CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Sargramostim +1 moredrug
Likely dose
Sargramostim 250 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04642950
NCT04642950Phase 3Completed
CompareCT.gov

A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)

Nobelpharma·interventional·Posted Nov 24, 2020·Updated Jul 19, 2024

In Brief

A Phase 3 clinical trial evaluating Sargramostim and Placebo for COVID-19. Completed, enrolled 70 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedNov 24, 2020
Enrollment StartDec 17, 2020
Primary CompletionOct 25, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.6 years ago

Interventions

Sargramostimdrug

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.

Placebodrug

2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.