GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GLS-1200 1 mL of GLS-1200 per nostril, TID |
Drug: GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
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Placebo Comparator: 0.9 %Saline 1 mL of 0.9% Saline per nostril, TID |
Drug: Placebo
Placebo is given as a nasal spray using an atomizer
|
Outcome Measures
Primary Outcome Measures
- Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0 [4 weeks of treatment]
- Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group [4 weeks of treatment]
Secondary Outcome Measures
- Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome. [4 weeks of treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older
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Able to provide informed consent
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Able and willing to comply with study procedures
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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:
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Know allergy to quinine, quinidine, or mefloquine
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Confirmed prior positive test for SARS-CoV-2
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Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir
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Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sinus and Nasal Specialists of Louisiana | Baton Rouge | Louisiana | United States | 70809 |
2 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
3 | Conroe Willis Medical Reasearch | Conroe | Texas | United States | 77304 |
Sponsors and Collaborators
- GeneOne Life Science, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T2R-002