A Study to Evaluate the Safety and Efficacy of MSTT1041A... | NCT04386616

ID	Type	Description	Link
2020-002713-17	EudraCT Number
OT number: HHSO100201800036C	Other Grant/Funding Number	Biomedical Advanced Research and Development Authority

Name	Class
Biomedical Advanced Research and Development Authority	FED

Label	Type	Description	Intervention Names
All Placebo	Placebo Comparator	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	Drug: MSTT1041A-matched Placebo Drug: UTTR1147A-matched Placebo
MSTT1041A	Experimental	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	Drug: MSTT1041A
UTTR1147A	Experimental	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	Drug: UTTR1147A

Name	Type	Description	Arm Group Labels	Other Names
MSTT1041A	Drug	Participants received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen.

Measure	Description	Time Frame
Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28	The time to recovery was defined as the time from baseline to a clinical status score of 1 or 2 on the 7-category ordinal scale (whichever occurs first); clinical status scores are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death.	From Baseline up to 28 days

Measure	Description	Time Frame
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status by Day 28	The 7 categories of the clinical status ordinal scale are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas For Medical Sciences		Little Rock	Arkansas	72205	United States
eStudySite - Chula Vista - PPDS

PubMed Identifier	Type	Citation	Retractions
36519984	Derived	Waters M, McKinnell JA, Kalil AC, Martin GS, Buchman TG, Theess W, Yang X, Lekkerkerker AN, Staton T, Rosenberger CM, Pappu R, Wang Y, Zhang W, Brooks L, Cheung D, Galanter J, Chen H, Mohan D, Peck MC; COVID-astegolimab-interleukin (IL) (COVASTIL) Study Group. Astegolimab or Efmarodocokin Alfa in Patients With Severe COVID-19 Pneumonia: A Randomized, Phase 2 Trial. Crit Care Med. 2023 Jan 1;51(1):103-116. doi: 10.1097/CCM.0000000000005716. Epub 2022 Nov 14.

ID	Title	Description
FG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 16, 2020	Dec 16, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28

The time to recovery was defined as the time from baseline to a clinical status score of 1 or 2 on the 7-category ordinal scale (whichever occurs first); clinical status scores are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death.

Modified Intent-to-Treat (mITT) Population: all participants randomized in the study who received at least one dose of study drug, with participants grouped according to the treatment assigned at randomization.

Posted

Median

95% Confidence Interval

Days

From Baseline up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Units	Counts
Participants	OG000134 OG001130 OG002132

Title

Denominators

Categories

Title	Measurements
	OG00010.0(8.0 to 14.0) OG00111.0(9.0 to 14.0) OG00210.0(8.0 to 13.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Unstratified Log Rank		0.9266	p<0.05 threshold for statistical significance	Hazard Ratio (HR)	1.01			2-Sided	95	0.75	1.36			The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.		Superiority
OG000 OG002

Secondary

Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status by Day 28

The 7 categories of the clinical status ordinal scale are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death

Posted

Median

95% Confidence Interval

Days

From Baseline up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Time to Hospital Discharge or "Ready for Discharge" by Day 28

Hospital discharge is category number 1 out of the 7 categories of the clinical status ordinal scale, and it is defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen).

Posted

Median

95% Confidence Interval

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Duration of Supplemental Oxygen by Day 28

Duration of supplemental oxygen was defined as the number of days during the 28-day treatment period when the participant is alive and receives "Supplemental Oxygen or other forms of ventilation", as recorded in the Vital Signs and Oxygen Saturation form. For each participant, the duration of multiple non-consecutive periods during which the participant received supplemental oxygen was summed. For any days prior to Day 28 where status of supplemental oxygen use was missing, the last known status was to be carried forward.

Posted

Median

95% Confidence Interval

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Percentage of Participants Alive and Free of Respiratory Failure by Day 28

Respiratory failure was defined as requiring non-invasive ventilation, high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]).

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Clinical Status Score at Day 14, Assessed Using a 7-Category Ordinal Scale

The clinical status scores of the 7 category ordinal scale are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death

Posted

Median

Inter-Quartile Range

Score on a scale

Day 14

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001

Secondary

Clinical Status Score at Day 28, Assessed Using a 7-Category Ordinal Scale

Posted

Median

Inter-Quartile Range

Score on a scale

Day 28

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001

Secondary

Percentage of Participants Needing Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Day 28

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A

Secondary

Number of Ventilator-Free Days by Day 28

The number of ventilator-free days was defined as the number of days during the 28-day treatment period when the participant is alive and without need for invasive mechanical ventilation. For any day during Day 1 and Day 28, if invasive mechanical ventilation or ECMO was recorded for any part of the day ( >= 12 hours during mechanical invasive ventilation for patients with tracheostomy), the day was not to be counted as a ventilator-free day; otherwise, the day was to be counted. For any days prior to Day 28 where status of mechanical ventilator was missing, the last known status was to be carried forward. The total number of days was the sum of all ventilator-free days, regardless of whether the days occurred consecutively or in nonconsecutive intervals.

Posted

Median

Inter-Quartile Range

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001

Secondary

Percentage of Participants With an Intensive Care Unit (ICU) Stay by Day 28

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A

Secondary

Duration of Intensive Care Unit (ICU) Stay by Day 28

Duration of ICU stay was calculated as the total number of hours (expressed in days) spent in ICU up to and inclusive of 28 days. ICU duration was derived from the ICU Stay Information Log using the difference between ICU discharge date/time and ICU admission date/time. If ICU admission occurred before randomization, the ICU duration was to be counted from the date of dosing. Partial admission and discharge date/time were to be imputed following a conservative approach. For each participant, durations of multiple ICU stays were to be summed.

Posted

Median

95% Confidence Interval

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Time to Clinical Failure by Day 28, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First)

Posted

Median

Inter-Quartile Range

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A

Secondary

Percentage of Participants Who Died by Day 14

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Day 14

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Percentage of Participants Who Died by Day 28

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Day 28

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG002	UTTR1147A	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) Aggregate Score of ≤2 Maintained for 24 Hours

The National Early Warning Score 2 (NEWS2) is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside. Its purpose is to identify acutely ill patients. The NEWS2 scoring system measures 7 physiological parameters: respiration rate, peripheral capillary oxygen saturation, breathing air or supplementary oxygen, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, and body temperature. A score of 0, 1, 2, or 3 is allocated to each parameter (except for air or oxygen, with respective scores of 0 and 2); a higher score means the parameter is further from the normal range. The scores for each parameter are then summed (with an aggregate score ranging from 0 to 20), and a higher aggregate score indicates a worse clinical condition of the patient, thus indicating the need for a more urgent clinical response.

Posted

Median

95% Confidence Interval

Days

Up to 28 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Safety Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

The terms "severe" and "serious" are not synonymous with respect to an adverse event (AE). Severity refers to the intensity of an AE (rated according to NCI-CTCAE v5.0 criteria or, if not listed, the following scale: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard SAE criteria), such as a life-threatening or fatal AE or an AE that prolongs inpatient hospitalization. Severity and seriousness were independently assessed by the investigator for each AE that was recorded. The investigator also assessed each AE for whether the event was considered to be related to the study drug.

Safety Population: participants who received at least one dose of study drug, with participants grouped according to the treatment received.

Posted

Count of Participants

Participants

From Baseline until study completion/discontinuation (up to 60 days)

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Number of Participants With Clinical Laboratory Test Abnormalities by Highest NCI-CTCAE Grade Post-Baseline

Clinical laboratory tests were performed over the course of the study and the grading of any abnormal values outside of the normal range (High or Low) was based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0); the higher the grade, the greater the lab parameter deviated from the normal range. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase; INR = international normalized ratio; aPTT = activated partial thromboplastin time

Safety Population: participants who received at least one dose of study drug, with participants grouped according to the treatment received. Only participants with both a baseline assessment and at least one post-baseline assessment per parameter were included in the analysis.

Posted

Count of Participants

Participants

From Baseline up to 60 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Number of Participants With Vital Sign Abnormalities at Anytime Post-Baseline

The number of participants with vital sign abnormalities outside of the normal upper (i.e., High) and lower limits (i.e., Low) were summarized for each parameter. The normal reference range used for each vital sign parameter was as follows: Diastolic Blood Pressure, 50-90 millimetres of mercury (mmHg); Oxygen Saturation, ≥94%; Pulse Rate, 60-100 beats per minute; Respiratory Rate, 8-20 breaths per minute; Systolic Blood Pressure, 90-140 mmHg; Temperature, 36.5-38 degrees Celsius (C). Not every vital sign abnormality qualified as an adverse event. A vital sign result was to be reported as an adverse event if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgement.

Posted

Count of Participants

Participants

From Baseline up to 60 days

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Number of Participants by the Investigator's Interpretations of Electrocardiogram Recordings at Specified Timepoints

Electrocardiogram (ECG) recordings were to be performed after the participant had been resting in a supine position for at least 10 minutes if possible. The investigator's interpretation of the ECG (e.g., normal or abnormal) was recorded.

Safety Population: participants who received at least one dose of study drug, with participants grouped according to the treatment received. Only participants with nonmissing assessments at a given timepoint were included in the analysis.

Posted

Count of Participants

Participants

Baseline, Days 14 and 28, Discharge Day (up to Day 28), and Study Completion Visit (up to Day 60)

ID	Title	Description
OG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Percentage of Participants Who Tested Positive for Anti-Drug Antibodies (ADAs) to MSTT1041A and UTTR1147A at Baseline and at Anytime Post-Baseline

Serum samples were collected, and participants who received treatment with MSTT1041A or MSTT1041A-matched placebo were assessed for antidrug antibodies (ADAs) to MSTT1041A, while those who received UTTR1147A or UTTR1147A-matched placebo were assessed for ADAs to UTTR1147A. Participants who received placebo treatment were only assessed for the presence of ADAs at baseline. The percentage of ADA-positive participants at baseline (baseline prevalence) and after drug administration (postbaseline incidence) are summarized. When determining postbaseline incidence, participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response).

The immunogenicity analysis population consisted of all participants with an evaluable baseline ADA sample and/or at least one evaluable post-baseline ADA sample. Participants who received placebo treatment were only assessed for the presence of ADAs at baseline.

Posted

Number

Percentage of participants

At Baseline (pre-dose on Day 1) and post-baseline (Days 15 and 28; and discharge day and study completion [up to 60 days])

ID	Title	Description
OG000	MSTT1041A-Matched Placebo	Participants in this analysis group received treatment with MSTT1041A-matched placebo. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Serum Concentration of UTTR1147A at Specified Timepoints

The Pharmacokinetics (PK) analysis population for UTTR1147A consisted of participants who received at least one dose of UTTR1147A and had at least one evaluable PK concentration data point. The PK analysis population is further divided into three groups: participants who only received the first dose, participants who received both doses, and all participants who received the first dose only or both doses (from Days 1 to 15).

Posted

Mean

Standard Deviation

nanograms per millilitre (ng/mL)

For the first dose: at 0.5 hours post-dose on Day 1, on Days 2, 3, 7, and 15; and for the second dose: Days 15 (0.5 hours post-dose), 21, and 28

ID	Title	Description
OG000	UTTR1147A - PK Participants Who Only Received First Dose	All participants in this analysis group only received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	UTTR1147A - PK Participants Who Received Both Doses	All participants in this analysis group received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1 and a second IV dose of UTTR1147A 90 μg/kg on Day 15 because they remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Secondary

Serum Concentration of MSTT1041A at Specified Timepoints

The Pharmacokinetics (PK) analysis population for MSTT1041A consisted of participants who received at least one dose of MSTT1041A and had at least one evaluable PK concentration data point. The PK analysis population is further divided into three groups: participants who only received the first dose, participants who received both doses, and all participants who received the first dose only or both doses (from Days 1 to 15).

Posted

Mean

Standard Deviation

micrograms per millilitre (μg/mL)

For the first dose: at 0.5 hours post-dose on Day 1, on Days 2, 3, 7, and 15; and for the second dose: Days 15 (0.5 hours post-dose), 21, and 28

ID	Title	Description
OG000	MSTT1041A - PK Participants Who Only Received First Dose	All participants in this analysis group only received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
OG001	MSTT1041A - PK Participants Who Received Both Doses	All participants in this analysis group received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1 and a second IV dose of MSTT1041A 350 mg was given on Day 15 because they remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0012 events2 affected130 at risk EG0020 events0 affected132 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0013 events3 affected130 at risk EG0020 events0 affected132 at risk
Cardiac arrest	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0011 events1 affected130 at risk EG0022 events2 affected132 at risk
Cardiac failure	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0006 events5 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Left ventricular failure	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0012 events2 affected130 at risk EG0020 events0 affected132 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0022 events2 affected132 at risk
Ill-defined disorder	General disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0012 events2 affected130 at risk EG0021 events1 affected132 at risk
Liver injury	Hepatobiliary disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Bacillus bacteraemia	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Bacteraemia	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
COVID-19	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0013 events3 affected130 at risk EG0021 events1 affected132 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0005 events5 affected134 at risk EG0017 events7 affected130 at risk EG0025 events5 affected132 at risk
Candida sepsis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Cellulitis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0022 events2 affected132 at risk
Device related sepsis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Orchitis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0013 events3 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Pulmonary sepsis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0003 events2 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Sepsis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0022 events2 affected132 at risk
Septic shock	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0003 events3 affected134 at risk EG0013 events3 affected130 at risk EG0024 events4 affected132 at risk
Superinfection bacterial	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0022 events2 affected132 at risk
Urosepsis	Infections and infestations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Hepatic enzyme increased	Investigations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Liver function test increased	Investigations	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Oxygen saturation decreased	Investigations	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Confusional state	Psychiatric disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0021 events1 affected132 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0012 events2 affected130 at risk EG0023 events3 affected132 at risk
Haematuria	Renal and urinary disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Renal failure	Renal and urinary disorders	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0010 events0 affected130 at risk EG0022 events2 affected132 at risk
Renal impairment	Renal and urinary disorders	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0011 events1 affected130 at risk EG0021 events1 affected132 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0022 events2 affected132 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0024 events4 affected132 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0012 events2 affected130 at risk EG0023 events3 affected132 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0021 events1 affected132 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0006 events5 affected134 at risk EG0013 events2 affected130 at risk EG0020 events0 affected132 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0003 events3 affected134 at risk EG0011 events1 affected130 at risk EG0022 events2 affected132 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0012 events1 affected130 at risk EG0021 events1 affected132 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Systematic Assessment	EG0005 events5 affected134 at risk EG0014 events4 affected130 at risk EG0022 events2 affected132 at risk
Distributive shock	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Hypertension	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0001 events1 affected134 at risk EG0010 events0 affected130 at risk EG0020 events0 affected132 at risk
Hypotension	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0002 events2 affected134 at risk EG0012 events2 affected130 at risk EG0022 events2 affected132 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0010 events0 affected130 at risk EG0021 events1 affected132 at risk
Shock	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0021 events1 affected132 at risk
Shock haemorrhagic	Vascular disorders	MedDRA v23.1	Systematic Assessment	EG0000 events0 affected134 at risk EG0011 events1 affected130 at risk EG0020 events0 affected132 at risk

ID	Title	Description
BG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
BG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
BG002	UTTR1147A	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All Placebo	Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	23	134	38	134	29	134
EG001	MSTT1041A	Participants randomized to this arm received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	23	130	38	130	42	130
EG002	UTTR1147A	Participants randomized to this arm received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.	21	132	34	132	40	132