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

Sponsor
GeneOne Life Science, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04408183
Collaborator
(none)
225
3
2
29.7
75
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
Actual Study Start Date :
Jun 10, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GLS-1200

1 mL of GLS-1200 per nostril, TID

Drug: GLS-1200
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

Drug: Placebo
Placebo is given as a nasal spray using an atomizer

Outcome Measures

Primary Outcome Measures

  1. Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0 [4 weeks of treatment]

  2. Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group [4 weeks of treatment]

Secondary Outcome Measures

  1. Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome. [4 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sinus and Nasal Specialists of Louisiana Baton Rouge Louisiana United States 70809
2 University of Pennsylvania Philadelphia Pennsylvania United States 19104
3 Conroe Willis Medical Reasearch Conroe Texas United States 77304

Sponsors and Collaborators

  • GeneOne Life Science, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT04408183
Other Study ID Numbers:
  • T2R-002
First Posted:
May 29, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GeneOne Life Science, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022