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GLS-1200Topical 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 : June 4, 2020
Sponsor:
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.

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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 : September 2020
Estimated Study Completion Date : November 2020

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Able to provide informed consent
  • Able and willing to comply with study procedures
  • Adult healthcare professional

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

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 ClinicalTrials.gov identifier (NCT number): NCT04408183


Contacts
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Contact: Medical Monitor 484-965-9147 jmaslow@geneonels-us.com
Contact: Project Manager cremigio@geneonels-us.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rupa Chowdary    215-573-5073    Rupa.Chowdary@pennmedicine.upenn.edu   
Sponsors and Collaborators
GeneOne Life Science, Inc.
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Responsible Party: GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier: NCT04408183    
Other Study ID Numbers: T2R-002
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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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.:
COVID-19
Additional relevant MeSH terms:
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Infection
Communicable Diseases