<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/NCT04436458</url>
  </required_header>
  <id_info>
    <org_study_id>FW-COV-002</org_study_id>
    <nct_id>NCT04436458</nct_id>
  </id_info>
  <brief_title>Niclosamide In Moderate COVID-19</brief_title>
  <official_title>Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Wave BioPharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Wave BioPharma, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in&#xD;
      adults with moderate COVID-19 with gastrointestinal signs and symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor asset acquired by another pharma company who opened their own IND for this compound.&#xD;
    First Wave Bio never started this study in the US or ex-US.&#xD;
  </why_stopped>
  <start_date type="Actual">January 20, 2022</start_date>
  <completion_date type="Actual">January 20, 2022</completion_date>
  <primary_completion_date type="Actual">January 20, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group</measure>
    <time_frame>From Day 1 to 42</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Niclosamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continued SOC therapy together with Niclosamide tablets for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continued SOC therapy together with placebo tablets matching niclosamide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niclosamide Oral Tablet</intervention_name>
    <description>Continued SOC therapy together with niclosamide TID for 14 days</description>
    <arm_group_label>Niclosamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Continued SOC therapy together with placebo tablets matching niclosamide for 14 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are&#xD;
             expected to remain in hospital at least seven days after the randomization and who&#xD;
             accept continuing to be assessed for the study procedures (home or outpatient unit) up&#xD;
             to 6 weeks in case of discharge.&#xD;
&#xD;
          -  Patients who prior to developing COVID-19 usually have normal bowel habits defined as&#xD;
             at least 3 stools per week and no more than 3 stools per day.&#xD;
&#xD;
          -  SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before&#xD;
             randomization by local or central lab.&#xD;
&#xD;
          -  Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At the time of randomization patients requiring ICU admission or patients with severe&#xD;
             respiratory insufficiency requiring mechanical ventilation or with rapid worsening of&#xD;
             respiratory function leading to expectation for mechanical ventilation or ICU&#xD;
             admission.&#xD;
&#xD;
          -  Evidence of rapid clinical deterioration or existence of any life-threatening&#xD;
             co-morbidity or any other medical condition which, in the opinion of the investigator,&#xD;
             makes the patient unsuitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niclosamide</mesh_term>
  </intervention_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/NCT04436458
org study id: FW-COV-002
nct id: NCT04436458
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in
      adults with moderate COVID-19 with gastrointestinal signs and symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group
time frame: From Day 1 to 42
arm group label: Niclosamide
arm group type: Experimental
description: Continued SOC therapy together with Niclosamide tablets for 14 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Continued SOC therapy together with placebo tablets matching niclosamide
intervention type: Drug
intervention name: Niclosamide Oral Tablet
description: Continued SOC therapy together with niclosamide TID for 14 days
arm group label: Niclosamide
intervention type: Drug
intervention name: Placebo
description: Continued SOC therapy together with placebo tablets matching niclosamide for 14 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Niclosamide