CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 600 enrolled
Drug / intervention
Sargramostim +1 moredrug
Likely dose
Sargramostim 250 mcgfrom 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/NCT04707664
NCT04707664Phase 2Completed
CompareCT.gov

A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19

Partner Therapeutics, Inc.·interventional·Posted Jan 13, 2021·Updated Feb 6, 2023

In Brief

A Phase 2 clinical trial evaluating Sargramostim and Placebo for Covid19 and SARS-CoV Infection. Completed, enrolled 600 participants across 37 sites in 2 countries.

Detailed Summary

The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, SARS-CoV Infection
CountriesArgentina, United States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 13, 2021
Enrollment StartApr 27, 2021
Primary CompletionDec 28, 2021
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.5 years ago

Interventions

Sargramostimdrug

All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days.

Placebodrug

All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days.