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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2023-01-10

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.

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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.

Conditions

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SARS-CoV 2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GLS-1200

1 mL of GLS-1200 per nostril, TID

Group Type EXPERIMENTAL

GLS-1200

Intervention Type DRUG

GLS-1200 is given as a nasal spray using an atomizer

0.9 %Saline

1 mL of 0.9% Saline per nostril, TID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is given as a nasal spray using an atomizer

Interventions

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GLS-1200

GLS-1200 is given as a nasal spray using an atomizer

Intervention Type DRUG

Placebo

Placebo is given as a nasal spray using an atomizer

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes