Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,156 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04376684
The ClinicalTrials.gov registry entry for NCT04376684 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Standard of care is the first listed.
NCT04376684 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.