Trials / Completed
CompletedNCT04629703
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- Rigel Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
Detailed description
The primary objective of this study is: To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.
Conditions
- Covid19
- SARS (Severe Acute Respiratory Syndrome)
- SARS Pneumonia
- SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
- Pneumonia
- Pneumonia, Viral
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fostamatinib | Fostamatinib (150 mg twice daily) for 14 days and Standard of Care |
| DRUG | Placebo | Placebo (twice daily) for 14 days and Standard of Care |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2022-09-05
- Completion
- 2022-09-05
- First posted
- 2020-11-16
- Last updated
- 2023-08-18
Locations
47 sites across 4 countries: United States, Argentina, Brazil, Mexico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04629703. Inclusion in this directory is not an endorsement.