Trial intelligence / Profile preview

Sargramostim for COVID-19 Acute Hypoxic Respiratory Failure

NCT04326920Phase 4

Key facts

Status: Completed
Start: Mar 2020
Primary completion: Sep 2020
Countries: 1
Sponsor: Ghent University Hospital
Modality: Recombinant Proteins and Enzymes

Drugs: sargramostim
Conditions: coronavirus disease 2019 (COVID-19)

Overview

Phase 4, randomised, open-label trial of sargramostim in coronavirus disease 2019 (COVID-19) (2 arms), sponsored by Ghent University Hospital. Primary endpoint: Improvement in Oxygenation. Started Mar 2020; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Active sargramostim treatment group
Inhaled sargramostim 125mcg BID for 5 days + SOC
Control group
Standard of care

Who it enrols

Adult patients with confirmed COVID-19 and acute hypoxic respiratory failure (saturation <93% or PaO2/FiO2 <300), excluding those on mechanical ventilation, high dose steroids, or with active myeloid malignancy.

Endpoints

Primary

Improvement in Oxygenationhospital discharge

Secondary

Mean Change in 6-point Ordinal Scale for Clinical ImprovementDay 6
Number of Days in Hospitalthrough study completion
Number of Participants With Nosocomial Infectionup to 28 days
Death28 days
Number of Participants Progressed to Mechanical Ventilation and/or ARDSup to 28 days
Change in Clinical Sign ScoreDay 6
Change in National Early Warning Score 2Day 6
Change in Sequential Organ Failure Assessment ScoreDay 6

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