Trials / Completed
CompletedNCT04642950
A Phase II/III Study of Sargramostim
A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Nobelpharma · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sargramostim | 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes. |
| DRUG | Placebo | 2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes. |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2021-10-25
- Completion
- 2021-10-25
- First posted
- 2020-11-24
- Last updated
- 2024-07-19
- Results posted
- 2024-07-19
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04642950. Inclusion in this directory is not an endorsement.