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

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.

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