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

GeneOne Life Science

Status and phase: Terminated; Phase 2

Conditions: Infection; SARS-CoV 2

Treatments: Drug: GLS-1200; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04408183

T2R-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups, including a placebo group

GLS-1200

Experimental group

Description:

1 mL of GLS-1200 per nostril, TID

Treatment:

Drug: GLS-1200

0.9 %Saline

Placebo Comparator group

Description:

1 mL of 0.9% Saline per nostril, TID

Treatment:

Drug: Placebo