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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.
 
ClinicalTrials.gov Identifier: NCT04408183
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0 [ Time Frame: 4 weeks of treatment ]
  • Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group [ Time Frame: 4 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)		 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19) in Health Care Personnel
Official Title  ICMJE Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection in Healthcare Personnel
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV 2
  • Infection
Intervention  ICMJE
  • Drug: GLS-1200
    GLS-1200 is given as a nasal spray using an atomizer
  • Drug: Placebo
    Placebo is given as a nasal spray using an atomizer
Study Arms  ICMJE
  • Experimental: GLS-1200
    1 mL of GLS-1200 per nostril, TID
    Intervention: Drug: GLS-1200
  • Placebo Comparator: 0.9 %Saline
    1 mL of 0.9% Saline per nostril, TID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)		 225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Medical Monitor 610-707-5671 jmaslow@geneonels-us.com
Contact: Project Manager cremigio@geneonels-us.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04408183
Other Study ID Numbers  ICMJE T2R-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeneOne Life Science, Inc.
Study Sponsor  ICMJE GeneOne Life Science, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GeneOne Life Science, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP