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.
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.
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
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
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