COVID-19 related lung disease
Conditions
Interventions
Half of the group wil receive a single IV injection with otilimab 90 mg, the
other half will receive a single IV injection with placebo.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: PART 1 - Males and Females >= 18 and = 70 years old - Positive SARS-CoV-2 result AND Hospitalized due to diagnosis of pneumonia AND Developing new onset of oxygenation impairment AND Increased biological biomakers See protocol section 5.1; page 26 and 27 for details.
Exclusion criteria
Exclusion criteria: Part 1 - Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. - Multiple organ failure according to the investigator*s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU. - Extracorporeal membrane oxygenation (ECMO) or hemofiltration/dialysis, or high-dose (>0.15*g/kg/min) noradrenaline (or equivalent) or more than one vasopressor. - Current serious or uncontrolled medical condition - Untreated infection (other than SARS-Cov-2) - Known Positive TB, HIV, hepatitis B or C test - Received monoclonal antibody therapy within the past 3 months prior to randomization - Received immunosuppressant therapy - History of allergic reaction - Currently receiving chronic oral corticosteroids 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 - Pregnancy or breastfeeding See protocol section 5.2; page 28 and 29 for details Part 2 - Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. - Multiple organ failure according to the investigator*s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU. - Extracorporeal membrane oxygenation (ECMO) or hemofiltration/dialysis, or more than one inotrope/vasopressor of any class. - Current serious or uncontrolled medical condition - Untreated infection (other than SARS-Cov-2) - Known Positive TB, HIV, hepatitis B or C test - Received monoclonal antibody therapy within the past 3 months prior to randomization - Received immunosuppressant therapy - History of allergic reaction - Currently receiving chronic oral corticosteroids 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 See protocol section 5.2; page 28 and 29 for details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants alive and free of respiratory failure at Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 All-cause mortality at Day 60 Time to All-cause mortality up to Day 60 Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 Time to recovery from respiratory failure up to Day 28 Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 Time to last dependence on supplementary oxygen up to Day 28 ICU admission Admission to ICU to day 28 Time to final ICU discharge up to Day 28 Time to final hospital discharge up to day 28 Occurrence of adverse events (up to Day 60) Occurrence of serious adverse events (up to Day 60) See protocol paragraph 3, page 21 for complete list. Part 2 All-cause mortality at Day 28 All-cause mortality at Day 60 Time to All-cause mortality up to Day 60 Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 Time to recovery from respiratory failure up to Day 28 Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 Time to last dependence on supplementary oxygen up to Day 28 ICU admission Admission to ICU to day 28 Time to final ICU discharge up to Day 60 Time to final hospital discharge up to day 60 Occurrence of adverse events (up to Day 60) Occurrence of serious adverse events (up to Day 60) See protocol paragraph 3, page 21 for complete list. | — |
Countries
Netherlands
Outcome results
None listed