NCT04408183

GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)

Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

Detailed description

This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.

Conditions

• SARS-CoV 2
• Infection

Interventions

Type	Name	Description
DRUG	GLS-1200	GLS-1200 is given as a nasal spray using an atomizer
DRUG	Placebo	Placebo is given as a nasal spray using an atomizer

Timeline

• Start date: 2020-06-10
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2020-05-29
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study