<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/NCT04445467</url>
  </required_header>
  <id_info>
    <org_study_id>66223</org_study_id>
    <nct_id>NCT04445467</nct_id>
  </id_info>
  <brief_title>An Adaptive Clinical Trial of Antivirals for COVID-19 Infection</brief_title>
  <acronym>VIRCO</acronym>
  <official_title>An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayside Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayside Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals&#xD;
      to treat COVID-19 infection compared to placebo for virological cure and improved clinical&#xD;
      outcomes. Individuals will be randomised to the candidate antiviral which in the first&#xD;
      instance is Favipiravir or matched placebo and randomisation will be stratified according to&#xD;
      whether the participant requires hospitalisation or not. This treatment will be given in&#xD;
      addition to the usual standard of care in the participating hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>Time to virological cure</measure>
    <time_frame>14 days</time_frame>
    <description>Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>28 days</time_frame>
    <description>All adverse events definitely, probably or possibly related to study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>28 days</time_frame>
    <description>Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptoms</measure>
    <time_frame>28 days</time_frame>
    <description>Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers</measure>
    <time_frame>28 days</time_frame>
    <description>Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Favipiravir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>Favipiravir</description>
    <arm_group_label>Favipiravir</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent by the participant or authorized representative&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days&#xD;
&#xD;
          -  COVID-19 related symptom initiation within 5 days&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative pregnancy test at&#xD;
             Screening. Female patients of childbearing potential and fertile male patients who are&#xD;
             sexually active with a female of childbearing potential must use highly effective&#xD;
             methods of contraception throughout the study and for 1 week following the last dose&#xD;
             of study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to the study medication&#xD;
&#xD;
          -  Is on another antiviral for the treatment of COVID-19&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh&#xD;
             classification&#xD;
&#xD;
          -  Patients with renal impairment requiring dialysis&#xD;
&#xD;
          -  Is deemed by the Investigator to be ineligible for any reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Favipiravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04445467
org study id: 66223
nct id: NCT04445467
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals
      to treat COVID-19 infection compared to placebo for virological cure and improved clinical
      outcomes. Individuals will be randomised to the candidate antiviral which in the first
      instance is Favipiravir or matched placebo and randomisation will be stratified according to
      whether the participant requires hospitalisation or not. This treatment will be given in
      addition to the usual standard of care in the participating hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to virological cure
time frame: 14 days
description: Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
measure: Safety
time frame: 28 days
description: All adverse events definitely, probably or possibly related to study treatment.
measure: Clinical improvement
time frame: 28 days
description: Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
measure: Clinical symptoms
time frame: 28 days
description: Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours
measure: Biomarkers
time frame: 28 days
description: Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
arm group label: Favipiravir
arm group type: Experimental
description: 1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matched Placebo
intervention type: Drug
intervention name: Favipiravir
description: Favipiravir
arm group label: Favipiravir
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Australia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Favipiravir
sharing ipd: Undecided