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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04408183
• Other study ID #: T2R-002
• Status: Terminated
• Phase: Phase 2
• Start date: June 10, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: GeneOne Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 184
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infection
• Infections
• SARS-CoV 2

Intervention

Drug:
• GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
• Placebo
Placebo is given as a nasal spray using an atomizer

Locations

Country	Name	City	State
United States	Sinus and Nasal Specialists of Louisiana	Baton Rouge	Louisiana
United States	Conroe Willis Medical Reasearch	Conroe	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0		4 weeks of treatment
Primary	Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group		4 weeks of treatment
Secondary	Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.		4 weeks of treatment