None listed
Conditions
Interventions
Otilimab Type of group
Participants receive a blinded 1-hour infusion of Otilimab 90 mg IV in addition to standard of care.
Group name:Otilimab placebo Type of group
Participants receive a blinded 1-hour infusion of Otilimab placebo 90 mg IV in addition to standard of care.
Sponsors
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age ≥18 years and ≤79 years 2) Have positive SARS-CoV-2 result 3) Be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan) 4) Be developing new onset of oxygenation impairment requiring any of the following: high-flow oxygen (≥15L/min); non-invasive ventilation (e.g. CPAP, iPAP); mechanical ventilation ≤48h prior to dose 5) Have increased biological markers of systemic inflammation. 6) No gender restriction 7) Female participants must meet and agree to abide by the contraceptive criteria. 8) Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures. For more details check the protocol
Exclusion criteria
Exclusion criteria: 1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor 4) Current serious or uncontrolled medical condition or abnormality of clinical 5) Untreated systemic bacterial, fungal, viral, or other infection 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB 7) Known HIV regardless of immunological status 8) Known HBsAg and/or anti-HCV positive 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy For more details check the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:To compare the efficacy of otilimab 90 mg IV versus placebo Measure:To compare the efficacy of otilimab 90 mg IV versus placebo Timepoints:28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:All-cause mortality at Day 60 Measure:All-cause mortality at Day 60 Timepoints:60 days ; Outcome name:Time to all-cause mortality up to Day 60 Measure:Time to all-cause mortality up to Day 60 Timepoints:60 days ; Outcome name:Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 Measure:Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 Timepoints:60 days ; Outcome name:Time to recovery from respiratory failure up to Day 28 Measure:Time to recovery from respiratory failure up to Day 28 Timepoints:28 days ; Outcome name:Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 Measure:Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 Timepoints:60 days ; Outcome name:Time to last dependence on supplementary oxygen up to Day 28 Measure:Time to last dependence on supplementary oxygen up to Day 28 Timepoints:28 days ; Outcome name:Admission to ICU up to Day 28 Measure:Admission to ICU up to Day 28 Timepoints:28 days ; Outcome name:Time to final ICU discharge up to Day 28 Measure:Time to final ICU discharge up to Day 28 Timepoints:28 days ; Outcome name:Time to final hospital discharge up to Day 28 Measure:Time to final hospital discharge up to Day 28 Timepoints:28 days ; Outcome name:Occurrence of adverse events (AEs) [up to Day 60] Measure:Occurrence of adverse events (AEs) [up to Day 60] Timepoints:60 days ; Outcome name:Occurrence of serious adverse events (SAEs) [up to Day 60] Measure:Occurrence of serious adverse events (SAEs) [up to Day 60] Timepoints:60 days ; Outcome name:Invasive mechanical ventilation (if not previously initiated) Measure:Invasive mechanical ventilation (if not previously initiated) Timepoints:28 days | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Colombia, France, India, Japan, Mexico, Nederland, Peru, Poland, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactJose Carlos Sandoval
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed