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

Terminated
SARS-CoV 2
Infection

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

Eligibility Criteria

Inclusion Criteria:

- Age 18 or older

- Able to provide informed consent

- Able and willing to comply with study procedures

- Able and willing to utilize an approved form of pregnancy prevention for women of
child bearing potential through to the end of treatment

Exclusion Criteria:

- Know allergy to quinine, quinidine, or mefloquine

- Confirmed prior positive test for SARS-CoV-2

- Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir

- Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding
or plans to become pregnant during the course of the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, United States

University of Pennsylvania
Philadelphia, Pennsylvania, United States

Conroe Willis Medical Reasearch
Conroe, Texas, United States

GeneOne Life Science, Inc.
NCT Number
Keywords
Covid-19
MeSH Terms
Infections
Communicable Diseases
COVID-19