A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,156
- 试验地点
- 1
- 主要终点
- Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: Participants receiving otilimab
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.
干预措施: Otilimab (Biological)
Part 1: Participants receiving otilimab
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.
干预措施: Standard of care (Drug)
Part 1: Participants receiving placebo 1
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.
干预措施: Placebo 1 (Biological)
Part 1: Participants receiving placebo 1
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.
干预措施: Standard of care (Drug)
Part 2: Participants receiving otilimab
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.
干预措施: Otilimab (Biological)
Part 2: Participants receiving otilimab
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.
干预措施: Standard of care (Drug)
Part 2: Participants receiving placebo 2
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.
干预措施: Placebo 2 (Biological)
Part 2: Participants receiving placebo 2
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.
干预措施: Standard of care (Drug)
结局指标
主要结局
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28
时间窗: 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
时间窗: 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.
次要结局
- Part 2: Number of Participants Who Died Due to All Causes at Day 60(At Day 60)
- Part 1: Time to Death Due to All Causes up to Day 60(Up to Day 60)
- Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 14(At Day 14)
- Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 42(At Day 42)
- Part 1: Number of Participants Who Died Due to All Causes at Day 60(At Day 60)
- Part 2: Number of Participants Who Died Due to All Causes at Day 28(At Day 28)
- Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 7(At Day 7)
- Part 2: Time to Death Due to All Causes up to Day 60(Up to Day 60)
- Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 14(At Day 14)
- Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 42(At Day 42)
- Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 60(At Day 60)
- Part 1: Time to First Discharge From Investigator Site up to Day 60(Up to Day 60)
- Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 7(At Day 7)
- Part 1: Time to Last Dependence on Supplementary Oxygen(Up to Day 28)
- Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 60(At Day 60)
- Part 1: Time to Recovery From Respiratory Failure up to Day 28(Up to Day 28)
- Part 1: Time to First Discharge to Non-hospitalized Residence up to Day 60(Up to Day 60)
- Part 2: Time to Recovery From Respiratory Failure up to Day 28(Up to Day 28)
- Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7(At Day 7)
- Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14(At Day 14)
- Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28(At Day 28)
- Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42(At Day 42)
- Part 1: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60(At Day 60)
- Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 7(At Day 7)
- Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 14(At Day 14)
- Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 28(At Day 28)
- Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 42(At Day 42)
- Part 2: Percentage of Participants Alive and Independent of Supplementary Oxygen at Day 60(At Day 60)
- Part 2: Time to Last Dependence on Supplementary Oxygen(Up to Day 28)
- Part 1: Percentage of Participants Admitted to Intensive Care Unit (ICU) up to Day 28(Up to Day 28)
- Part 1: Time to Final ICU Discharge(Up to Day 28)
- Part 2: Time to Final ICU Discharge(Up to Day 28)
- Part 2: Time to First Discharge From Investigator Site up to Day 60(Up to Day 60)
- Part 2: Time to First Discharge to Non-hospitalized Residence(Up to Day 60)
- Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs)(Up to Day 60)
- Part 2: Number of Participants With SAEs and Common (>=5%) Non-SAEs(Up to Day 60)