<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/NCT04474457</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19-PMS-FAV</org_study_id>
    <nct_id>NCT04474457</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age</brief_title>
  <official_title>An ObservationaI Study to Evaluate the Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age Who Are Receiving Favipiravir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hacettepe University, School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Prof. Dr. Cemil Tascıoglu City Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istanbul Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tepecik Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankara Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ege University Hospital (Application and Research Center)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Derince Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kayseri City Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ministry of Health, Turkey</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an observational study (Non-interventional study) to evaluate the safety and&#xD;
      efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and&#xD;
      initiated treatment with favipiravir before enrollment to the study. Patients who have&#xD;
      already had a routine favipiravir treatment decision or alternatively favipiravir treatment&#xD;
      started at the time of enrollment, will be included in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic&#xD;
      infection, a mild upper respiratory tract infection, respiratory failure, and even severe&#xD;
      viral pneumonia with death. Although the mortality rate is not yet clear, the reported&#xD;
      case-fatality risk was 11-14% during the initial studies which included patients with severe&#xD;
      disease. The overall case fatality rate was reported as approximately 2%. In addition, most&#xD;
      cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator&#xD;
      support. The alarming levels of spread and severity of COVID-19 caused a global emergency and&#xD;
      this outbreak has been characterized as a pandemic by the World Health Organization (WHO).&#xD;
&#xD;
      Studies have suggested that investigational product favipiravir can improve the recovery of&#xD;
      patients with mild disease and reduce the treatment duration from less than 11 days.&#xD;
&#xD;
      The main purpose of this study is to obtain efficacy and safety data for favipiravir use in&#xD;
      the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with&#xD;
      &quot;Favipiravir&quot; before enrollment to this observational study. This study is designed as an&#xD;
      observational drug study which will evaluate the safety and efficacy of favipiravir in&#xD;
      patients and diagnosed with COVID-19 and older than 15 years of age.&#xD;
&#xD;
      This study is designed as an observational drug study to evaluate the safety and efficacy of&#xD;
      favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a&#xD;
      favipiravir treatment decision. Patients who have already had a routine favipiravir treatment&#xD;
      decision or favipiravir treatment started will be included in this study.&#xD;
&#xD;
      A total of 1000 female and male patients aged 15 years or older will be included in the&#xD;
      study. The planned observation duration for each patient is 7 days.&#xD;
&#xD;
      This study will be conducted in 14 sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to recovery (discharge)</measure>
    <time_frame>7 days</time_frame>
    <description>The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decrease in viral load</measure>
    <time_frame>7 days</time_frame>
    <description>The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment</measure>
    <time_frame>7 days</time_frame>
    <description>Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of occurrence of lymphopenia from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of occurrence of thrombocytopenia from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alanine aminotransferase (ALT) levels from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of ALT levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in aspartate aminotransferase (AST) levels from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of AST levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in C-reactive protein (CRP) levels from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of CRP levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in level of D-dimer levels from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of D-dimer levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in prothrombin time (PT) values from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in partial thromboplastin time (PTT) values from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of respiratory rate levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pulse oximetry from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of pulse oximetry levels from baseline until the end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fever from baseline</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical evaluation of changes in fever from baseline until the end of study.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID-19/Favipiravir</arm_group_label>
    <description>Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with &quot;Favipiravir&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with &quot;Favipiravir&quot;.</description>
    <arm_group_label>COVID-19/Favipiravir</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1000 patients aged 15 years or older and diagnosed with COVID-19 who meet&#xD;
        inclusion/exclusion criteria of the study and have decision of treatment with favipiravir .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or&#xD;
             older at the time of enrollment&#xD;
&#xD;
          -  Patients who have understood all study procedures that will be applied under the study&#xD;
             protocol&#xD;
&#xD;
          -  Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and&#xD;
             have a treatment decision with favipiravir&#xD;
&#xD;
          -  Patients who will accept oropharyngeal sample and venous blood sample collection&#xD;
             periodically within the scope of the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or females who are breast feeding&#xD;
&#xD;
          -  Patients under the age of 15&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University, School of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Prof. Ates KARA, MD</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </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>
  <!-- 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/NCT04474457
org study id: COVID-19-PMS-FAV
nct id: NCT04474457
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is an observational study (Non-interventional study) to evaluate the safety and
      efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and
      initiated treatment with favipiravir before enrollment to the study. Patients who have
      already had a routine favipiravir treatment decision or alternatively favipiravir treatment
      started at the time of enrollment, will be included in this study.
The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic
      infection, a mild upper respiratory tract infection, respiratory failure, and even severe
      viral pneumonia with death. Although the mortality rate is not yet clear, the reported
      case-fatality risk was 11-14% during the initial studies which included patients with severe
      disease. The overall case fatality rate was reported as approximately 2%. In addition, most
      cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator
      support. The alarming levels of spread and severity of COVID-19 caused a global emergency and
      this outbreak has been characterized as a pandemic by the World Health Organization (WHO).

      Studies have suggested that investigational product favipiravir can improve the recovery of
      patients with mild disease and reduce the treatment duration from less than 11 days.

      The main purpose of this study is to obtain efficacy and safety data for favipiravir use in
      the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with
      "Favipiravir" before enrollment to this observational study. This study is designed as an
      observational drug study which will evaluate the safety and efficacy of favipiravir in
      patients and diagnosed with COVID-19 and older than 15 years of age.

      This study is designed as an observational drug study to evaluate the safety and efficacy of
      favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a
      favipiravir treatment decision. Patients who have already had a routine favipiravir treatment
      decision or favipiravir treatment started will be included in this study.

      A total of 1000 female and male patients aged 15 years or older will be included in the
      study. The planned observation duration for each patient is 7 days.

      This study will be conducted in 14 sites.
observational model: Cohort
time perspective: Prospective
measure: Time to recovery (discharge)
time frame: 7 days
description: The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
measure: Decrease in viral load
time frame: 7 days
description: The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
measure: Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
time frame: 7 days
description: Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.
measure: Frequency of occurrence of lymphopenia from baseline
time frame: 7 days
description: Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
measure: Frequency of occurrence of thrombocytopenia from baseline
time frame: 7 days
description: Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
measure: Changes in alanine aminotransferase (ALT) levels from baseline
time frame: 7 days
description: Clinical evaluation of ALT levels from baseline until the end of study.
measure: Changes in aspartate aminotransferase (AST) levels from baseline
time frame: 7 days
description: Clinical evaluation of AST levels from baseline until the end of study.
measure: Changes in C-reactive protein (CRP) levels from baseline
time frame: 7 days
description: Clinical evaluation of CRP levels from baseline until the end of study.
measure: Changes in level of D-dimer levels from baseline
time frame: 7 days
description: Clinical evaluation of D-dimer levels from baseline until the end of study.
measure: Changes in prothrombin time (PT) values from baseline
time frame: 7 days
description: Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.
measure: Changes in partial thromboplastin time (PTT) values from baseline
time frame: 7 days
description: Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.
measure: Changes in blood pressure from baseline
time frame: 7 days
description: Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.
measure: Changes in respiratory rate from baseline
time frame: 7 days
description: Clinical evaluation of respiratory rate levels from baseline until the end of study.
measure: Changes in pulse oximetry from baseline
time frame: 7 days
description: Clinical evaluation of pulse oximetry levels from baseline until the end of study.
measure: Changes in fever from baseline
time frame: 7 days
description: Clinical evaluation of changes in fever from baseline until the end of study.
arm group label: COVID-19/Favipiravir
description: Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".
intervention type: Drug
intervention name: Favipiravir
description: Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".
arm group label: COVID-19/Favipiravir
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Prof. Ates KARA, MD
investigator title: Prof.
mesh term: COVID-19
mesh term: Favipiravir