Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Inhaled Sargramostim in High-risk Mild-moderate COVID-19
NCT04707664Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2021
- Primary completion
- Dec 2021
- Countries
- 2
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- sargramostim
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing Sargramostim Arm with Placebo Arm (2 arms). Primary endpoint: Number of Participants With an Emergency Room Visit or Hospitalization, or Death by Day 28. Started Apr 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sargramostim Arm
Inhaled Leukine 250 mcg daily + SOC
Placebo Arm
Inhaled Placebo daily + SOC
03
Who it enrols
Symptomatic mild or moderate COVID-19 patients with positive SARS-CoV-2 test within 5 days. Must be high risk (Age >= 60 or Age 18-59 with comorbidities like obesity, CVD, diabetes, etc.). Excludes hospitalized patients or those on chronic oxygen.
04
Endpoints
Primary
Number of Participants With an Emergency Room Visit or Hospitalization, or Death by Day 28
Secondary
Disease Progression Based on NIAID Score
Time to Disease Progression Based on NIAID Score
Change From Baseline in Overall Symptom Scores
Number of Participants With Adverse Events
Beyond the preview
Go deeper on NCT04707664.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04707664.