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OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Participants receiving otilimab | Experimental | Participants (age >=18 years and <=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1. |
|
| Part 1: Participants receiving placebo 1 | Placebo Comparator | Participants (age >=18 years and <=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1. |
|
| Part 2: Participants receiving otilimab | Experimental | Participants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2. |
|
| Part 2: Participants receiving placebo 2 | Placebo Comparator | Participants (age 70 years or above) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otilimab | Biological | Otilimab will be administered once via IV route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28 | 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. | At Day 28 |
| Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 28 | 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. | At Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Who Died Due to All Causes at Day 60 | Number of participants who died due to all causes at Day 60 are reported. | At Day 60 |
| Part 2: Number of Participants Who Died Due to All Causes at Day 28 |
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Inclusion criteria for Part 1:
Participants aged >=18 years and <=79 years at the time of obtaining informed consent.
Participants must:
have positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) result (any validated test, for example. reverse transcription polymerase chain reaction [RT-PCR] [performed on an appropriate specimen; for example: respiratory tract sample])
and be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
and be developing new onset of oxygenation impairment requiring any of the following:
and have increased biological markers of systemic inflammation (either C-reactive protein [CRP] >upper limit of normal [ULN] or serum ferritin >ULN).
No gender restriction.
Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding or if she is using highly effective contraceptive methods. Women of non-childbearing potential can also participate. A negative highly sensitive pregnancy test at hospital admission or before the first dose of study intervention.
Capable of giving written informed consent.
Inclusion Criteria for Part 2:
Participants aged 70 years or above at the time of obtaining informed consent.
Participants must:
have positive SARS-CoV-2 result (any validated test, for example. RT-PCR [performed on an appropriate specimen; for example. respiratory tract sample])
and be hospitalized due to diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19).
and be developing new onset of oxygenation impairment requiring any of the following:
and have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN.
No gender restriction.
Capable of giving written informed consent.
Exclusion Criteria for Part 1:
Exclusion Criteria for Part 2:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36229048 | Background | Patel J, Bass D, Beishuizen A, Bocca Ruiz X, Boughanmi H, Cahn A, Colombo H, Criner GJ, Davy K, de-Miguel-Diez J, Doreski PA, Fernandes S, Francois B, Gupta A, Hanrott K, Hatlen T, Inman D, Isaacs JD, Jarvis E, Kostina N, Kropotina T, Lacherade JC, Lakshminarayanan D, Martinez-Ayala P, McEvoy C, Meziani F, Monchi M, Mukherjee S, Munoz-Bermudez R, Neisen J, O'Shea C, Plantefeve G, Schifano L, Schwab LE, Shahid Z, Shirano M, Smith JE, Sprinz E, Summers C, Terzi N, Tidswell MA, Trefilova Y, Williamson R, Wyncoll D, Layton M. A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR). Eur Respir J. 2023 Feb 2;61(2):2101870. doi: 10.1183/13993003.01870-2021. Print 2023 Feb. |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 (Up to Day 60) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2021 | Mar 22, 2022 |
Participants will be randomized to receive either a blinded IV infusion of otilimab or placebo, in addition to standard of care.
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This is a double-blind study.
| Placebo 1 | Biological | Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route. |
|
| Placebo 2 | Biological | Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route. |
|
| Standard of care | Drug | All participants will receive standard of care as per institutional protocol. |
|
Number of participants who died due to all causes at Day 28 is reported
| At Day 28 |
| Part 2: Number of Participants Who Died Due to All Causes at Day 60 | Number of participants who died due to all causes at Day 60 is reported | At Day 60 |
| Part 1: Time to Death Due to All Causes up to Day 60 | 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. | Up to Day 60 |
| Part 2: Time to Death Due to All Causes up to Day 60 | 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. | Up to Day 60 |
| Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 7 | 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. | At Day 7 |
| Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 14 | 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. | At Day 14 |
| Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 42 | 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. | At Day 42 |
| Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 60 | 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. | At Day 60 |
| Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 7 | 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. | At Day 7 |
| Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 14 | 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. | At Day 14 |
| Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 42 | 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. | At Day 42 |
| Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 60 | 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. | At Day 60 |
| Part 1: Time to Recovery From Respiratory Failure up to Day 28 | 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. | Up to Day 28 |
| Part 2: Time to Recovery From Respiratory Failure up to Day 28 | 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. | Up to Day 28 |
| Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7 | 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. | At Day 7 |
| Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14 | 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. | At Day 14 |
| Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28 | 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. | At Day 28 |
| Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42 | 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. | At Day 42 |
| Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60 | 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. | At Day 60 |
| Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7 | 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. | At Day 7 |
| Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14 | 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. | At Day 14 |
| Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28 | 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. | At Day 28 |
| Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42 | 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. | At Day 42 |
| Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60 | 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. | At Day 60 |
| Part 1: Time to Last Dependence on Supplementary Oxygen | 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. | Up to Day 28 |
| Part 2: Time to Last Dependence on Supplementary Oxygen | 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. | Up to Day 28 |
| Part 1: Percentage of Participants Admitted to Intensive Care Unit (ICU) up to Day 28 | Participants who were admitted to the ICU up to (and including) Day 28 were evaluated. Percentage values are rounded off. | Up to Day 28 |
| Part 1: Time to Final ICU Discharge | 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. | Up to Day 28 |
| Part 2: Time to Final ICU Discharge | 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. | Up to Day 28 |
| Part 1: Time to First Discharge From Investigator Site up to Day 60 | 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. | Up to Day 60 |
| Part 1: Time to First Discharge to Non-hospitalized Residence up to Day 60 | 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. | Up to Day 60 |
| Part 2: Time to First Discharge From Investigator Site up to Day 60 | 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. | Up to Day 60 |
| Part 2: Time to First Discharge to Non-hospitalized Residence | 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. | Up to Day 60 |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) | 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. | Up to Day 60 |
| Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs | 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. | Up to Day 60 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| GSK Investigational Site | Sacramento | California | 95819 | United States |
| GSK Investigational Site | Torrance | California | 90502 | United States |
| GSK Investigational Site | Gainesville | Florida | 32608 | United States |
| GSK Investigational Site | Winfield | Illinois | 60190 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Germantown | Maryland | 20876 | United States |
| GSK Investigational Site | Silver Spring | Maryland | 20910 | United States |
| GSK Investigational Site | Saint Louis Park | Minnesota | 55426 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216 | United States |
| GSK Investigational Site | Reno | Nevada | 89502 | United States |
| GSK Investigational Site | Buffalo | New York | 14215-1199 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28203 | United States |
| GSK Investigational Site | Toledo | Ohio | 43608 | United States |
| GSK Investigational Site | Doylestown | Pennsylvania | 18901 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Roanoke | Virginia | 24017 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53295 | United States |
| GSK Investigational Site | Munro | Buenos Aires | 1605 | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | X5000 | Argentina |
| GSK Investigational Site | Buenos Aires | 1842 | Argentina |
| GSK Investigational Site | Buenos Aires | C1039AAO | Argentina |
| GSK Investigational Site | Córdoba | 5000 | Argentina |
| GSK Investigational Site | Córdoba | X5002AOQ | Argentina |
| GSK Investigational Site | Brussels | 1090 | Belgium |
| GSK Investigational Site | Yvoir | 5530 | Belgium |
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| GSK Investigational Site | São Paulo | 01246-090 | Brazil |
| GSK Investigational Site | São Paulo | 01323903 | Brazil |
| GSK Investigational Site | São Paulo | 04037-003 | Brazil |
| GSK Investigational Site | São Paulo | 05403-010 | Brazil |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Québec | Quebec | J5R 6J5 | Canada |
| GSK Investigational Site | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| GSK Investigational Site | Santiago | 7630000 | Chile |
| GSK Investigational Site | Santiago | 8900085 | Chile |
| GSK Investigational Site | Bogotá | 111971 | Colombia |
| GSK Investigational Site | Amiens | 80054 | France |
| GSK Investigational Site | Angers | 49933 | France |
| GSK Investigational Site | Argenteuil | 95100 | France |
| GSK Investigational Site | La Roche-sur-Yon | 85925 | France |
| GSK Investigational Site | La Tronche | 38700 | France |
| GSK Investigational Site | Limoges | 87042 | France |
| GSK Investigational Site | Melun | 77000 | France |
| GSK Investigational Site | Paris | 75013 | France |
| GSK Investigational Site | Pierre-Bénite | 69495 | France |
| GSK Investigational Site | Strasbourg | 67000 | France |
| GSK Investigational Site | Strasbourg | 67098 | France |
| GSK Investigational Site | Valenciennes | 59322 | France |
| GSK Investigational Site | Aurangabad | 431001 | India |
| GSK Investigational Site | Aurangabad | 431003 | India |
| GSK Investigational Site | Hyderabad | 500018 | India |
| GSK Investigational Site | Kolkata | 700094 | India |
| GSK Investigational Site | Kolkata | 700099 | India |
| GSK Investigational Site | Mumbai | 400034 | India |
| GSK Investigational Site | Nagpur | 440003 | India |
| GSK Investigational Site | New Delhi | 110017 | India |
| GSK Investigational Site | Pune | 411001 | India |
| GSK Investigational Site | Pune | 411013 | India |
| GSK Investigational Site | Naples | Campania | 80100 | Italy |
| GSK Investigational Site | Aichi | 470-1192 | Japan |
| GSK Investigational Site | Kanagawa | 231-8682 | Japan |
| GSK Investigational Site | Kanagawa | 251-0041 | Japan |
| GSK Investigational Site | Osaka | 534-0021 | Japan |
| GSK Investigational Site | Saitama | 350-0495 | Japan |
| GSK Investigational Site | Tokyo | 113-8519 | Japan |
| GSK Investigational Site | Tokyo | 150-8935 | Japan |
| GSK Investigational Site | Tokyo | 162-8543 | Japan |
| GSK Investigational Site | Tokyo | 162-8655 | Japan |
| GSK Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| GSK Investigational Site | Mexico City | Mexico City | 14080 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64710 | Mexico |
| GSK Investigational Site | México | 14000 | Mexico |
| GSK Investigational Site | 's-Hertogenbosch | 5223 GZ | Netherlands |
| GSK Investigational Site | Breda | 4818 CK | Netherlands |
| GSK Investigational Site | Enschede | 7512 KZ | Netherlands |
| GSK Investigational Site | Nijmegen | 6532 SZ | Netherlands |
| GSK Investigational Site | Rotterdam | 3083 AN | Netherlands |
| GSK Investigational Site | Lima | Callao 2 | Peru |
| GSK Investigational Site | Lima | Lima 11 | Peru |
| GSK Investigational Site | Lima | Lima 1 | Peru |
| GSK Investigational Site | Bydgoszcz | 85-030 | Poland |
| GSK Investigational Site | Krakow | 30-688 | Poland |
| GSK Investigational Site | Poznan | 61-285 | Poland |
| GSK Investigational Site | Warsaw | 02-507 | Poland |
| GSK Investigational Site | Wroclaw | 51-149 | Poland |
| GSK Investigational Site | Barnaul | 656045 | Russia |
| GSK Investigational Site | Chelyabinsk | 454034 | Russia |
| GSK Investigational Site | Moscow | 111539 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603011 | Russia |
| GSK Investigational Site | Omsk | 644111 | Russia |
| GSK Investigational Site | Perm | 614990 | Russia |
| GSK Investigational Site | Saint Petersburg | 191104 | Russia |
| GSK Investigational Site | Ufa | 450083 | Russia |
| GSK Investigational Site | Voronezh | 394066 | Russia |
| GSK Investigational Site | Yekaterinburg | 620039 | Russia |
| GSK Investigational Site | Benoni | Gauteng | 1501 | South Africa |
| GSK Investigational Site | Johannesburg | Gauteng | 2193 | South Africa |
| GSK Investigational Site | Durban | KwaZulu-Natal | 4052 | South Africa |
| GSK Investigational Site | Panorama | 7500 | South Africa |
| GSK Investigational Site | Tygerberg | 7505 | South Africa |
| GSK Investigational Site | Worcester | 6850 | South Africa |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobregat | 08907 | Spain |
| GSK Investigational Site | Logroño | 26006 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28055 | Spain |
| GSK Investigational Site | San Sebastián de Los Reyes/Madrid | 28702 | Spain |
| GSK Investigational Site | Manchester | Greater Manchester | M13 9WL | United Kingdom |
| GSK Investigational Site | Newcastle | Northumberland | NE2 4HH | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8XP | United Kingdom |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Part 2 (Up to Day 60) |
|
|
Baseline characteristics were presented for Enrolled Population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28 | 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. | 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. | Posted | Number | Percentage of participants | At Day 28 |
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| Primary | Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 28 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 28 |
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| Secondary | Part 1: Number of Participants Who Died Due to All Causes at Day 60 | Number of participants who died due to all causes at Day 60 are reported. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | At Day 60 |
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| Secondary | Part 2: Number of Participants Who Died Due to All Causes at Day 28 | Number of participants who died due to all causes at Day 28 is reported | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | At Day 28 |
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| Secondary | Part 2: Number of Participants Who Died Due to All Causes at Day 60 | Number of participants who died due to all causes at Day 60 is reported | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | At Day 60 |
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| Secondary | Part 1: Time to Death Due to All Causes up to Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
|
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| Secondary | Part 2: Time to Death Due to All Causes up to Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
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| Secondary | Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 7 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 7 |
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| Secondary | Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 14 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 14 |
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| Secondary | Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 42 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 42 |
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| Secondary | Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 60 |
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| Secondary | Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 7 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 7 |
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| Secondary | Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 14 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 14 |
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| Secondary | Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 42 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 42 |
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| Secondary | Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 60 |
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| Secondary | Part 1: Time to Recovery From Respiratory Failure up to Day 28 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 2: Time to Recovery From Respiratory Failure up to Day 28 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 7 |
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| Secondary | Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 14 |
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| Secondary | Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 28 |
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| Secondary | Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 42 |
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| Secondary | Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 60 |
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| Secondary | Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 7 |
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| Secondary | Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 14 |
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| Secondary | Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 28 |
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| Secondary | Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 42 |
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| Secondary | Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | At Day 60 |
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| Secondary | Part 1: Time to Last Dependence on Supplementary Oxygen | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 2: Time to Last Dependence on Supplementary Oxygen | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 1: Percentage of Participants Admitted to Intensive Care Unit (ICU) up to Day 28 | Participants who were admitted to the ICU up to (and including) Day 28 were evaluated. Percentage values are rounded off. | 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. | Posted | Number | Percentage of participants | Up to Day 28 |
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| Secondary | Part 1: Time to Final ICU Discharge | 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. | 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. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 2: Time to Final ICU Discharge | 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. | mITT Population admitted to ICU at Baseline. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 28 |
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| Secondary | Part 1: Time to First Discharge From Investigator Site up to Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
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| Secondary | Part 1: Time to First Discharge to Non-hospitalized Residence up to Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
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| Secondary | Part 2: Time to First Discharge From Investigator Site up to Day 60 | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
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| Secondary | Part 2: Time to First Discharge to Non-hospitalized Residence | 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. | mITT Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Inter-Quartile Range | Days | Up to Day 60 |
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| Secondary | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) | 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. | Safety population comprised of all participants who received study intervention | Posted | Count of Participants | Participants | Up to Day 60 |
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| Secondary | Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs | 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. | Safety population | Posted | Count of Participants | Participants | Up to Day 60 |
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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).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 93 | 403 | 147 | 396 | 97 | 396 |
| EG001 | 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. | 84 | 403 | 124 | 397 | 115 | 397 |
| EG002 | 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. | 76 | 175 | 90 | 173 | 57 | 173 |
| EG003 | 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. | 74 | 175 | 90 | 174 | 51 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia serratia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Oxygen consumption increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia acinetobacter | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia proteus | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tracheobronchitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acinetobacter sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Citrobacter infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Citrobacter sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fusobacterium infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhagic cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Homeless | Social circumstances | MedDRA 23.1 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypercapnic coma | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lactobacillus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Mycetoma mycotic | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Organic brain syndrome | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Paroxysmal atrioventricular block | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumopericardium | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Serratia bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tracheal injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Vocal cord dysfunction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2021 | Mar 22, 2022 | SAP_003.pdf |
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599766 | Otilimab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Physician Decision |
|
| Lost to Follow-up |
|
| Between 18 to 64 years |
|
| >=65 to 84 years |
|
| >=85 years |
|
| Male |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - Japanese Heritage |
|
| Asian - South East Asian Heritage |
|
| Black or African American |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Asian Race |
|
| Mixed White Race |
|
| Multiple |
|
| Unknown |
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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. |
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| Participants |
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| Units | Counts |
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