COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04408183
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : December 3, 2020
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

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
SARS-CoV 2 Infection Drug: GLS-1200 Drug: Placebo 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 in Healthcare Personnel
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • Adult healthcare professional
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04408183

Layout table for location contacts
Contact: Medical Monitor 610-707-5671
Contact: Project Manager

Layout table for location information
United States, Louisiana
Sinus and Nasal Specialists of Louisiana Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Brittany Zito         
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
GeneOne Life Science, Inc.
Layout table for additonal information
Responsible Party: GeneOne Life Science, Inc. Identifier: NCT04408183    
Other Study ID Numbers: T2R-002
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

Layout table for additional information
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:
Layout table for MeSH terms
Communicable Diseases