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

September 6, 2024 updated by: GlaxoSmithKline

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • GSK Investigational Site
    • Northumberland
      • Newcastle, Northumberland, United Kingdom, NE2 4HH
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Who Died Due to All Causes at Day 60
Time Frame: 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
Time Frame: 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
Time Frame: 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 Frame: 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 Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Frame: 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 Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Frame: Up to Day 28
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 Frame: Up to Day 28
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
Time Frame: 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 Frame: Up to Day 28
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 Frame: Up to Day 28
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 Frame: 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 Frame: 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 Frame: 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 Frame: 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 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs)
Time Frame: Up to Day 60
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
Time Frame: Up to Day 60
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 214094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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