<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408183</url>
  </required_header>
  <id_info>
    <org_study_id>T2R-002</org_study_id>
    <nct_id>NCT04408183</nct_id>
  </id_info>
  <brief_title>GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)</brief_title>
  <official_title>Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GeneOne Life Science, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GeneOne Life Science, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will evaluate the safety, tolerability and effectiveness of topical&#xD;
      GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase II randomized, placebo-controlled, double-blind study will assess whether topical&#xD;
      GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of&#xD;
      confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo&#xD;
      group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer&#xD;
      study drug three times daily for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No longer enrolling&#xD;
  </why_stopped>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">January 10, 2023</completion_date>
  <primary_completion_date type="Actual">January 10, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>4 weeks of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group</measure>
    <time_frame>4 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.</measure>
    <time_frame>4 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>GLS-1200</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mL of GLS-1200 per nostril, TID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9 %Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 mL of 0.9% Saline per nostril, TID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLS-1200</intervention_name>
    <description>GLS-1200 is given as a nasal spray using an atomizer</description>
    <arm_group_label>GLS-1200</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is given as a nasal spray using an atomizer</description>
    <arm_group_label>0.9 %Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able and willing to comply with study procedures&#xD;
&#xD;
          -  Able and willing to utilize an approved form of pregnancy prevention for women of&#xD;
             child bearing potential through to the end of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Know allergy to quinine, quinidine, or mefloquine&#xD;
&#xD;
          -  Confirmed prior positive test for SARS-CoV-2&#xD;
&#xD;
          -  Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir&#xD;
&#xD;
          -  Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding&#xD;
             or plans to become pregnant during the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sinus and Nasal Specialists of Louisiana</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Conroe Willis Medical Reasearch</name>
      <address>
        <city>Conroe</city>
        <state>Texas</state>
        <zip>77304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>February 18, 2023</last_update_submitted>
  <last_update_submitted_qc>February 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408183
org study id: T2R-002
nct id: NCT04408183
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
time frame: 4 weeks of treatment
measure: Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
time frame: 4 weeks of treatment
measure: 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
arm group label: GLS-1200
arm group type: Experimental
description: 1 mL of GLS-1200 per nostril, TID
arm group label: 0.9 %Saline
arm group type: Placebo Comparator
description: 1 mL of 0.9% Saline per nostril, TID
intervention type: Drug
intervention name: GLS-1200
description: GLS-1200 is given as a nasal spray using an atomizer
arm group label: GLS-1200
intervention type: Drug
intervention name: Placebo
description: Placebo is given as a nasal spray using an atomizer
arm group label: 0.9 %Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19