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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376684
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 6, 2020
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
Proportion of participants alive and free of respiratory failure at Day 28 [ Time Frame: Day 28 ]
Participants are alive and free of respiratory failure if they are 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 is 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, high-flow 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Proportion of participants alive and independent of supplementary oxygen at Day 28 [ Time Frame: Day 28 ]
Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • Number of deaths due to all causes at Day 60 [ Time Frame: Day 60 ]
    Number of deaths due to all causes will be assessed.
  • Time to number of deaths due to all causes at Day 60 [ Time Frame: Day 60 ]
    Time to death due to all causes will be assessed.
  • Proportion of participants alive and free of respiratory failure at Day 7 [ Time Frame: Day 7 ]
    Participants alive and free of respiratory failure if they are 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 is 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, high-flow 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.
  • Proportion of participants alive and free of respiratory failure at Day 14 [ Time Frame: Day 14 ]
    Participants are alive and free of respiratory failure if they are 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 is 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, high-flow 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.
  • Proportion of participants alive and free of respiratory failure at Day 42 [ Time Frame: Day 42 ]
    Participants are alive and free of respiratory failure if they are 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 is 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, high-flow 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.
  • Proportion of participants alive and free of respiratory failure at Day 60 [ Time Frame: Day 60 ]
    Participants are alive and free of respiratory failure if they are 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 is 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, high-flow 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.
  • Time to recovery from respiratory failure [ Time Frame: Day 28 ]
    Time will be recorded from dosing to recovery from respiratory failure. Participants are in respiratory failure if they are in category 5 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants alive and independent of supplementary oxygen at Day 7 [ Time Frame: Day 7 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants alive and independent of supplementary oxygen at Day 14 [ Time Frame: Day 14 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants alive and independent of supplementary oxygen at Day 28 [ Time Frame: Day 28 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants alive and independent of supplementary oxygen at Day 42 [ Time Frame: Day 42 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants alive and independent of supplementary oxygen at Day 60 [ Time Frame: Day 60 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Time to last dependence on supplementary oxygen [ Time Frame: Day 28 ]
    Time will be recorded from dosing to last dependence on supplementary oxygen. Participants are dependent on supplementary oxygen if they are in category 4 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow 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.
  • Proportion of participants admitted to Intensive Care Unit (ICU) [ Time Frame: Day 28 ]
    For participants not in ICU at time of dosing, the proportion of participants admitted to the ICU prior to Day 28.
  • Time to final Intensive Care Unit (ICU) discharge [ Time Frame: Day 28 ]
    Defined as the time from dosing to when the participant is discharged from the ICU.
  • Time to final hospital discharge [ Time Frame: Day 28 ]
    Time from dosing to when a participant is discharged from the hospital.
  • Number of participants with Adverse events (AEs) and Serious adverse events (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 treatment, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence, that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Number of deaths due to all causes at Day 60 [ Time Frame: Day 60 ]
    Number of deaths due to all causes will be assessed.
  • Time to last dependence on supplementary oxygen [ Time Frame: Day 60 ]
    Time will be recorded from dosing to last dependence on supplementary oxygen. Participants are dependent on supplementary oxygen if they are in category 4 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
  • Participants alive and independent of supplementary oxygen at Day 7 [ Time Frame: Day 7 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
  • Participants alive and independent of supplementary oxygen at Day 14 [ Time Frame: Day 14 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
  • Participants alive and independent of supplementary oxygen at Day 42 [ Time Frame: Day 42 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
  • Participants alive and independent of supplementary oxygen at Day 60 [ Time Frame: Day 60 ]
    Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is 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, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation (no additional organ support); 7) Hospitalized, mechanical ventilation plus additional organ support (e.g. vasopressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]); 8) Death.
  • Proportion of participants admitted to Intensive Care Unit (ICU) [ Time Frame: Day 28 ]
    For participants not in ICU at time of dosing, the proportion of participants admitted to the ICU prior to Day 28.
  • Time to final Intensive Care Unit (ICU) discharge [ Time Frame: Day 60 ]
    Defined as the time from dosing to when the participant is discharged from the ICU.
  • Time to final hospital discharge [ Time Frame: Day 60 ]
    Time from dosing to when a participant is discharged from the hospital.
  • Number of participants with Adverse events (AEs) and Serious adverse events (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 treatment, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence, that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease
Brief Summary This 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. Otilimab is a human monoclonal anti-GM-CSF antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of patients with severe COVID-19 related pulmonary disease. The study population will consist of hospitalized participants 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description:
This is a double-blind study.
Primary Purpose: Treatment
Condition  ICMJE Severe Acute Respiratory Syndrome
Intervention  ICMJE
  • Biological: Otilimab
    Otilimab will be administered once via IV route.
  • Biological: Placebo
    Placebo will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
  • Drug: Standard of care
    All participants will receive standard of care as per institutional protocol.
Study Arms  ICMJE
  • Experimental: Participants receiving otilimab
    Participants will receive a single dose of otilimab administered as an IV infusion in addition to standard of care.
    Interventions:
    • Biological: Otilimab
    • Drug: Standard of care
  • Placebo Comparator: Participants receiving placebo
    Participants will receive a single dose of placebo administered as an IV infusion in addition to standard of care.
    Interventions:
    • Biological: Placebo
    • Drug: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 21, 2020
Estimated Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • 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 ( e.g. 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, and one of the following conditions applies:

    1. Is a woman of non-childbearing potential (WONCBP)
    2. Or is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 60 days after the last dose of study intervention (sexual abstinence is acceptable if it is the participant's normal practice).
    3. If not consistently on a highly effective method of contraception during hospitalization, the participant must agree to a highly effective contraception plan if discharged before Day 60.
    4. The investigator should evaluate potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relation to the first dose of study intervention.
    5. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention.
    6. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Capable of giving written informed consent.

Exclusion Criteria:

  • 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 mcg/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], significant 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 HBsAg and/or anti-HCV positive.
  • Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
  • Received monoclonal antibody therapy (e.g. 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 (e.g. 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 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/minute/1.73 meter square (mL/min/m^2).
  • Pregnant or breastfeeding females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   France,   Japan,   Netherlands,   Poland,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04376684
Other Study ID Numbers  ICMJE 214094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP