Trial Outcomes & Findings for ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 (NCT NCT04583969)

NCT ID: NCT04583969

Last Updated: 2023-06-05

Results Overview

Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. 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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 527 participants
• Primary outcome timeframe: Day 1 through Day 29
• Results posted on: 2023-06-05

Participant Flow

Participants were male and non-pregnant female adults who were 18 years of age or older and hospitalized with COVID-19. Participants were enrolled between 23OCT2020 and 09JAN2022.

Participant milestones

Measure	Remdesivir + Lenzilumab 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Overall Study STARTED	272	255
Overall Study COMPLETED	215	196
Overall Study NOT COMPLETED	57	59

Reasons for withdrawal

Measure	Remdesivir + Lenzilumab 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Overall Study Death	31	38
Overall Study Lost to Follow-up	16	13
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	3	3
Overall Study RANDOMIZED BUT NOT DOSED	2	4
Overall Study TECHNICAL DIFFICULTIES, NOT ENOUGH STUDY DRUG ON SITE	1	0
Overall Study RECEIVED PROHIBITED CONCOMITANT THERAPY	1	0
Overall Study WITHDRAWAL OF CONSENT BEFORE PRODUCT ADMINISTRATION	1	1
Overall Study TRANSITION TO COMFORT CARE/HOSPICE	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.	Total n=527 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	204 Participants n=5 Participants	186 Participants n=7 Participants	390 Participants n=5 Participants
Age, Categorical >=65 years	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Age, Continuous	55.7 years STANDARD_DEVIATION 13.9 • n=5 Participants	55.1 years STANDARD_DEVIATION 14.3 • n=7 Participants	55.4 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	88 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	167 Participants n=7 Participants	348 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	54 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	229 Participants n=5 Participants	200 Participants n=7 Participants	429 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) White	194 Participants n=5 Participants	175 Participants n=7 Participants	369 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment South Korea	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment United States	268 participants n=5 Participants	249 participants n=7 Participants	517 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 29

Population: The primary subgroup population includes all randomized participants with a baseline ordinal score of 5 or 6, CRP\<150 mg/L at baseline, and age\<85 years.

Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. 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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.

Outcome measures

Measure	Remdesivir + Lenzilumab n=200 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=199 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Baseline Ordinal Score of 5 or 6, C-reactive Protein (CRP)<150mg/L and Age <85 Years	0.85 Proportion of participants Interval 0.8 to 0.9	0.84 Proportion of participants Interval 0.78 to 0.89

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants.

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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.

Outcome measures

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score	0.83 Proportion of participants Interval 0.78 to 0.87	0.80 Proportion of participants Interval 0.75 to 0.85

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The primary subgroup population includes all randomized participants with a baseline ordinal score of 5 or 6, CRP\<150 mg/L at baseline, and age\<85 years.

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, Continuous Positive Airway Pressure (CPAP), or Bilevel Positive Airway Pressure (BiPAP); 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.

Outcome measures

Measure	Remdesivir + Lenzilumab n=200 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=199 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Time to Sustained Recovery in Participants With a Baseline Ordinal Score of 5 or 6, CRP<150mg/L and Age <85 Years	8.0 days Interval 6.0 to 9.0	7.0 days Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Time to Sustained Recovery in Participants With Any Baseline Ordinal Score	8.0 days Interval 7.0 to 9.0	8.0 days Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: Day 8

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death

Outcome measures

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 1. Not hospitalized, no new or increased limitations on activities	36 Participants	38 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 2. Not. hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP	71 Participants	69 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care	3 Participants	0 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care	8 Participants	8 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 5. Hospitalized, requiring new or increased supplemental O2	65 Participants	50 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 6. Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices	52 Participants	58 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 7. Hospitalized, on invasive mechanical ventilation or ECMO	31 Participants	26 Participants
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 8. Death	6 Participants	6 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in C-Reactive Protein (CRP) Day 3	-56.006 mg/L Standard Deviation 111.701	-41.259 mg/L Standard Deviation 67.158
Change From Baseline in C-Reactive Protein (CRP) Day 5	-62.300 mg/L Standard Deviation 125.644	-36.272 mg/L Standard Deviation 112.545
Change From Baseline in C-Reactive Protein (CRP) Day 8	-73.118 mg/L Standard Deviation 162.628	-49.618 mg/L Standard Deviation 88.759
Change From Baseline in C-Reactive Protein (CRP) Day 11	-33.713 mg/L Standard Deviation 112.260	-48.647 mg/L Standard Deviation 108.481
Change From Baseline in C-Reactive Protein (CRP) Day 15	-48.847 mg/L Standard Deviation 95.126	-61.548 mg/L Standard Deviation 75.000
Change From Baseline in C-Reactive Protein (CRP) Day 29	-65.175 mg/L Standard Deviation 82.724	-70.728 mg/L Standard Deviation 73.967

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in D-dimer Day 3	496.548 µg/L fibrinogen equivalent units (FEU) Standard Deviation 5714.241	994.162 µg/L fibrinogen equivalent units (FEU) Standard Deviation 5752.139
Change From Baseline in D-dimer Day 5	1779.571 µg/L fibrinogen equivalent units (FEU) Standard Deviation 7877.791	2704.873 µg/L fibrinogen equivalent units (FEU) Standard Deviation 11751.741
Change From Baseline in D-dimer Day 8	2104.619 µg/L fibrinogen equivalent units (FEU) Standard Deviation 8930.666	1544.558 µg/L fibrinogen equivalent units (FEU) Standard Deviation 13145.089
Change From Baseline in D-dimer Day 11	1937.748 µg/L fibrinogen equivalent units (FEU) Standard Deviation 9253.749	1304.639 µg/L fibrinogen equivalent units (FEU) Standard Deviation 6733.679
Change From Baseline in D-dimer Day 15	184.022 µg/L fibrinogen equivalent units (FEU) Standard Deviation 6162.040	422.458 µg/L fibrinogen equivalent units (FEU) Standard Deviation 6104.354
Change From Baseline in D-dimer Day 29	-328.954 µg/L fibrinogen equivalent units (FEU) Standard Deviation 5271.468	-736.771 µg/L fibrinogen equivalent units (FEU) Standard Deviation 4978.655

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Ferritin Day 3	-156.894 µg/L Standard Deviation 1248.855	-204.033 µg/L Standard Deviation 584.563
Change From Baseline in Ferritin Day 5	-303.466 µg/L Standard Deviation 1400.684	-254.803 µg/L Standard Deviation 1396.688
Change From Baseline in Ferritin Day 8	-494.266 µg/L Standard Deviation 1042.361	-403.031 µg/L Standard Deviation 889.021
Change From Baseline in Ferritin Day 11	-453.304 µg/L Standard Deviation 1209.069	-426.838 µg/L Standard Deviation 1166.825
Change From Baseline in Ferritin Day 15	-304.447 µg/L Standard Deviation 1013.592	-552.903 µg/L Standard Deviation 907.992
Change From Baseline in Ferritin Day 29	-645.899 µg/L Standard Deviation 1246.980	-839.410 µg/L Standard Deviation 1002.701

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Fibrinogen Day 3	-90.5 mg/dL Standard Deviation 109.1	-90.3 mg/dL Standard Deviation 121.8
Change From Baseline in Fibrinogen Day 5	-94.3 mg/dL Standard Deviation 415.2	-104.9 mg/dL Standard Deviation 171.6
Change From Baseline in Fibrinogen Day 8	-126.6 mg/dL Standard Deviation 200.5	-120.8 mg/dL Standard Deviation 208.7
Change From Baseline in Fibrinogen Day 11	-47.8 mg/dL Standard Deviation 238.4	-83.5 mg/dL Standard Deviation 260.9
Change From Baseline in Fibrinogen Day 15	-53.4 mg/dL Standard Deviation 229.6	-70.0 mg/dL Standard Deviation 208.1
Change From Baseline in Fibrinogen Day 29	-145.7 mg/dL Standard Deviation 177.2	-118.9 mg/dL Standard Deviation 191.4

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Alanine Aminotransferase (ALT) Day 3	6.4 U/L Standard Deviation 42.6	4.0 U/L Standard Deviation 34.0
Change From Baseline in Alanine Aminotransferase (ALT) Day 5	29.3 U/L Standard Deviation 146.8	29.7 U/L Standard Deviation 189.1
Change From Baseline in Alanine Aminotransferase (ALT) Day 8	19.7 U/L Standard Deviation 108.8	9.2 U/L Standard Deviation 108.3
Change From Baseline in Alanine Aminotransferase (ALT) Day 11	9.8 U/L Standard Deviation 71.6	7.8 U/L Standard Deviation 83.4
Change From Baseline in Alanine Aminotransferase (ALT) Day 15	15.7 U/L Standard Deviation 71.5	-2.5 U/L Standard Deviation 48.5
Change From Baseline in Alanine Aminotransferase (ALT) Day 29	17.3 U/L Standard Deviation 158.5	12.4 U/L Standard Deviation 256.0

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 to evaluate AST 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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Aspartate Transaminase (AST) Day 3	-5.9 U/L Standard Deviation 41.2	-7.5 U/L Standard Deviation 31.7
Change From Baseline in Aspartate Transaminase (AST) Day 5	-1.0 U/L Standard Deviation 64.5	12.2 U/L Standard Deviation 276.7
Change From Baseline in Aspartate Transaminase (AST) Day 8	-17.7 U/L Standard Deviation 46.6	-1.8 U/L Standard Deviation 243.0
Change From Baseline in Aspartate Transaminase (AST) Day 11	-16.6 U/L Standard Deviation 77.7	1.5 U/L Standard Deviation 194.7
Change From Baseline in Aspartate Transaminase (AST) Day 15	-9.6 U/L Standard Deviation 55.7	-21.0 U/L Standard Deviation 40.0
Change From Baseline in Aspartate Transaminase (AST) Day 29	-9.6 U/L Standard Deviation 51.8	17.4 U/L Standard Deviation 404.9

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Creatinine Day 3	-0.060 mg/dL Standard Deviation 0.134	-0.028 mg/dL Standard Deviation 0.215
Change From Baseline in Creatinine Day 5	-0.053 mg/dL Standard Deviation 0.307	-0.019 mg/dL Standard Deviation 0.392
Change From Baseline in Creatinine Day 8	-0.020 mg/dL Standard Deviation 0.672	-0.038 mg/dL Standard Deviation 0.379
Change From Baseline in Creatinine Day 11	0.012 mg/dL Standard Deviation 0.715	0.210 mg/dL Standard Deviation 0.875
Change From Baseline in Creatinine Day 15	-0.037 mg/dL Standard Deviation 0.321	0.188 mg/dL Standard Deviation 0.868
Change From Baseline in Creatinine Day 29	0.049 mg/dL Standard Deviation 0.612	0.155 mg/dL Standard Deviation 0.986

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in International Normalized Ratio (INR) Day 3	0.01352 Ratio Standard Deviation 0.14308	0.05065 Ratio Standard Deviation 0.18246
Change From Baseline in International Normalized Ratio (INR) Day 5	-0.00790 Ratio Standard Deviation 0.96495	0.10552 Ratio Standard Deviation 0.46849
Change From Baseline in International Normalized Ratio (INR) Day 8	-0.07588 Ratio Standard Deviation 1.18790	0.13077 Ratio Standard Deviation 0.96702
Change From Baseline in International Normalized Ratio (INR) Day 11	0.03758 Ratio Standard Deviation 0.23576	0.06652 Ratio Standard Deviation 0.23513
Change From Baseline in International Normalized Ratio (INR) Day 15	-0.01725 Ratio Standard Deviation 0.20340	-0.00704 Ratio Standard Deviation 0.19225
Change From Baseline in International Normalized Ratio (INR) Day 29	-0.08386 Ratio Standard Deviation 0.16724	0.07535 Ratio Standard Deviation 1.12891

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Hemoglobin Day 3	-0.27 g/dL Standard Deviation 0.94	-0.20 g/dL Standard Deviation 0.99
Change From Baseline in Hemoglobin Day 5	-0.31 g/dL Standard Deviation 1.10	-0.34 g/dL Standard Deviation 1.13
Change From Baseline in Hemoglobin Day 8	-0.50 g/dL Standard Deviation 1.38	-0.48 g/dL Standard Deviation 1.29
Change From Baseline in Hemoglobin Day 11	-1.03 g/dL Standard Deviation 1.54	-0.99 g/dL Standard Deviation 1.79
Change From Baseline in Hemoglobin Day 15	-1.22 g/dL Standard Deviation 1.68	-1.28 g/dL Standard Deviation 1.93
Change From Baseline in Hemoglobin Day 29	-1.27 g/dL Standard Deviation 2.24	-1.21 g/dL Standard Deviation 2.06

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Platelets Count Day 3	52.99 10^9 cells/L Standard Deviation 59.89	47.61 10^9 cells/L Standard Deviation 60.99
Change From Baseline in Platelets Count Day 5	84.38 10^9 cells/L Standard Deviation 84.63	72.92 10^9 cells/L Standard Deviation 91.73
Change From Baseline in Platelets Count Day 8	103.33 10^9 cells/L Standard Deviation 127.75	83.09 10^9 cells/L Standard Deviation 133.33
Change From Baseline in Platelets Count Day 11	54.43 10^9 cells/L Standard Deviation 124.09	31.99 10^9 cells/L Standard Deviation 138.63
Change From Baseline in Platelets Count Day 15	27.23 10^9 cells/L Standard Deviation 123.15	-3.72 10^9 cells/L Standard Deviation 118.35
Change From Baseline in Platelets Count Day 29	15.11 10^9 cells/L Standard Deviation 91.84	59.53 10^9 cells/L Standard Deviation 117.47

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Total Bilirubin Day 3	-0.049 mg/dL Standard Deviation 0.210	-0.039 mg/dL Standard Deviation 0.508
Change From Baseline in Total Bilirubin Day 5	0.064 mg/dL Standard Deviation 0.318	0.007 mg/dL Standard Deviation 0.592
Change From Baseline in Total Bilirubin Day 8	0.082 mg/dL Standard Deviation 0.348	0.068 mg/dL Standard Deviation 0.318
Change From Baseline in Total Bilirubin Day 11	0.096 mg/dL Standard Deviation 0.366	0.097 mg/dL Standard Deviation 0.488
Change From Baseline in Total Bilirubin Day 15	0.078 mg/dL Standard Deviation 0.494	0.022 mg/dL Standard Deviation 0.840
Change From Baseline in Total Bilirubin Day 29	-0.043 mg/dL Standard Deviation 0.268	-0.101 mg/dL Standard Deviation 0.938

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in White Blood Cell (WBC) Count Day 3	1.1678 10^9 cells/L Standard Deviation 3.1129	1.7775 10^9 cells/L Standard Deviation 3.1355
Change From Baseline in White Blood Cell (WBC) Count Day 5	3.1761 10^9 cells/L Standard Deviation 4.6732	2.4411 10^9 cells/L Standard Deviation 4.0829
Change From Baseline in White Blood Cell (WBC) Count Day 8	5.9017 10^9 cells/L Standard Deviation 5.8181	4.6654 10^9 cells/L Standard Deviation 4.8122
Change From Baseline in White Blood Cell (WBC) Count Day 11	6.9859 10^9 cells/L Standard Deviation 6.5458	6.0658 10^9 cells/L Standard Deviation 7.6772
Change From Baseline in White Blood Cell (WBC) Count Day 15	3.3979 10^9 cells/L Standard Deviation 6.2653	2.2880 10^9 cells/L Standard Deviation 6.3102
Change From Baseline in White Blood Cell (WBC) Count Day 29	-0.3185 10^9 cells/L Standard Deviation 5.2892	-0.1199 10^9 cells/L Standard Deviation 5.5121

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Neutrophils Day 3	0.4146 10^9 cells/L Standard Deviation 2.7458	1.4128 10^9 cells/L Standard Deviation 3.0236
Change From Baseline in Neutrophils Day 5	1.8626 10^9 cells/L Standard Deviation 4.3986	1.5750 10^9 cells/L Standard Deviation 3.4220
Change From Baseline in Neutrophils Day 8	4.2520 10^9 cells/L Standard Deviation 4.7959	3.5547 10^9 cells/L Standard Deviation 4.7093
Change From Baseline in Neutrophils Day 11	5.3638 10^9 cells/L Standard Deviation 6.4333	5.0504 10^9 cells/L Standard Deviation 7.2784
Change From Baseline in Neutrophils Day 15	1.8136 10^9 cells/L Standard Deviation 5.8546	0.6347 10^9 cells/L Standard Deviation 4.7580
Change From Baseline in Neutrophils Day 29	-2.0352 10^9 cells/L Standard Deviation 4.3887	-1.2712 10^9 cells/L Standard Deviation 4.2090

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Eosinophils Day 3	0.00234 10^9 cells/L Standard Deviation 0.05634	0.00298 10^9 cells/L Standard Deviation 0.06616
Change From Baseline in Eosinophils Day 5	0.03413 10^9 cells/L Standard Deviation 0.11473	0.02668 10^9 cells/L Standard Deviation 0.06469
Change From Baseline in Eosinophils Day 8	0.08446 10^9 cells/L Standard Deviation 0.11300	0.05383 10^9 cells/L Standard Deviation 0.14607
Change From Baseline in Eosinophils Day 11	0.19746 10^9 cells/L Standard Deviation 0.40542	0.10947 10^9 cells/L Standard Deviation 0.14440
Change From Baseline in Eosinophils Day 15	0.21128 10^9 cells/L Standard Deviation 0.20800	0.14547 10^9 cells/L Standard Deviation 0.13429
Change From Baseline in Eosinophils Day 29	0.32429 10^9 cells/L Standard Deviation 0.31412	0.25893 10^9 cells/L Standard Deviation 0.26106

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Basophils Day 3	0.01003 10^9 cells/L Standard Deviation 0.06346	0.01082 10^9 cells/L Standard Deviation 0.04173
Change From Baseline in Basophils Day 5	0.00944 10^9 cells/L Standard Deviation 0.05689	0.01103 10^9 cells/L Standard Deviation 0.02979
Change From Baseline in Basophils Day 8	0.00680 10^9 cells/L Standard Deviation 0.04749	0.01679 10^9 cells/L Standard Deviation 0.03481
Change From Baseline in Basophils Day 11	0.03623 10^9 cells/L Standard Deviation 0.07673	0.02402 10^9 cells/L Standard Deviation 0.04017
Change From Baseline in Basophils Day 15	0.04123 10^9 cells/L Standard Deviation 0.06928	0.02566 10^9 cells/L Standard Deviation 0.04527
Change From Baseline in Basophils Day 29	0.04311 10^9 cells/L Standard Deviation 0.05582	0.03504 10^9 cells/L Standard Deviation 0.06657

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. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Lymphocytes Day 3	0.4191 10^9 cells/L Standard Deviation 1.1325	0.2191 10^9 cells/L Standard Deviation 0.7106
Change From Baseline in Lymphocytes Day 5	0.4585 10^9 cells/L Standard Deviation 0.7820	0.2772 10^9 cells/L Standard Deviation 0.5947
Change From Baseline in Lymphocytes Day 8	0.6283 10^9 cells/L Standard Deviation 1.1126	0.2002 10^9 cells/L Standard Deviation 1.1396
Change From Baseline in Lymphocytes Day 11	1.0750 10^9 cells/L Standard Deviation 3.8905	0.3911 10^9 cells/L Standard Deviation 0.7718
Change From Baseline in Lymphocytes Day 15	0.7693 10^9 cells/L Standard Deviation 0.7193	0.5923 10^9 cells/L Standard Deviation 0.6609
Change From Baseline in Lymphocytes Day 29	0.8496 10^9 cells/L Standard Deviation 0.6764	0.7451 10^9 cells/L Standard Deviation 0.9669

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. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Change From Baseline in Monocytes Day 3	0.2490 10^9 cells/L Standard Deviation 1.3094	0.1750 10^9 cells/L Standard Deviation 0.6263
Change From Baseline in Monocytes Day 5	0.3012 10^9 cells/L Standard Deviation 1.0631	0.1275 10^9 cells/L Standard Deviation 0.4584
Change From Baseline in Monocytes Day 8	0.4774 10^9 cells/L Standard Deviation 1.3914	0.1794 10^9 cells/L Standard Deviation 0.5609
Change From Baseline in Monocytes Day 11	0.6291 10^9 cells/L Standard Deviation 1.3902	0.2865 10^9 cells/L Standard Deviation 0.7489
Change From Baseline in Monocytes Day 15	0.3195 10^9 cells/L Standard Deviation 0.5866	0.3074 10^9 cells/L Standard Deviation 0.8821
Change From Baseline in Monocytes Day 29	0.1079 10^9 cells/L Standard Deviation 0.3481	0.0820 10^9 cells/L Standard Deviation 0.5578

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 while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants Reporting Grade 3, 4, or 5 Clinical and/or Laboratory Adverse Events (AEs)	133 Participants	124 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 + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants Reporting Serious Adverse Events (SAEs)	76 Participants	81 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 + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants Who Discontinued or Temporarily Suspended Study Treatment	6 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Duration of Hospitalization Hospitalized for COVID-19	8.0 days Interval 5.0 to 18.0	8.0 days Interval 5.0 to 19.0
Duration of Hospitalization Hospitalized for Any Reason	8.0 days Interval 5.0 to 18.0	8.0 days Interval 5.0 to 19.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants.

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

Outcome measures

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
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

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants. 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 + Lenzilumab n=265 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=248 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Days of New Mechanical Ventilation or 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 intention-to-treat (ITT) population includes all randomized participants.

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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Days of Non-invasive Ventilation/High Flow Oxygen Use	1.0 days Interval 0.0 to 11.0	2.0 days Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (mITT) population includes all randomized participants. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better 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 + Lenzilumab n=171 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=173 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Days of New Non-invasive Ventilation/High Flow Oxygen Use	0.0 days Interval 0.0 to 1.0	0.0 days Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (mITT) population includes all randomized participants.

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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Days of Supplemental Oxygen Use	13.5 days Interval 4.0 to 28.0	14.0 days Interval 5.0 to 28.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants. 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 + Lenzilumab n=265 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=248 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use	44 Participants	47 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better 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 noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.

Outcome measures

Measure	Remdesivir + Lenzilumab n=171 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=173 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use	49 Participants	62 Participants

SECONDARY outcome

Timeframe: Days 1, 3, 5, 8, 11, 15, 22, 29

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 highflow 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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Mean Change in Ordinal Scale Day 29	-2.8 units on a scale Standard Deviation 2.2	-2.6 units on a scale Standard Deviation 2.3
Mean Change in Ordinal Scale Day 3	0.0 units on a scale Standard Deviation 0.6	0.1 units on a scale Standard Deviation 0.4
Mean Change in Ordinal Scale Day 5	-0.3 units on a scale Standard Deviation 1.1	-0.2 units on a scale Standard Deviation 1.1
Mean Change in Ordinal Scale Day 8	-1.3 units on a scale Standard Deviation 1.9	-1.3 units on a scale Standard Deviation 2.0
Mean Change in Ordinal Scale Day 11	-1.8 units on a scale Standard Deviation 2.0	-1.8 units on a scale Standard Deviation 2.0
Mean Change in Ordinal Scale Day 15	-2.3 units on a scale Standard Deviation 2.2	-2.2 units on a scale Standard Deviation 2.2
Mean Change in Ordinal Scale Day 22	-2.6 units on a scale Standard Deviation 2.1	-2.4 units on a scale Standard Deviation 2.3

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 + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
14-day Participant Mortality	0.05 Proportion of participants Interval 0.03 to 0.09	0.07 Proportion of participants Interval 0.04 to 0.11

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 + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
28-day Participant Mortality	0.10 Proportion of participants Interval 0.07 to 0.15	0.12 Proportion of participants Interval 0.09 to 0.17

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 + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
59-day Participant Mortality	0.12 Proportion of participants Interval 0.08 to 0.17	0.16 Proportion of participants Interval 0.12 to 0.21

SECONDARY outcome

Timeframe: Day 29

Population: The intention-to-treat (ITT) population includes all randomized participants.

Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. 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 + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29	0.86 Proportion of participants Interval 0.81 to 0.9	0.83 Proportion of participants Interval 0.78 to 0.87

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Time to an Improvement of One Category From Baseline Using an Ordinal Scale	8.0 days Interval 6.0 to 10.0	7.0 days Interval 7.0 to 10.0

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: The intention-to-treat (ITT) population includes all randomized participants.

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 noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Outcome measures

Measure	Remdesivir + Lenzilumab n=272 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=255 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale	13.0 days Due to a large number of participants improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval	13.0 days Interval 12.0 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 to death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.

Outcome measures

Measure	Remdesivir + Lenzilumab n=264 Participants 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 Participants 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Time to Death	NA days Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)	NA days Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)

Adverse Events

Remdesivir + Lenzilumab

Serious events: 76 serious events

Other events: 41 other events

Deaths: 31 deaths

Remdesivir + Placebo

Serious events: 81 serious events

Other events: 54 other events

Deaths: 38 deaths

Serious adverse events

Measure	Remdesivir + Lenzilumab n=264 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Blood and lymphatic system disorders Anaemia	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.2% 3/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Acute left ventricular failure	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Acute myocardial infarction	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Arrhythmia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.2% 3/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Atrial fibrillation	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Bradycardia	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Cardiac arrest	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Cardiac failure	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Cardiac failure congestive	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Cardiopulmonary failure	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Intracardiac thrombus	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Pulseless electrical activity	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Right ventricular failure	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Supraventricular tachycardia	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Cardiac disorders Tachycardia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
General disorders Multiple organ dysfunction syndrome	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
General disorders Non-cardiac chest pain	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Hepatobiliary disorders Hepatic failure	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Abdominal sepsis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Bacteraemia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Bacterial sepsis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Bacterial tracheitis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations COVID-19 pneumonia	1.1% 3/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Empyema	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Endocarditis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Enterobacter infection	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Lung abscess	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Pneumonia	2.7% 7/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Pneumonia bacterial	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.2% 3/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Pneumonia staphylococcal	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Sepsis	1.5% 4/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.6% 4/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Septic shock	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	2.4% 6/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Streptococcal bacteraemia	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Infections and infestations Tuberculosis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Injury, poisoning and procedural complications Overdose	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Alanine aminotransferase increased	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Aspartate aminotransferase increased	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Blood creatinine increased	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Glomerular filtration rate decreased	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Lymphocyte count decreased	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Oxygen saturation decreased	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Transaminases increased	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations White blood cell count increased	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Metabolism and nutrition disorders Acidosis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Ataxia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Brain injury	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Cerebral haemorrhage	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Cerebrovascular accident	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Dementia	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Depressed level of consciousness	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Guillain-Barre syndrome	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Haemorrhagic stroke	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Ischaemic stroke	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Leukoencephalopathy	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Nervous system disorders Toxic encephalopathy	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Psychiatric disorders Delirium	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Renal and urinary disorders Acute kidney injury	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	3.6% 9/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Renal and urinary disorders Renal failure	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.80% 2/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Renal and urinary disorders Renal tubular necrosis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.1% 3/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	6.1% 16/264 • Number of events 16 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	9.2% 23/250 • Number of events 24 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 3/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	2.0% 5/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.1% 3/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.2% 3/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.0% 8/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	2.0% 5/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	2.0% 5/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.8% 26/264 • Number of events 26 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	10.8% 27/250 • Number of events 28 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Surgical and medical procedures Gastrectomy	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Aortic thrombosis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Deep vein thrombosis	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.6% 4/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Embolism venous	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Haemodynamic instability	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Haemorrhage	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Hypertension	0.38% 1/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.00% 0/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Hypotension	0.76% 2/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.2% 3/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Hypovolaemic shock	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Peripheral artery occlusion	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Shock	1.9% 5/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	1.6% 4/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Thrombosis	0.00% 0/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	0.40% 1/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.

Other adverse events

Measure	Remdesivir + Lenzilumab n=264 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 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.	Remdesivir + Placebo n=250 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 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.
Investigations Glomerular filtration rate decreased	3.0% 8/264 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	6.0% 15/250 • Number of events 18 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Investigations Lymphocyte count decreased	4.2% 11/264 • Number of events 12 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	8.0% 20/250 • Number of events 23 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.4% 17/264 • Number of events 19 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	2.4% 6/250 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.
Vascular disorders Hypertension	4.2% 11/264 • Number of events 12 • 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 all enrolled participants, while SAEs and AEs reflect the as safety population.	7.6% 19/250 • Number of events 26 • 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 all enrolled participants, while SAEs and AEs reflect the as safety 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