GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Purpose
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.
Conditions
- SARS-CoV 2
- Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GLS-1200 |
1 mL of GLS-1200 per nostril, TID |
|
|
Placebo Comparator 0.9 %Saline |
1 mL of 0.9% Saline per nostril, TID |
|
Recruiting Locations
More Details
- NCT ID
- NCT04408183
- Status
- Terminated
- Sponsor
- GeneOne Life Science, Inc.
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.