 10^9 cells/L Standard Deviation 110.76	-24.19 10^9 cells/L Standard Deviation 120.42
Change From Baseline in Platelets Day 29	27.42 10^9 cells/L Standard Deviation 128.22	45.97 10^9 cells/L Standard Deviation 111.20

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Bilirubin Day 3	-0.033 mg/dL Standard Deviation 0.201	-0.024 mg/dL Standard Deviation 0.152
Change From Baseline in Bilirubin Day 5	-0.020 mg/dL Standard Deviation 0.267	0.026 mg/dL Standard Deviation 0.249
Change From Baseline in Bilirubin Day 8	0.016 mg/dL Standard Deviation 0.336	0.076 mg/dL Standard Deviation 0.343
Change From Baseline in Bilirubin Day 11	0.153 mg/dL Standard Deviation 0.467	0.148 mg/dL Standard Deviation 0.581
Change From Baseline in Bilirubin Day 15	0.157 mg/dL Standard Deviation 0.494	0.131 mg/dL Standard Deviation 0.430
Change From Baseline in Bilirubin Day 29	-0.033 mg/dL Standard Deviation 0.291	-0.091 mg/dL Standard Deviation 0.223

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in White Blood Cell (WBC) Day 3	1.672 10^9 cells/L Standard Deviation 3.589	1.432 10^9 cells/L Standard Deviation 3.453
Change From Baseline in White Blood Cell (WBC) Day 5	2.484 10^9 cells/L Standard Deviation 4.053	2.437 10^9 cells/L Standard Deviation 4.231
Change From Baseline in White Blood Cell (WBC) Day 8	3.726 10^9 cells/L Standard Deviation 3.781	5.298 10^9 cells/L Standard Deviation 6.390
Change From Baseline in White Blood Cell (WBC) Day 11	4.852 10^9 cells/L Standard Deviation 6.784	4.545 10^9 cells/L Standard Deviation 7.772
Change From Baseline in White Blood Cell (WBC) Day 15	1.770 10^9 cells/L Standard Deviation 5.869	1.663 10^9 cells/L Standard Deviation 5.882
Change From Baseline in White Blood Cell (WBC) Day 29	-0.801 10^9 cells/L Standard Deviation 4.355	-2.016 10^9 cells/L Standard Deviation 4.645

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Neutrophils Day 3	1.0297 10^9 cells/L Standard Deviation 2.6919	0.9628 10^9 cells/L Standard Deviation 3.0963
Change From Baseline in Neutrophils Day 5	1.1050 10^9 cells/L Standard Deviation 2.6733	1.3373 10^9 cells/L Standard Deviation 3.3580
Change From Baseline in Neutrophils Day 8	2.8066 10^9 cells/L Standard Deviation 3.1523	4.1114 10^9 cells/L Standard Deviation 5.5771
Change From Baseline in Neutrophils Day 11	4.0192 10^9 cells/L Standard Deviation 5.5099	2.4704 10^9 cells/L Standard Deviation 4.7446
Change From Baseline in Neutrophils Day 15	-0.5410 10^9 cells/L Standard Deviation 2.9101	0.1833 10^9 cells/L Standard Deviation 3.5524
Change From Baseline in Neutrophils Day 29	-1.8493 10^9 cells/L Standard Deviation 3.3028	-2.6216 10^9 cells/L Standard Deviation 3.8118

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Eosinophils Day 3	0.0009 10^9 cells/L Standard Deviation 0.0350	0.0062 10^9 cells/L Standard Deviation 0.0557
Change From Baseline in Eosinophils Day 5	0.0297 10^9 cells/L Standard Deviation 0.0615	0.0221 10^9 cells/L Standard Deviation 0.0699
Change From Baseline in Eosinophils Day 8	0.0810 10^9 cells/L Standard Deviation 0.0969	0.0259 10^9 cells/L Standard Deviation 0.0717
Change From Baseline in Eosinophils Day 11	0.1282 10^9 cells/L Standard Deviation 0.1387	0.0814 10^9 cells/L Standard Deviation 0.0953
Change From Baseline in Eosinophils Day 15	0.0924 10^9 cells/L Standard Deviation 0.0902	0.1761 10^9 cells/L Standard Deviation 0.1577
Change From Baseline in Eosinophils Day 29	0.1256 10^9 cells/L Standard Deviation 0.0955	0.3421 10^9 cells/L Standard Deviation 0.3291

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Basophils Day 3	0.0101 10^9 cells/L Standard Deviation 0.0561	0.0052 10^9 cells/L Standard Deviation 0.0286
Change From Baseline in Basophils Day 5	0.0038 10^9 cells/L Standard Deviation 0.0315	0.0039 10^9 cells/L Standard Deviation 0.0275
Change From Baseline in Basophils Day 8	0.0455 10^9 cells/L Standard Deviation 0.2018	0.0061 10^9 cells/L Standard Deviation 0.0308
Change From Baseline in Basophils Day 11	0.0291 10^9 cells/L Standard Deviation 0.0288	0.0123 10^9 cells/L Standard Deviation 0.0357
Change From Baseline in Basophils Day 15	0.0202 10^9 cells/L Standard Deviation 0.0348	0.0254 10^9 cells/L Standard Deviation 0.0307
Change From Baseline in Basophils Day 29	0.0262 10^9 cells/L Standard Deviation 0.0343	0.0425 10^9 cells/L Standard Deviation 0.0387

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Lymphocytes Day 3	0.2788 10^9 cells/L Standard Deviation 0.4560	0.3009 10^9 cells/L Standard Deviation 0.5398
Change From Baseline in Lymphocytes Day 5	0.4256 10^9 cells/L Standard Deviation 0.6067	0.4233 10^9 cells/L Standard Deviation 0.7375
Change From Baseline in Lymphocytes Day 8	0.3956 10^9 cells/L Standard Deviation 0.6478	0.2612 10^9 cells/L Standard Deviation 0.6765
Change From Baseline in Lymphocytes Day 11	0.4431 10^9 cells/L Standard Deviation 0.5793	0.2932 10^9 cells/L Standard Deviation 0.6446
Change From Baseline in Lymphocytes Day 15	0.7937 10^9 cells/L Standard Deviation 0.6577	0.6096 10^9 cells/L Standard Deviation 0.7233
Change From Baseline in Lymphocytes Day 29	0.8309 10^9 cells/L Standard Deviation 0.5085	0.7879 10^9 cells/L Standard Deviation 0.5810

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.

Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Change From Baseline in Monocytes Day 3	0.1697 10^9 cells/L Standard Deviation 0.3201	0.1023 10^9 cells/L Standard Deviation 0.5020
Change From Baseline in Monocytes Day 5	0.2023 10^9 cells/L Standard Deviation 0.3254	0.1318 10^9 cells/L Standard Deviation 0.5708
Change From Baseline in Monocytes Day 8	0.3398 10^9 cells/L Standard Deviation 0.4427	0.1135 10^9 cells/L Standard Deviation 0.7707
Change From Baseline in Monocytes Day 11	0.2450 10^9 cells/L Standard Deviation 0.2887	0.1835 10^9 cells/L Standard Deviation 0.8518
Change From Baseline in Monocytes Day 15	0.1694 10^9 cells/L Standard Deviation 0.3182	0.1407 10^9 cells/L Standard Deviation 0.6706
Change From Baseline in Monocytes Day 29	-0.0175 10^9 cells/L Standard Deviation 0.2896	-0.0232 10^9 cells/L Standard Deviation 0.7208

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.

Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)	42 Participants	46 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.

An SAE is defined as an AE or suspected adverse reaction that is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Reporting Serious Adverse Events (SAEs)	24 Participants	26 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.

Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants Who Discontinued or Temporarily Suspended Study Treatment	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Duration of Hospitalization Hospitalized for COVID-19	6.0 days Interval 4.0 to 11.5	6.0 days Interval 4.0 to 13.0
Duration of Hospitalization Hospitalized for Any Reason	6.0 days Interval 4.0 to 11.5	6.0 days Interval 4.0 to 14.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.

Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died.

Outcome measures

Measure	Remdesivir + Risankizumab n=97 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=104 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Days of New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use	0.0 days Interval 0.0 to 0.0	0.0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Days of Non-invasive Ventilation/High Flow Oxygen Use	0.0 days Interval 0.0 to 6.5	0.0 days Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline were included in the analysis.

Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.

Outcome measures

Measure	Remdesivir + Risankizumab n=69 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=79 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Days of New Non-invasive Ventilation/High Flow Oxygen Use	0.0 days Interval 0.0 to 0.0	0.0 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.

New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study.

Outcome measures

Measure	Remdesivir + Risankizumab n=97 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=104 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline were included in the analysis.

New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.

Outcome measures

Measure	Remdesivir + Risankizumab n=69 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=79 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use	10 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1, 3, 5, 11, 15, 22, 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4)Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Mean Change in Ordinal Scale Day 3	0.0 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.4
Mean Change in Ordinal Scale Day 5	-0.5 units on a scale Standard Deviation 1.3	-0.4 units on a scale Standard Deviation 1.2
Mean Change in Ordinal Scale Day 8	-1.7 units on a scale Standard Deviation 1.9	-1.7 units on a scale Standard Deviation 2.0
Mean Change in Ordinal Scale Day 11	-2.2 units on a scale Standard Deviation 1.9	-2.1 units on a scale Standard Deviation 2.0
Mean Change in Ordinal Scale Day 15	-2.7 units on a scale Standard Deviation 1.9	-2.6 units on a scale Standard Deviation 1.9
Mean Change in Ordinal Scale Day 22	-3.1 units on a scale Standard Deviation 1.9	-2.8 units on a scale Standard Deviation 1.8
Mean Change in Ordinal Scale Day 29	-3.2 units on a scale Standard Deviation 1.9	-2.9 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Ordinal scale categories include 8) Death and 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO). Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29	0.89 Proportion of participants Interval 0.81 to 0.94	0.90 Proportion of participants Interval 0.83 to 0.95

SECONDARY outcome

Timeframe: Day 1 through Day 15

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.

The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
14-day Participant Mortality	0.06 Proportion of participants Interval 0.03 to 0.13	0.03 Proportion of participants Interval 0.01 to 0.08

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.

The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
28-day Participant Mortality	0.07 Proportion of participants Interval 0.04 to 0.15	0.08 Proportion of participants Interval 0.04 to 0.15

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.

The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
59-day Participant Mortality	0.09 Proportion of participants Interval 0.05 to 0.17	0.11 Proportion of participants Interval 0.06 to 0.19

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Days of Supplemental Oxygen Use	11.0 days Interval 4.0 to 28.0	11.0 days Interval 5.0 to 28.0

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Time to an Improvement of One Category From Baseline Using an Ordinal Scale	6.0 days Interval 6.0 to 7.0	7.0 days Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale	12.0 days Interval 10.0 to 13.0	13.0 days Interval 9.0 to 13.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.

The time death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Time to Death	NA days Median, lower and upper confidence intervals were not reached due to insufficient number of participants with events (deaths).	NA days Median, lower and upper confidence intervals were not reached due to insufficient number of participants with events (deaths).

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.

Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died.

Outcome measures

Measure	Remdesivir + Risankizumab n=100 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 Participants 200-mg IV remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use	0.0 days Interval 0.0 to 0.0	0.0 days Interval 0.0 to 0.0

Adverse Events

Remdesivir + Risankizumab

Serious events: 24 serious events

Other events: 24 other events

Deaths: 9 deaths

Remdesivir + Placebo

Serious events: 26 serious events

Other events: 22 other events

Deaths: 11 deaths

Serious adverse events

Measure	Remdesivir + Risankizumab n=100 participants at risk 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 participants at risk 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Blood and lymphatic system disorders Anaemia	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Cardiac disorders Acute left ventricular failure	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Cardiac disorders Acute myocardial infarction	3.0% 3/100 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Cardiac disorders Atrial fibrillation	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.9% 2/107 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Cardiac disorders Cardiac failure congestive	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Cardiac disorders Tachycardia	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
General disorders Incarcerated hernia	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
General disorders Multiple organ dysfunction syndrome	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
General disorders Obstruction	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Bacterial sepsis	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations COVID-19 pneumonia	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Pneumonia	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Pneumonia bacterial	3.0% 3/100 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	2.8% 3/107 • Number of events 4 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Pneumonia fungal	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Sepsis	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.9% 2/107 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Infections and infestations Septic shock	3.0% 3/100 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	3.7% 4/107 • Number of events 5 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Injury, poisoning and procedural complications Chillblains	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Aspartate aminotransferase increased	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Body temperature decreased	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Haemoglobin decreased	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Lymphocyte count decreased	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Nervous system disorders Cerebrovascular accident	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Nervous system disorders Encephalopathy	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Nervous system disorders Seizure	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Renal and urinary disorders Acute kidney injury	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	2.8% 3/107 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Renal and urinary disorders Renal Failure	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.9% 2/107 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	5.6% 6/107 • Number of events 7 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 2/100 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.9% 2/107 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	1.9% 2/107 • Number of events 2 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 10/100 • Number of events 10 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	7.5% 8/107 • Number of events 9 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Surgical and medical procedures Extubation	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Surgical and medical procedures Gastrectomy	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Vascular disorders Deep vein thrombosis	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Vascular disorders Hypovolaemic shock	0.00% 0/100 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.93% 1/107 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Vascular disorders Shock	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	0.00% 0/107 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.

Other adverse events

Measure	Remdesivir + Risankizumab n=100 participants at risk 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab infusion (300-mg x 4 vials) once on Day 1.	Remdesivir + Placebo n=107 participants at risk 200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 1200-mg IV risankizumab placebo infusion (300-mg x 4 vials) once on Day 1.
Investigations Glomerular filtration rate decreased	8.0% 8/100 • Number of events 10 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	4.7% 5/107 • Number of events 6 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Lymphocyte count decreased	6.0% 6/100 • Number of events 8 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	5.6% 6/107 • Number of events 6 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Investigations Oxygen saturation decreased	5.0% 5/100 • Number of events 5 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	2.8% 3/107 • Number of events 3 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Renal and urinary disorders Acute kidney injury	1.0% 1/100 • Number of events 1 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	5.6% 6/107 • Number of events 6 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Vascular disorders Hypertension	4.0% 4/100 • Number of events 4 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.	9.3% 10/107 • Number of events 17 • Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.

Additional Information

John Beigel, MD

NIAID

Phone: 3014519881

Email: jbeigel@niaid.nih.gov

Results disclosure agreements

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