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

February 18, 2023 updated by: GeneOne Life Science, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Sinus and Nasal Specialists of Louisiana
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Conroe, Texas, United States, 77304
        • Conroe Willis Medical Reasearch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLS-1200
1 mL of GLS-1200 per nostril, TID
GLS-1200 is given as a nasal spray using an atomizer
Placebo Comparator: 0.9 %Saline
1 mL of 0.9% Saline per nostril, TID
Placebo is given as a nasal spray using an atomizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
Time Frame: 4 weeks of treatment
4 weeks of treatment
Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
Time Frame: 4 weeks of treatment
4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.
Time Frame: 4 weeks of treatment
4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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