Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04376684 | Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease | PHASE2 | COMPLETED | 1,156 | — | — | May 28, 2020 | Aug 16, 2021 | Sep 23, 2024 | 120 | United States, Argentina +17 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Otilimab | BIOLOGICAL | Otilimab will be administered once via IV route. |
| Placebo 1 | BIOLOGICAL | Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route. |
| Placebo 2 | BIOLOGICAL | Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route. |
| Standard of care | DRUG | All participants will receive standard of care as per institutional protocol. |
Inclusion criteria for Part 1: * Participants aged \>=18 years and \<=79 years at the time of obtaining informed consent. * Participants must: 1. have positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) result (any validated test, for example. reverse transcription polymerase c...