Study Stopped
No longer enrolling
GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
1 other identifier
interventional
184
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
June 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedResults Posted
Study results publicly available
July 31, 2025
CompletedJuly 31, 2025
July 1, 2025
2.6 years
May 22, 2020
July 15, 2025
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number Serious Adverse Events as Assessed by CTCAE v5.0
Through 4 weeks of treatment
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
Through 4 weeks of treatment
Study Arms (2)
GLS-1200
EXPERIMENTAL1 mL of GLS-1200 per nostril, TID
0.9 %Saline
PLACEBO COMPARATOR1 mL of 0.9% Saline per nostril, TID
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, 70809, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Conroe Willis Medical Reasearch
Conroe, Texas, 77304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Clinical Operations Associate
- Organization
- GeneOne Life Science
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 29, 2020
Study Start
June 10, 2020
Primary Completion
January 10, 2023
Study Completion
January 10, 2023
Last Updated
July 31, 2025
Results First Posted
July 31, 2025
Record last verified: 2025-07