Back to resultsGLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Primary Purpose
SARS-CoV 2, Infection
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLS-1200
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV 2 focused on measuring COVID-19
Eligibility Criteria
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
Sites / Locations
- Sinus and Nasal Specialists of Louisiana
- University of Pennsylvania
- Conroe Willis Medical Reasearch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GLS-1200
0.9 %Saline
Arm Description
1 mL of GLS-1200 per nostril, TID
1 mL of 0.9% Saline per nostril, TID
Outcomes
Primary Outcome Measures
Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
Secondary Outcome Measures
Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.
Full Information
NCT ID
NCT04408183
First Posted
May 22, 2020
Last Updated
February 18, 2023
Sponsor
GeneOne Life Science, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04408183
Brief Title
GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Official Title
Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
No longer enrolling
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeneOne Life Science, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, Infection
Keywords
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLS-1200
Arm Type
Experimental
Arm Description
1 mL of GLS-1200 per nostril, TID
Arm Title
0.9 %Saline
Arm Type
Placebo Comparator
Arm Description
1 mL of 0.9% Saline per nostril, TID
Intervention Type
Drug
Intervention Name(s)
GLS-1200
Intervention Description
GLS-1200 is given as a nasal spray using an atomizer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is given as a nasal spray using an atomizer
Primary Outcome Measure Information:
Title
Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
Time Frame
4 weeks of treatment
Title
Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
Time Frame
4 weeks of treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sinus and Nasal Specialists of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Conroe Willis Medical Reasearch
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
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