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Sargramostim Use in COVID-19 to Recover Patient Health

NCT04707664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-02-06

Study results available
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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.

Conditions

  • Covid19
  • SARS-CoV Infection

Interventions

DRUG

Sargramostim

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Partner Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Fiona Garner, PhD · Partner Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2021-12-28
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States
  • Argentina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707664 on ClinicalTrials.gov