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

Phase 2

Terminated

• Conditions: SARS-CoV 2; Infection
• Interventions: Drug: GLS-1200; Drug: Placebo

• Registration Number: NCT04408183
• Lead Sponsor: GeneOne Life Science, Inc.

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.

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 Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Study Start: 2020-06-10
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLS-1200	GLS-1200	1 mL of GLS-1200 per nostril, TID
0.9 %Saline	Placebo	1 mL of 0.9% Saline per nostril, TID

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.	4 weeks of treatment

Trial Locations

Locations (3)

Sinus and Nasal Specialists of Louisiana; 🇺🇸 Baton Rouge, Louisiana, United States

Conroe Willis Medical Reasearch; 🇺🇸 Conroe, Texas, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States