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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
184
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
Number Serious Adverse Events as Assessed by CTCAE v5.0
Time frame: Through 4 weeks of treatment
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
Time frame: Through 4 weeks of treatment
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