Severe Acute Respiratory SyndromePhase 2OSCARNCT04376684
Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
A Phase 2 study testing Otilimab in people with Severe Acute Respiratory Syndrome, run by GlaxoSmithKline at 120 sites in 19 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome
- What is being tested?
- Otilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,156 participants
- Where
- 120 sitesin 19 countries
- Study dates
- 28 May 2020to 16 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged >=18 years and <=79 years at the time of obtaining informed consent.
- Participants must:
- have positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) result (any validated test, for example. reverse transcription polymerase chain reaction [RT-PCR] [performed on an appropriate specimen; for example: respiratory tract sample])
- and be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
- and be developing new onset of oxygenation impairment requiring any of the following:
- high-flow oxygen (>=15L/min)
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- non-invasive ventilation (for example. CPAP, BIPAP)
- mechanical ventilation <=48 hours prior to dose
- 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.
- Participants aged 70 years or above at the time of obtaining informed consent.
- Participants must:
- have positive SARS-CoV-2 result (any validated test, for example. RT-PCR [performed on an appropriate specimen; for example. respiratory tract sample])
- and be hospitalized due to diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19).
- and be developing new onset of oxygenation impairment requiring any of the following:
- high-flow oxygen (>=15L/min)
- non-invasive ventilation (for example. CPAP, BiPAP)
- mechanical ventilation <=48 hours prior to dose
- and have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN.
- No gender restriction.
- Capable of giving written informed consent.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
120 sites in 19 countries.
120 sites in 19 countries
United States21 sites
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Buffalo, New York, 14215-1199
GSK Investigational Site
Charlotte, North Carolina, 28203
GSK Investigational Site
Doylestown, Pennsylvania, 18901
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Germantown, Maryland, 20876
GSK Investigational Site
Jackson, Mississippi, 39216
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Milwaukee, Wisconsin, 53295
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Reno, Nevada, 89502
GSK Investigational Site
Roanoke, Virginia, 24017
GSK Investigational Site
Sacramento, California, 95819
GSK Investigational Site
Saint Louis Park, Minnesota, 55426
GSK Investigational Site
Saint Paul, Minnesota, 55101
GSK Investigational Site
Silver Spring, Maryland, 20910
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Toledo, Ohio, 43608
GSK Investigational Site
Torrance, California, 90502
GSK Investigational Site
Winfield, Illinois, 60190
France12 sites
GSK Investigational Site
Amiens, 80054
GSK Investigational Site
Angers, 49933
GSK Investigational Site
Argenteuil, 95100
GSK Investigational Site
La Roche-sur-Yon, 85925
GSK Investigational Site
La Tronche, 38700
GSK Investigational Site
Limoges, 87042
GSK Investigational Site
Melun, 77000
GSK Investigational Site
Paris, 75013
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Strasbourg, 67000
GSK Investigational Site
Strasbourg, 67098
GSK Investigational Site
Valenciennes, 59322
India10 sites
GSK Investigational Site
Chhatrapati Sambhajinagar, 431001
GSK Investigational Site
Chhatrapati Sambhajinagar, 431003
GSK Investigational Site
Hyderabad, 500018
GSK Investigational Site
Kolkata, 700094
GSK Investigational Site
Kolkata, 700099
GSK Investigational Site
Mumbai, 400034
GSK Investigational Site
Nagpur, 440003
GSK Investigational Site
New Delhi, 110017
GSK Investigational Site
Pune, 411001
GSK Investigational Site
Pune, 411013
Russia10 sites
GSK Investigational Site
Barnaul, 656045
GSK Investigational Site
Chelyabinsk, 454034
GSK Investigational Site
Moscow, 111539
GSK Investigational Site
Nizhny Novgorod, 603011
GSK Investigational Site
Omsk, 644111
GSK Investigational Site
Perm, 614990
GSK Investigational Site
Saint Petersburg, 191104
GSK Investigational Site
Ufa, 450083
GSK Investigational Site
Voronezh, 394066
GSK Investigational Site
Yekaterinburg, 620039
Japan9 sites
GSK Investigational Site
Aichi, 470-1192
GSK Investigational Site
Kanagawa, 231-8682
GSK Investigational Site
Kanagawa, 251-0041
GSK Investigational Site
Osaka, 534-0021
GSK Investigational Site
Saitama, 350-0495
GSK Investigational Site
Tokyo, 113-8519
GSK Investigational Site
Tokyo, 150-8935
GSK Investigational Site
Tokyo, 162-8543
GSK Investigational Site
Tokyo, 162-8655
Spain8 sites
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Logroño, 26006
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28055
GSK Investigational Site
San Sebastián de Los Reyes/Madrid, 28702
Argentina6 sites
GSK Investigational Site
Buenos Aires, 1842
GSK Investigational Site
Buenos Aires, C1039AAO
GSK Investigational Site
Córdoba, Córdoba Province, X5000
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Córdoba, X5002AOQ
GSK Investigational Site
Munro, Buenos Aires, 1605
Brazil6 sites
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130-100
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
São Paulo, 01246-090
GSK Investigational Site
São Paulo, 01323903
GSK Investigational Site
São Paulo, 04037-003
GSK Investigational Site
São Paulo, 05403-010
Canada6 sites
GSK Investigational Site
Montreal, Quebec, H4J 1C5
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Ottawa, Ontario, K1Y 4E9
GSK Investigational Site
Québec, Quebec, J5R 6J5
GSK Investigational Site
Saint-Jérôme, Quebec, J7Z 5T3
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
South Africa6 sites
GSK Investigational Site
Benoni, Gauteng, 1501
GSK Investigational Site
Durban, KwaZulu-Natal, 4052
GSK Investigational Site
Johannesburg, Gauteng, 2193
GSK Investigational Site
Panorama, 7500
GSK Investigational Site
Tygerberg, 7505
GSK Investigational Site
Worcester, 6850
Netherlands5 sites
GSK Investigational Site
's-Hertogenbosch, 5223 GZ
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Enschede, 7512 KZ
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Rotterdam, 3083 AN
Poland5 sites
GSK Investigational Site
Bydgoszcz, 85-030
GSK Investigational Site
Krakow, 30-688
GSK Investigational Site
Poznan, 61-285
GSK Investigational Site
Warsaw, 02-507
GSK Investigational Site
Wroclaw, 51-149
Mexico4 sites
GSK Investigational Site
Guadalajara, Jalisco, 44280
GSK Investigational Site
México, 14000
GSK Investigational Site
Mexico City, Mexico City, 14080
GSK Investigational Site
Monterrey, Nuevo León, 64710
Peru3 sites
GSK Investigational Site
Lima, Callao 2
GSK Investigational Site
Lima, Lima 11
GSK Investigational Site
Lima, Lima 1
United Kingdom3 sites
GSK Investigational Site
Liverpool, L7 8XP
GSK Investigational Site
Manchester, Greater Manchester, M13 9WL
GSK Investigational Site
Newcastle, Northumberland, NE2 4HH
Belgium2 sites
GSK Investigational Site
Brussels, 1090
GSK Investigational Site
Yvoir, 5530
Chile2 sites
GSK Investigational Site
Santiago, 7630000
GSK Investigational Site
Santiago, 8900085
About this study
Official title: 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.
- Conditions
- Severe Acute Respiratory Syndrome
- Being tested
- Otilimab, Placebo 1, Placebo 2, Standard of care
- Keywords
- COVID-19, Otilimab, Ordinal scale, Coronavirus, GSK3196165
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtilimabBiological
Otilimab will be administered once via IV route.
Placebo 1Biological
Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
Placebo 2Biological
Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.
Standard of careDrug
All participants will receive standard of care as per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Participants receiving otilimab | Experimental | Participants (age >=18 years and <=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1. Receives: Biological: Otilimab; Drug: Standard of care |
| Part 1: Participants receiving placebo 1 | Placebo comparator | Participants (age >=18 years and <=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1. Receives: Biological: Placebo 1; Drug: Standard of care |
| Part 2: Participants receiving otilimab | Experimental | Participants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2. Receives: Biological: Otilimab; Drug: Standard of care |
| Part 2: Participants receiving placebo 2 | Placebo comparator | Participants (age 70 years or above) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2. Receives: Biological: Placebo 2; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Day 28
Secondary outcomes (36)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start28 May 2020
- Primary completion15 Jul 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either a blinded IV infusion of otilimab or placebo, in addition to standard of care.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376684
- Sponsor's protocol ID
- 214094
- Acronym
- OSCAR
- Status last verified
- Sep 2024
- First submitted
- 4 May 2020
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
Patel J, Bass D, Beishuizen A, Bocca Ruiz X, Boughanmi H, Cahn A, Colombo H, Criner GJ, Davy K, de-Miguel-Diez J, Doreski PA, Fernandes S, Francois B, Gupta A, Hanrott K, Hatlen T, Inman D, Isaacs JD, Jarvis E, Kostina N, Kropotina T, Lacherade JC, Lakshminarayanan D, Martinez-Ayala P, McEvoy C, Meziani F, Monchi M, Mukherjee S, Munoz-Bermudez R, Neisen J, O'Shea C, Plantefeve G, Schifano L, Schwab LE, Shahid Z, Shirano M, Smith JE, Sprinz E, Summers C, Terzi N, Tidswell MA, Trefilova Y, Williamson R, Wyncoll D, Layton M. A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR). Eur Respir J. 2023 Feb 2;61(2):2101870. doi: 10.1183/13993003.01870-2021. Print 2023 Feb.
PubMed 36229048
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease
- ClinicalTrials.gov ID
- NCT04376684
- Acronym / sponsor ID
- OSCAR / 214094
- Conditions
- Severe Acute Respiratory Syndrome
- Keywords
- COVID-19, Otilimab, Ordinal scale, Coronavirus, GSK3196165
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,156 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomized to receive either a blinded IV infusion of otilimab or placebo, in addition to standard of care.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Participants receiving otilimab | Experimental | Biological: Otilimab, Drug: Standard of careParticipants (age >=18 years and <=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1. |
| Part 1: Participants receiving placebo 1 | Placebo comparator | Biological: Placebo 1, Drug: Standard of careParticipants (age >=18 years and <=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1. |
| Part 2: Participants receiving otilimab | Experimental | Biological: Otilimab, Drug: Standard of careParticipants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2. |
| Part 2: Participants receiving placebo 2 | Placebo comparator | Biological: Placebo 2, Drug: Standard of careParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Participants aged >=18 years and <=79 years at the time of obtaining informed consent.
- Participants must:
- 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.
Key exclusion criteria (43 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtilimabOtilimab will be administered once via IV route. | Biological | Part 1: Participants receiving otilimab, Part 2: Participants receiving otilimab |
| Placebo 1Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route. | Biological | Part 1: Participants receiving placebo 1 |
| Placebo 2Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route. | Biological | Part 2: Participants receiving placebo 2 |
| Standard of careAll participants will receive standard of care as per institutional protocol. | Drug | Part 1: Participants receiving otilimab, Part 1: Participants receiving placebo 1, Part 2: Participants receiving otilimab, Part 2: Participants receiving placebo 2 |
Primary outcome
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.
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.
36 secondary outcomes
Part 1: Number of Participants Who Died Due to All Causes at Day 60
Time frame: At Day 60
Part 2: Number of Participants Who Died Due to All Causes at Day 28
Time frame: At Day 28
Part 2: Number of Participants Who Died Due to All Causes at Day 60
Time frame: At Day 60
Part 1: Time to Death Due to All Causes up to Day 60
Time frame: Up to Day 60
Part 2: Time to Death Due to All Causes up to Day 60
Time frame: Up to Day 60
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 7
Time frame: At Day 7
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Time frame: At Day 14
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 42
Time frame: At Day 42
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 60
Time frame: At Day 60
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 7
Time frame: At Day 7
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Time frame: At Day 14
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 42
Time frame: At Day 42
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 60
Time frame: At Day 60
Part 1: Time to Recovery From Respiratory Failure up to Day 28
Time frame: Up to Day 28
Part 2: Time to Recovery From Respiratory Failure up to Day 28
Time frame: Up to Day 28
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7
Time frame: At Day 7
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14
Time frame: At Day 14
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28
Time frame: At Day 28
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42
Time frame: At Day 42
Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60
Time frame: At Day 60
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7
Time frame: At Day 7
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14
Time frame: At Day 14
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28
Time frame: At Day 28
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42
Time frame: At Day 42
Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60
Time frame: At Day 60
Part 1: Time to Last Dependence on Supplementary Oxygen
Time frame: Up to Day 28
Part 2: Time to Last Dependence on Supplementary Oxygen
Time frame: 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
Part 1: Time to Final ICU Discharge
Time frame: Up to Day 28
Part 2: Time to Final ICU Discharge
Time frame: Up to Day 28
Part 1: Time to First Discharge From Investigator Site up to Day 60
Time frame: Up to Day 60
Part 1: Time to First Discharge to Non-hospitalized Residence up to Day 60
Time frame: Up to Day 60
Part 2: Time to First Discharge From Investigator Site up to Day 60
Time frame: Up to Day 60
Part 2: Time to First Discharge to Non-hospitalized Residence
Time frame: 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
Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs
Time frame: Up to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36229048Patel J, Bass D, Beishuizen A, Bocca Ruiz X, Boughanmi H, Cahn A, Colombo H, Criner GJ, Davy K, de-Miguel-Diez J, Doreski PA, Fernandes S, Francois B, Gupta A, Hanrott K, Hatlen T, Inman D, Isaacs JD, Jarvis E, Kostina N, Kropotina T, Lacherade JC, Lakshminarayanan D, Martinez-Ayala P, McEvoy C, Meziani F, Monchi M, Mukherjee S, Munoz-Bermudez R, Neisen J, O'Shea C, Plantefeve G, Schifano L, Schwab LE, Shahid Z, Shirano M, Smith JE, Sprinz E, Summers C, Terzi N, Tidswell MA, Trefilova Y, Williamson R, Wyncoll D, Layton M. A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR). Eur Respir J. 2023 Feb 2;61(2):2101870. doi: 10.1183/13993003.01870-2021. Print 2023 Feb.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
120 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Otilimab in people with Severe Acute Respiratory Syndrome, run by GlaxoSmithKline at 120 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 120 sites in United States, France, India, Russia, Japan and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28 (time frame: At Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.