<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/NCT04464408</url>
  </required_header>
  <id_info>
    <org_study_id>RC 20/220/R</org_study_id>
    <nct_id>NCT04464408</nct_id>
  </id_info>
  <brief_title>Favipiravir Therapy in Adults With Mild COVID-19</brief_title>
  <acronym>Avi-Mild</acronym>
  <official_title>A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Abdullah International Medical Research Center</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>
      Favipiravir is a selective and potent inhibitor of inﬂuenza viral RNA polymerase. It acts as&#xD;
      a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It&#xD;
      has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially&#xD;
      novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy&#xD;
      and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases.&#xD;
      It is a Multicenter, randomized double-blinded, parallel-group trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">August 4, 2021</completion_date>
  <primary_completion_date type="Actual">August 4, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCR negative</measure>
    <time_frame>15 days</time_frame>
    <description>Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from randomization to clinical recovery</measure>
    <time_frame>15 days</time_frame>
    <description>The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate symptoms progression</measure>
    <time_frame>28 days</time_frame>
    <description>Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate Faviparivirs effect</measure>
    <time_frame>15 days</time_frame>
    <description>To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate Favipiravir's effect</measure>
    <time_frame>28 days</time_frame>
    <description>To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the safety of Favipiravir</measure>
    <time_frame>28 days</time_frame>
    <description>Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Favipiravir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily</description>
    <arm_group_label>Favipiravir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Patients must be eligible according to the following criteria for enrollment&#xD;
&#xD;
          1. Should be at least 18 years of age&#xD;
&#xD;
          2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient&#xD;
             requests or is not sure, the study team will provide it)&#xD;
&#xD;
          3. Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the&#xD;
             time of recruitment, a result within the last five days&#xD;
&#xD;
          4. Patients have to be enrolled within 5 days of disease onset.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        Patients meeting any of the following criteria will be excluded from trial enrolment:&#xD;
&#xD;
          1. Patients with concomitant documented bacterial pneumonia established through positive&#xD;
             sputum cultures&#xD;
&#xD;
          2. Patients who are pregnant or breastfeeding&#xD;
&#xD;
          3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the&#xD;
             patient previously for influenza)&#xD;
&#xD;
          4. Major comorbidities increasing the risk of study drug including&#xD;
&#xD;
               -  Hematologic malignancy&#xD;
&#xD;
               -  Advanced (stage 4-5) chronic kidney disease or dialysis therapy&#xD;
&#xD;
               -  Severe liver damage (Child-Pugh score C, AST&gt; 5 times the upper limit)&#xD;
&#xD;
               -  HIV&#xD;
&#xD;
               -  Gout/history of Gout or hyperuricemia (two times above the ULN)&#xD;
&#xD;
        (6) Having used Favipiravir or participated in any other interventional drug clinical study&#xD;
        within 30 days before the first dose of study drug (i.e., the patient received it for&#xD;
        influenza previously) (7) The investigator believes that participating in the trial is not&#xD;
        in the best interests of the patient, or the investigator considers unsuitable for&#xD;
        enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical&#xD;
        prognostic non-survival, palliative care, or in a deep coma and have no response to&#xD;
        supportive treatment within three hours of admission.&#xD;
&#xD;
        (9) Hospitalized patients for mild, moderate, or severe COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Bosaeed</last_name>
    <role>Principal Investigator</role>
    <affiliation>KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah</name>
      <address>
        <city>Al Madinah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Fahad Hospital - Madinah</name>
      <address>
        <city>Al Madīnah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Care-Safiyah</name>
      <address>
        <city>Al Madīnah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdullah Medical City - Makkah</name>
      <address>
        <city>Mecca</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdulaziz Medical City - Riyadh</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Care-Al Mansoura</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Care-Al Urijah</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Favipiravir</keyword>
  <keyword>COVID19</keyword>
  <keyword>Mild illness</keyword>
  <keyword>Saudi Arabia</keyword>
  <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>No</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/NCT04464408
org study id: RC 20/220/R
nct id: NCT04464408
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Favipiravir is a selective and potent inhibitor of inﬂuenza viral RNA polymerase. It acts as
      a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It
      has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially
      novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy
      and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases.
      It is a Multicenter, randomized double-blinded, parallel-group trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: PCR negative
time frame: 15 days
description: Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
measure: Time from randomization to clinical recovery
time frame: 15 days
description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
measure: Evaluate symptoms progression
time frame: 28 days
description: Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
measure: Evaluate Faviparivirs effect
time frame: 15 days
description: To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
measure: Evaluate Favipiravir's effect
time frame: 28 days
description: To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
measure: Evaluate the safety of Favipiravir
time frame: 28 days
description: Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects
arm group label: Favipiravir
arm group type: Experimental
description: Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)
arm group label: Placebo
arm group type: Placebo Comparator
description: 9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
intervention type: Drug
intervention name: Favipiravir
description: 1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
arm group label: Favipiravir
intervention type: Drug
intervention name: Placebo
description: (9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Mohammad Bosaeed
role: Principal Investigator
affiliation: KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Favipiravir
sharing ipd: No