- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408183
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
- Name: Medical Monitor
- Phone Number: 610-707-5671
- Email: jmaslow@genels.us
Study Contact Backup
- Name: Project Manager
- Email: dkane@genels.us
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T2R-002
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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