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

A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Respiratory Syndrome
• Intervention / Treatment: Biological: Otilimab; Drug: Standard of care; Biological: Placebo 1; Biological: Placebo 2

• Study Type: Interventional
• Enrollment (Actual): 1156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1842
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1039AAO
    • GSK Investigational Site
  • Cordoba, Argentina, 5000
    • GSK Investigational Site
  • Cordoba, Argentina, X5002AOQ
    • GSK Investigational Site
  • Buenos Aires
    • Munro, Buenos Aires, Argentina, 1605
      • GSK Investigational Site
  • Córdova
    • Cordoba, Córdova, Argentina, X5000
      • GSK Investigational Site
• Belgium
  • Brussel, Belgium, 1090
    • GSK Investigational Site
  • Yvoir, Belgium, 5530
    • GSK Investigational Site
• Brazil
  • São Paulo, Brazil, 01323903
    • GSK Investigational Site
  • São Paulo, Brazil, 01246-090
    • GSK Investigational Site
  • São Paulo, Brazil, 04037-003
    • GSK Investigational Site
  • São Paulo, Brazil, 05403-010
    • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • GSK Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1Y 4E9
      • GSK Investigational Site
  • Quebec
    • Montréal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • QC, Quebec, Canada, J5R 6J5
      • GSK Investigational Site
    • St-Jerome, Quebec, Canada, J7Z 5T3
      • GSK Investigational Site
• Chile
  • Santiago, Chile, 8900085
    • GSK Investigational Site
  • Santiago, Chile, 7630000
    • GSK Investigational Site
• Colombia
  • Bogotá, Colombia, 111971
    • GSK Investigational Site
• France
  • Amiens Cedex 1, France, 80054
    • GSK Investigational Site
  • Angers Cedex 9, France, 49933
    • GSK Investigational Site
  • Argenteuil, France, 95100
    • GSK Investigational Site
  • La Roche-Sur-Yon, France, 85925
    • GSK Investigational Site
  • La Tronche, France, 38700
    • GSK Investigational Site
  • Limoges Cedex, France, 87042
    • GSK Investigational Site
  • Melun, France, 77000
    • GSK Investigational Site
  • Paris, France, 75013
    • GSK Investigational Site
  • Pierre-Bénite, France, 69495
    • GSK Investigational Site
  • Strasbourg, France, 67000
    • GSK Investigational Site
  • Strasbourg cedex, France, 67098
    • GSK Investigational Site
  • Valenciennes Cedex, France, 59322
    • GSK Investigational Site
• India
  • Aurangabad, India, 431001
    • GSK Investigational Site
  • Aurangabad, India, 431003
    • GSK Investigational Site
  • Hyderabad, India, 500018
    • GSK Investigational Site
  • Kolkata, India, 700094
    • GSK Investigational Site
  • Kolkata, India, 700099
    • GSK Investigational Site
  • Mumbai, India, 400034
    • GSK Investigational Site
  • Nagpur, India, 440003
    • GSK Investigational Site
  • New Delhi, India, 110017
    • GSK Investigational Site
  • Pune, India, 411001
    • GSK Investigational Site
  • Pune, India, 411013
    • GSK Investigational Site
• Italy
  • Campania
    • Napoli, Campania, Italy, 80100
      • GSK Investigational Site
• Japan
  • Aichi, Japan, 470-1192
    • GSK Investigational Site
  • Kanagawa, Japan, 231-8682
    • GSK Investigational Site
  • Kanagawa, Japan, 251-0041
    • GSK Investigational Site
  • Osaka, Japan, 534-0021
    • GSK Investigational Site
  • Saitama, Japan, 350-0495
    • GSK Investigational Site
  • Tokyo, Japan, 162-8655
    • GSK Investigational Site
  • Tokyo, Japan, 162-8543
    • GSK Investigational Site
  • Tokyo, Japan, 113-8519
    • GSK Investigational Site
  • Tokyo, Japan, 150-8935
    • GSK Investigational Site
• Mexico
  • Mexico, Mexico, 14000
    • GSK Investigational Site
  • Ciudad De Mexico
    • Mexico City, Ciudad De Mexico, Mexico, 14080
      • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • GSK Investigational Site
• Netherlands
  • Breda, Netherlands, 4818 CK
    • GSK Investigational Site
  • Den Bosch, Netherlands, 5223 GZ
    • GSK Investigational Site
  • Enschede, Netherlands, 7512 KZ
    • GSK Investigational Site
  • Nijmegen, Netherlands, 6532 SZ
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3083 AN
    • GSK Investigational Site
• Peru
  • Lima, Peru, Lima 11
    • GSK Investigational Site
  • Lima, Peru, Lima 1
    • GSK Investigational Site
  • Lima, Peru, Callao 2
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-030
    • GSK Investigational Site
  • Krakow, Poland, 30-688
    • GSK Investigational Site
  • Poznan, Poland, 61-285
    • GSK Investigational Site
  • Warszawa, Poland, 02-507
    • GSK Investigational Site
  • Wroclaw, Poland, 51-149
    • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • GSK Investigational Site
  • Chelyabinsk, Russian Federation, 454034
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620039
    • GSK Investigational Site
  • Moscow, Russian Federation, 111539
    • GSK Investigational Site
  • Nizhniy Novgorod, Russian Federation, 603011
    • GSK Investigational Site
  • Omsk, Russian Federation, 644111
    • GSK Investigational Site
  • Perm, Russian Federation, 614990
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 191104
    • GSK Investigational Site
  • Ufa, Russian Federation, 450083
    • GSK Investigational Site
  • Voronezh, Russian Federation, 394066
    • GSK Investigational Site
• South Africa
  • Panorama,, South Africa, 7500
    • GSK Investigational Site
  • Tygerberg, South Africa, 7505
    • GSK Investigational Site
  • Worcester, South Africa, 6850
    • GSK Investigational Site
  • Gauteng
    • Benoni, Gauteng, South Africa, 1501
      • GSK Investigational Site
    • Johannesburg, Gauteng, South Africa, 2193
      • GSK Investigational Site
  • KwaZulu- Natal
    • Durban, KwaZulu- Natal, South Africa, 4052
      • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • L'Hospitalet de Llobregat, Spain, 08907
    • GSK Investigational Site
  • Logroño, Spain, 26006
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28007
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28055
    • GSK Investigational Site
  • San Sebastián De Los Reyes/Madrid, Spain, 28702
    • GSK Investigational Site
• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • GSK Investigational Site
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • GSK Investigational Site
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Sacramento, California, United States, 95819
      • GSK Investigational Site
    • Torrance, California, United States, 90502
      • GSK Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32608
      • GSK Investigational Site
  • Illinois
    • Winfield, Illinois, United States, 60190
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
    • Germantown, Maryland, United States, 20876
      • GSK Investigational Site
    • Silver Spring, Maryland, United States, 20910
      • GSK Investigational Site
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • GSK Investigational Site
    • Saint Paul, Minnesota, United States, 55101
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • GSK Investigational Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • GSK Investigational Site
  • New York
    • Buffalo, New York, United States, 14215-1199
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • GSK Investigational Site
  • Ohio
    • Toledo, Ohio, United States, 43608
      • GSK Investigational Site
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
  • Virginia
    • Roanoke, Virginia, United States, 24017
      • GSK Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • GSK Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria for Part 1:

• Participants aged >=18 years and <=79 years at the time of obtaining informed consent.

• Participants must:

  1. 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])
  2. and be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)

  3. and be developing new onset of oxygenation impairment requiring any of the following:

     1. high-flow oxygen (>=15L/min)
     2. non-invasive ventilation (for example. CPAP, BIPAP)
     3. mechanical ventilation <=48 hours prior to dose
  4. 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:

  1. have positive SARS-CoV-2 result (any validated test, for example. RT-PCR [performed on an appropriate specimen; for example. respiratory tract sample])
  2. and be hospitalized due to diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19).

  3. and be developing new onset of oxygenation impairment requiring any of the following:

     1. high-flow oxygen (>=15L/min)
     2. non-invasive ventilation (for example. CPAP, BiPAP)
     3. mechanical ventilation <=48 hours prior to dose
  4. 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:

• Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
• Multiple organ failure according to the investigator's judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
• Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis or high-dose (>0.15 micrograms [mcg]/kilograms [kg]/min) noradrenaline (or equivalent) or more than one vasopressor.
• Current serious or uncontrolled medical condition (for example: significant pulmonary disease [such as severe chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis], heart failure [New York Heart Association {NYHA} class III or higher], renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
• Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
• Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
• Known Human Immunodeficiency Virus (HIV) regardless of immunological status.
• Known hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV) positive.
• Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
• Received monoclonal antibody therapy (for examplee. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received, during the study.
• Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, Janus Kinase (JAK) inhibitors (for examplee. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study.
• History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
• Received COVID-19 convalescent plasma within 48 hours of randomization.
• Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 milligrams (mg) or equivalent per day.
• Treatment with an investigational drug within 30 days of randomization.
• Participating in other drug clinical trials, including for COVID-19.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times ULN.
• Platelets <50,000/cubic millimeters (mm^3)
• Hemoglobin <=9 grams per deciliter (g/dL)
• Absolute neutrophil count (ANC) <1.5 times 10^9/L (neutropenia >= Grade 2)
• Estimated glomerular filtration rate (GFR) <=30 milliliters (mL)/min/1.73 meter square (/m^2).
• Pregnant or breastfeeding females.

Exclusion Criteria for Part 2:

• Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
• Multiple organ failure according to the investigator's judgement or a SOFA score >10 if intubated in the ICU.
• ECMO hemofiltration/dialysis, or more than one inotrope/vasopressor of any class.
• Current serious or uncontrolled medical condition (for example. significant pulmonary disease [such as severe COPD or pulmonary fibrosis], heart failure [NYHA class III or higher], severe renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months), severe dementia, severe disability, or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
• Untreated systemic bacterial, fungal, viral, or other infection (other than SARSCoV-2).
• Known active TB, history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
• Known HIV regardless of immunological status.
• Known HBsAg and/or anti-HCV positive (participants demonstrating a sustained virologic response (SVR) are not excluded from participation).
• Currently receiving radiotherapy, chemotherapy (hormone based therapies are permitted) or immunotherapy for malignancy.
• Received monoclonal antibody therapy (for example. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received during the study.
• Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (for example. baricitinib, tofacitinib, upadacitinib), nintedanib, disease modifying antirheumatic drugs (DMARDs) (for example. methotrexate) within the last 3 months prior to randomization or planned to be received during the study.
• History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
• Received COVID-19 convalescent plasma within 48 hours of randomization.
• Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition at a dose higher than prednisone 10 mg or equivalent per day.
• Treatment with an investigational drug or substance within 30 days of randomization unless approved by the Medical Monitor.
• Participating in other drug clinical trials, including for COVID-19.
• AST or ALT >5 times ULN.
• Platelets <50,000/mm^3.
• Hemoglobin <=9 g/dL
• ANC <1.0 x 10^9/L (neutropenia >= Grade 3).
• Estimated GFR <=30 mL/min/1.73 m^2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Participants receiving otilimab; 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.	Biological: Otilimab; Otilimab will be administered once via IV route.; Drug: Standard of care; All participants will receive standard of care as per institutional protocol.
Placebo Comparator: Part 1: Participants receiving placebo 1; 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.	Drug: Standard of care; All participants will receive standard of care as per institutional protocol.; Biological: Placebo 1; Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
Experimental: Part 2: Participants receiving otilimab; 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.	Biological: Otilimab; Otilimab will be administered once via IV route.; Drug: Standard of care; All participants will receive standard of care as per institutional protocol.
Placebo Comparator: Part 2: Participants receiving placebo 2; 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.	Drug: Standard of care; All participants will receive standard of care as per institutional protocol.; Biological: Placebo 2; Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; GSK3196165; Otilimab; Ordinal scale
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 214094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No