Trial Outcomes & Findings for Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (NCT NCT04376684)

Last Updated: 2024-09-23

Results Overview

Participants were considered alive and free of respiratory failure if they were in category 1, 2, 3, or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (greater than or equal to \[\>=\]15 liters per minute \[L/min\]), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Higher scale indicates higher intensity of respiratory failure. Percentage values are rounded off.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1156 participants

Primary outcome timeframe

At Day 28

Results posted on

2024-09-23

Participant Flow

This was a 2-part study evaluating efficacy and safety of intravenously (IV) administered otilimab in participants with severe pulmonary Coronavirus Disease-2019 (COVID-19) related disease. Part 1 consisted of participants aged 18 to 79 years and Part 2 consisted of participants aged 70 years and older.

A total of 1156 (806 in Part 1 and 350 in Part 2) participants were enrolled in the study (Enrolled Population: All participants who entered the study).

Participant milestones

Participant milestones
Measure	Part 1: Placebo 1 Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.	Part 2: Placebo 2 Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.	Part 2: Otilimab 90 mg Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
Part 1 (Up to Day 60) STARTED	403	403	0	0
Part 1 (Up to Day 60) COMPLETED	388	379	0	0
Part 1 (Up to Day 60) NOT COMPLETED	15	24	0	0
Part 2 (Up to Day 60) STARTED	0	0	175	175
Part 2 (Up to Day 60) COMPLETED	0	0	170	171
Part 2 (Up to Day 60) NOT COMPLETED	0	0	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Placebo 1 Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.	Part 2: Placebo 2 Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.	Part 2: Otilimab 90 mg Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
Part 1 (Up to Day 60) Withdrawal by Subject	7	8	0	0
Part 1 (Up to Day 60) Protocol Violation	2	3	0	0
Part 1 (Up to Day 60) Physician Decision	2	5	0	0
Part 1 (Up to Day 60) Lost to Follow-up	4	8	0	0
Part 2 (Up to Day 60) Withdrawal by Subject	0	0	1	1
Part 2 (Up to Day 60) Physician Decision	0	0	1	1
Part 2 (Up to Day 60) Lost to Follow-up	0	0	3	2

Baseline Characteristics

Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Placebo 1 n=403 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=403 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.	Part 2: Placebo 2 n=175 Participants Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.	Part 2: Otilimab 90 mg n=175 Participants Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.	Total n=1156 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Between 18 to 64 years	249 Participants n=5 Participants	250 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	499 Participants n=21 Participants
Age, Customized >=65 to 84 years	154 Participants n=5 Participants	153 Participants n=7 Participants	168 Participants n=5 Participants	168 Participants n=4 Participants	643 Participants n=21 Participants
Age, Customized >=85 years	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	101 Participants n=7 Participants	75 Participants n=5 Participants	73 Participants n=4 Participants	377 Participants n=21 Participants
Sex: Female, Male Male	275 Participants n=5 Participants	302 Participants n=7 Participants	100 Participants n=5 Participants	102 Participants n=4 Participants	779 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	24 Participants n=5 Participants	30 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	65 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	42 Participants n=5 Participants	31 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	74 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	15 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	5 Participants n=4 Participants	47 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	12 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=5 Participants	26 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	63 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	27 Participants n=5 Participants	21 Participants n=7 Participants	14 Participants n=5 Participants	21 Participants n=4 Participants	83 Participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	235 Participants n=5 Participants	251 Participants n=7 Participants	136 Participants n=5 Participants	134 Participants n=4 Participants	756 Participants n=21 Participants
Race/Ethnicity, Customized Mixed Asian Race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Mixed White Race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	7 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	11 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	21 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Day 28

Population: Modified intent to treat (mITT) Population consisted of all randomized participants who received study intervention. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=393 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=389 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28	67 Percentage of participants	71 Percentage of participants

PRIMARY outcome

Timeframe: At Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Participants were alive and free of respiratory failure if they were in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (\>=15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Higher scale indicates higher intensity of respiratory failure. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=172 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 28	51 Percentage of participants	52 Percentage of participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Number of participants who died due to all causes at Day 60 are reported.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=386 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=373 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Number of Participants Who Died Due to All Causes at Day 60	93 Participants	84 Participants

SECONDARY outcome

Timeframe: At Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Number of participants who died due to all causes at Day 28 is reported

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=172 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Number of Participants Who Died Due to All Causes at Day 28	70 Participants	63 Participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Number of participants who died due to all causes at Day 60 is reported

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=171 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Number of Participants Who Died Due to All Causes at Day 60	76 Participants	74 Participants

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to death due to all causes was defined as the time (days) from dosing to death, due to any cause, up to (and including) Day 60. Median and inter-quartile range (first quartile and third quartile) of time to death are presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=93 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=84 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to Death Due to All Causes up to Day 60	NA Days \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.	NA Days \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=76 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=74 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to Death Due to All Causes up to Day 60	NA Days Interval 16.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.	NA Days Interval 16.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.

SECONDARY outcome

Timeframe: At Day 7

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=396 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=393 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 7	42 Percentage of participants	44 Percentage of participants

SECONDARY outcome

Timeframe: At Day 14

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=394 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=391 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 14	61 Percentage of participants	63 Percentage of participants

SECONDARY outcome

Timeframe: At Day 42

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=392 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=385 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 42	70 Percentage of participants	74 Percentage of participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=386 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=373 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 60	74 Percentage of participants	75 Percentage of participants

SECONDARY outcome

Timeframe: At Day 7

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=173 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=174 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 7	28 Percentage of participants	37 Percentage of participants

SECONDARY outcome

Timeframe: At Day 14

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=171 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=174 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 14	43 Percentage of participants	49 Percentage of participants

SECONDARY outcome

Timeframe: At Day 42

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=172 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 42	54 Percentage of participants	54 Percentage of participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=171 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 60	55 Percentage of participants	56 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to recovery from respiratory failure was defined as the time (days) from dosing to last recovery from respiratory failure up to (and including) Day 28. Participants were in respiratory failure if they were in category 5 or above from the GlaxoSmithKline (GSK) modified ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (\>=15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Median and inter-quartile range (first quartile and third quartile) of time to recovery from respiratory failure are presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=263 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=281 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to Recovery From Respiratory Failure up to Day 28	10 Days Interval 5.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	9 Days Interval 5.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=90 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=91 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to Recovery From Respiratory Failure up to Day 28	24 Days Interval 7.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	22 Days Interval 5.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: At Day 7

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Participants were independent of supplementary oxygen if they were in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (\>=15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=396 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=393 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7	11 Percentage of participants	12 Percentage of participants

SECONDARY outcome

Timeframe: At Day 14

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=394 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=391 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14	37 Percentage of participants	37 Percentage of participants

SECONDARY outcome

Timeframe: At Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=393 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=389 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28	57 Percentage of participants	57 Percentage of participants

SECONDARY outcome

Timeframe: At Day 42

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=392 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=385 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42	63 Percentage of participants	66 Percentage of participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=386 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=373 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60	67 Percentage of participants	71 Percentage of participants

SECONDARY outcome

Timeframe: At Day 7

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=173 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=174 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7	3 Percentage of participants	13 Percentage of participants

SECONDARY outcome

Timeframe: At Day 14

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=171 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=174 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14	23 Percentage of participants	28 Percentage of participants

SECONDARY outcome

Timeframe: At Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=172 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28	39 Percentage of participants	38 Percentage of participants

SECONDARY outcome

Timeframe: At Day 42

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=172 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42	46 Percentage of participants	41 Percentage of participants

SECONDARY outcome

Timeframe: At Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=170 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=171 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60	51 Percentage of participants	46 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to last dependence on supplementary oxygen was defined as the time (days) from dosing to last dependence on supplementary oxygen up to (and including) Day 28. Median and inter-quartile range (first quartile and third quartile) of time to last dependence on supplementary oxygen are presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=223 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=221 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to Last Dependence on Supplementary Oxygen	22 Days Interval 11.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	21 Days Interval 10.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=66 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=68 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to Last Dependence on Supplementary Oxygen	NA Days Interval 15.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.	NA Days Interval 13.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population (not in ICU at Baseline) comprised of participants in the mITT population who were not in the ICU at Baseline. Only those participants with data available at the specified time points were analyzed.

Participants who were admitted to the ICU up to (and including) Day 28 were evaluated. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=98 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=95 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Percentage of Participants Admitted to Intensive Care Unit (ICU) up to Day 28	29 Percentage of participants	16 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population admitted to ICU at Baseline comprised of those participants in mITT who were admitted to ICU at Baseline. Only those participants with data available at the specified time points were analyzed.

Time to final ICU discharge was defined as the time from dosing to when the participant is discharged from the ICU for the last time up to (and including) Day 28. Median and inter-quartile range (first quartile and third quartile) of time to final ICU discharge is presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=300 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=300 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to Final ICU Discharge	13 Days Interval 7.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	15 Days Interval 7.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 28

Population: mITT Population admitted to ICU at Baseline. Only those participants with data available at the specified time points were analyzed.

Time to final ICU discharge was defined as the time from dosing to when the participant was discharged from the ICU for the last time up to (and including) Day 28. Median and inter-quartile range (first quartile and third quartile) of time to final ICU discharge is presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=38 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=44 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to Final ICU Discharge	NA Days Interval 12.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.	NA Days Interval 7.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to first discharge from investigator site was defined as the time (days) from dosing to when the participant was first discharged from investigator site (IS) up to (and including) Day 60. Median and inter-quartile range (first quartile and third quartile) of time to first discharge from investigator site is presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=288 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=294 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to First Discharge From Investigator Site up to Day 60	18 Days Interval 11.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	18 Days Interval 10.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to first discharge to non-hospitalized residence was defined as the time (days) from dosing to when the participant was discharged to a non-hospitalized residence for the first time up to (and including) Day 60. Median and inter-quartile range (first quartile and third quartile) of time to first discharge to non-hospitalized residence is presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=269 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=280 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Time to First Discharge to Non-hospitalized Residence up to Day 60	21 Days Interval 12.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	20 Days Interval 11.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Time to first discharge from investigator site was defined as the time (days) from dosing to when the participant was first discharged from investigator site up to (and including) Day 60. Median and inter-quartile range (first quartile and third quartile) of time to first discharge from investigator site is presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=96 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=99 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to First Discharge From Investigator Site up to Day 60	36 Days Interval 15.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	37 Days Interval 15.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: mITT Population. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=86 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=90 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Time to First Discharge to Non-hospitalized Residence	NA Days Interval 18.0 to \<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.	53 Days Interval 15.0 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Up to Day 60

Population: Safety population comprised of all participants who received study intervention

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=396 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=397 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Non-SAEs	67 Participants	91 Participants
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) SAEs	147 Participants	124 Participants

SECONDARY outcome

Timeframe: Up to Day 60

Population: Safety population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented.

Outcome measures

Outcome measures
Measure	Part 1: Placebo 1 n=173 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=174 Participants Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.
Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs Non-SAEs	57 Participants	50 Participants
Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs SAEs	90 Participants	90 Participants

Adverse Events

Part 1: Placebo 1

Serious events: 147 serious events

Other events: 97 other events

Deaths: 93 deaths

Part 1: Otilimab 90 mg

Serious events: 124 serious events

Other events: 115 other events

Deaths: 84 deaths

Part 2: Placebo 2

Serious events: 90 serious events

Other events: 57 other events

Deaths: 76 deaths

Part 2: Otilimab 90 mg

Serious events: 90 serious events

Other events: 51 other events

Deaths: 74 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Part 1: Placebo 1 n=396 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent \[%\] weight by volume \[w/v\] sodium chloride solution) once along with standard of care.	Part 1: Otilimab 90 mg n=397 participants at risk Participants between the ages of \>=18 years and \<=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care.	Part 2: Placebo 2 n=173 participants at risk Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care.	Part 2: Otilimab 90 mg n=174 participants at risk Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care.
Gastrointestinal disorders Constipation	8.8% 35/396 • Number of events 35 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	9.8% 39/397 • Number of events 42 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	8.7% 15/173 • Number of events 16 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	9.2% 16/174 • Number of events 16 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Infections and infestations Pneumonia	5.3% 21/396 • Number of events 21 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	9.3% 37/397 • Number of events 43 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	6.9% 12/173 • Number of events 12 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	3.4% 6/174 • Number of events 7 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Blood and lymphatic system disorders Anaemia	5.6% 22/396 • Number of events 22 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	4.5% 18/397 • Number of events 19 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.8% 10/173 • Number of events 10 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	6.3% 11/174 • Number of events 11 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Renal and urinary disorders Acute kidney injury	4.3% 17/396 • Number of events 18 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	3.8% 15/397 • Number of events 16 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	6.4% 11/173 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	4.6% 8/174 • Number of events 9 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Vascular disorders Hypotension	3.3% 13/396 • Number of events 17 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	3.3% 13/397 • Number of events 14 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	6.4% 11/173 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.2% 9/174 • Number of events 11 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Cardiac disorders Atrial fibrillation	3.8% 15/396 • Number of events 15 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	2.8% 11/397 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.8% 10/173 • Number of events 11 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	4.0% 7/174 • Number of events 7 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Metabolism and nutrition disorders Hyperglycaemia	3.5% 14/396 • Number of events 15 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	3.0% 12/397 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	2.3% 4/173 • Number of events 5 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.7% 10/174 • Number of events 14 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Infections and infestations Urinary tract infection	3.3% 13/396 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	3.0% 12/397 • Number of events 13 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.8% 10/173 • Number of events 10 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	2.9% 5/174 • Number of events 5 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Metabolism and nutrition disorders Hypernatraemia	2.3% 9/396 • Number of events 9 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.0% 20/397 • Number of events 22 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	0.58% 1/173 • Number of events 1 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	1.7% 3/174 • Number of events 4 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).
Metabolism and nutrition disorders Fluid overload	0.51% 2/396 • Number of events 2 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	0.25% 1/397 • Number of events 1 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	2.9% 5/173 • Number of events 5 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).	5.2% 9/174 • Number of events 10 • All-cause mortality, SAEs, and non-SAEs were collected up to Day 60 in Part 1 and 2 of the study SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who received study intervention. All-cause mortality was reported for Enrolled population (all participants who entered the study). Sixteen participants from Enrolled Population (N=1156) did not receive study treatment, hence were not included in Safety Population (N=1140).

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