NCT04590547

GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

Detailed description

This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection. Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily. Clinical status will be monitored through 56 days from the initiation of treatment.

Conditions

• Pneumonitis
• SARS-CoV Infection

Interventions

Type	Name	Description
DRUG	GLS-1027	GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
DRUG	Placebo	Placebo looks like GLS-1027

Timeline

• Start date: 2021-05-07
• Primary completion: 2022-08-14
• Completion: 2023-07-24
• First posted: 2020-10-19
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

17 sites across 5 countries: United States, Bulgaria, North Macedonia, Puerto Rico, South Korea

Regulatory

• FDA-regulated drug study