GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SARS-CoV 2, Infection

Intervention / Treatment
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* Drug: GLS-1200
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLS-1200<br>1 mL of GLS-1200 per nostril, TID | Drug: GLS-1200<br>* GLS-1200 is given as a nasal spray using an atomizer<br>|
| Placebo Comparator: 0.9 %Saline<br>1 mL of 0.9% Saline per nostril, TID | Drug: Placebo<br>* Placebo is given as a nasal spray using an atomizer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome. |  | 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19