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NCT04376684 · ClinicalTrials.gov registry record · Phase 2
Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,156
- Enrollment target
NCT04376684: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04376684 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,156 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (769% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04376684, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,156 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Standard of care
- BIOLOGICAL Otilimab
- BIOLOGICAL Placebo 1
- BIOLOGICAL Placebo 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,156 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2021-08-16 |
| Phase | Phase 2 |
What the finished NCT04376684 record still lists
NCT04376684 is an interventional study that assigns participants to a tested intervention. Its 1,156 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (769% higher).
The record links to 0 conditions, and to 4 interventions - of which Standard of care is the first listed.
NCT04376684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04376684 about?
NCT04376684 is a clinical study titled "Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease". 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). Otilima...
What is the current status of trial NCT04376684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,156 participants. The study started on 2020-05-28. Estimated completion is 2021-08-16.
What interventions are being tested in trial NCT04376684?
The interventions under investigation include: Standard of care (DRUG), Otilimab (BIOLOGICAL), Placebo 1 (BIOLOGICAL), Placebo 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04376684?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04376684's enrollment target sits among peer trials
1,156 19th of 2000 higher than 1,982 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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