<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/NCT04434248</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-FPR-01</org_study_id>
    <nct_id>NCT04434248</nct_id>
  </id_info>
  <brief_title>An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19</brief_title>
  <official_title>An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chromis LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chemical Diversity Research Institute</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chromis LLC</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>
      The study is Phase II/III and consists of pilot and pivotal stages. The objective of the&#xD;
      pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir,&#xD;
      and to select the optimal dosing regimen to study during the pivotal stage. The objective of&#xD;
      the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the&#xD;
      Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the pilot stage: upon signing the informed consent form and screening, 60 eligible&#xD;
      patients with polymerase chain reaction (PCR) confirmed COVID-19 pneumonia are randomized at&#xD;
      a 1:1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by&#xD;
      600 mg BID on Days 2-14 (1600/600 mg), or Favipiravir 1800 mg BID on Day 1 followed by 800 mg&#xD;
      BID on Days 2-14 (1800/800 mg), or SOC.&#xD;
&#xD;
      At the pivotal stage: additional 270 eligible patients are randomized at a 1:1 ratio to&#xD;
      receive either Favipiravir (the dose regimen depends of the subject's weight) or SOC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 23, 2020</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>This is an adaptive, multicenter, open-label, randomized clinical study of Favipiravir versus standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of viral elimination by Day 10 [pilot stage, dose selection]</measure>
    <time_frame>10 Days</time_frame>
    <description>Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to viral elimination [pivotal stage]</measure>
    <time_frame>28 Days</time_frame>
    <description>Median time to reach undetectable SARS-CoV-2 RNA level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to clinical improvement [pivotal stage]</measure>
    <time_frame>28 Days</time_frame>
    <description>Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of viral elimination</measure>
    <time_frame>Days 3, 5, 7, 9, and 11</time_frame>
    <description>Percent of patients with undetectable SARS-CoV-2 RNA level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to normalization of clinical symptoms</measure>
    <time_frame>28 Days</time_frame>
    <description>Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of oxygen therapy</measure>
    <time_frame>28 Days</time_frame>
    <description>Mean duration of oxygen therapy [days]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the level of lung damage according to CT</measure>
    <time_frame>Days 15, 22, and 29</time_frame>
    <description>Change of lung damage level according to CT comparing to baseline [% of patients]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of transfer to the intensive care unit</measure>
    <time_frame>28 days</time_frame>
    <description>Percent of patients transferred to the intensive care unit [% of patients]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the use of non-invasive lung ventilation</measure>
    <time_frame>28 days</time_frame>
    <description>Percent of patients undergoing non-invasive lung ventilation [% of patients]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the use of mechanical ventilation</measure>
    <time_frame>28 days</time_frame>
    <description>Percent of patients undergoing mechanical ventilation [% of patients]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Percent of patients died within 28-days period [% of patients]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax)</measure>
    <time_frame>Day 1</time_frame>
    <description>Determination of Cmax [ng/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak plasma concentration (Tmax)</measure>
    <time_frame>Day 1</time_frame>
    <description>Determination of Tmax [h]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC0-t)</measure>
    <time_frame>10 days</time_frame>
    <description>Determination of AUC0-t [ng*h/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough plasma concentration (Ctrough)</measure>
    <time_frame>10 days</time_frame>
    <description>Determination of Ctrough [ng/ml]</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Favipiravir, lower dose (pilot stage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1600mg BID on the 1st day followed by 600mg BID for 13 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Favipiravir, higher dose (pilot stage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1800mg BID on the 1st day followed by 800mg BID for 13 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care (pilot stage)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Favipiravir, selected dose (pivotal stage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose will be selected based on pilot study results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care (pivotal stage)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir</intervention_name>
    <description>200 mg coated tablets</description>
    <arm_group_label>Favipiravir, higher dose (pilot stage)</arm_group_label>
    <arm_group_label>Favipiravir, lower dose (pilot stage)</arm_group_label>
    <arm_group_label>Favipiravir, selected dose (pivotal stage)</arm_group_label>
    <other_name>Avifavir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.</description>
    <arm_group_label>Standard of care (pilot stage)</arm_group_label>
    <arm_group_label>Standard of care (pivotal stage)</arm_group_label>
    <other_name>Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Patient Information Sheet and Informed Consent form to participate in the&#xD;
             study.&#xD;
&#xD;
          2. Men and women aged 18 years and older.&#xD;
&#xD;
          3. Patients hospitalized with a diagnosis of COVID-19.&#xD;
&#xD;
          4. The diagnosis of COVID-19 was confirmed by positive reverse transcription polymerase&#xD;
             chain reaction (RT-PCR) test for SARS-CoV-2, performed no earlier than 7 days before&#xD;
             hospitalization or at screening.&#xD;
&#xD;
          5. Moderate severity of COVID-19 with pneumonia with at least 1 of the following&#xD;
             symptoms:&#xD;
&#xD;
               -  Fever above 38 °C;&#xD;
&#xD;
               -  Cough;&#xD;
&#xD;
               -  Shortness of breath during physical exertion;&#xD;
&#xD;
               -  C reactive protein (CRP) of blood serum &gt; 10 mg/l;&#xD;
&#xD;
               -  SpO2 &lt; 95%&#xD;
&#xD;
          6. The capability of oral drug administration.&#xD;
&#xD;
          7. The patients' consent to use adequate contraception methods during the study (condom&#xD;
             with spermicide) and for 3 months following completion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe type of disease, with at least one of the following criteria:&#xD;
&#xD;
               -  Frequency of breath &gt; 35 per minute, which does not decrease after the body&#xD;
                  temperature drops to normal or subfebrile values;&#xD;
&#xD;
               -  Blood oxygen saturation (SpO2) &lt; 90% at rest;&#xD;
&#xD;
               -  Partial pressure of oxygen in arterial blood (PaO2) &lt; 60 mm Hg;&#xD;
&#xD;
               -  Oxygenation index (RaO2/FiO2) ≤ 200 mm Hg;&#xD;
&#xD;
               -  Partial pressure of CO2 in arterial blood (PaCO2) &lt; 60 mm Hg;&#xD;
&#xD;
               -  Septic shock.&#xD;
&#xD;
          2. Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine,&#xD;
             hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening.&#xD;
&#xD;
          3. Severe cardiovascular diseases currently or 6 months prior to randomization,&#xD;
             including: New York Heart Association (NYHA) Class III or IV chronic heart failure,&#xD;
             clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular&#xD;
             fibrillation), unstable angina, myocardial infarction, heart and coronary vessel&#xD;
             surgery, significant valvular heart disease, uncontrolled arterial hypertension with&#xD;
             systolic blood pressure &gt; 180 mm Hg and diastolic blood pressure &gt; 110 mm Hg,&#xD;
             pulmonary embolism or deep vein thrombosis.&#xD;
&#xD;
          4. Severe chronic renal impairment (GFR &lt; 30 ml / min) or continuous renal replacement&#xD;
             therapy, hemodialysis or peritoneal dialysis.&#xD;
&#xD;
          5. A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or&#xD;
             aspartate aminotransferase (AST) &gt; 5 times × upper limit of normal (ULN).&#xD;
&#xD;
          6. Severe diseases of the central nervous system, including seizures in history or&#xD;
             conditions that may lead to their development; stroke or transient ischemic attack&#xD;
             within 12 months prior to screening; head injuries or loss of consciousness within 12&#xD;
             months prior to screening; a brain tumor.&#xD;
&#xD;
          7. Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic,&#xD;
             endocrinological or gastrointestinal disorder which according to the Investigator,&#xD;
             could prevent the patient from participating in the study&#xD;
&#xD;
          8. Malignancies that require chemotherapy within 6 months prior to screening.&#xD;
&#xD;
          9. Known HIV infection&#xD;
&#xD;
         10. Hypersensitivity to any component of the study drug.&#xD;
&#xD;
         11. Participation in other clinical studies or taking other study drugs within 28 days&#xD;
             prior to screening.&#xD;
&#xD;
         12. Pregnant or lactating women or women planning to get pregnant during the clinical&#xD;
             study; women of child-bearing potential (including non-sterilized by surgical means&#xD;
             and during the post-menopause period less than 2 years) who do not use adequate&#xD;
             contraception methods.&#xD;
&#xD;
         13. Inability to read or write, unwillingness to understand and follow procedures of study&#xD;
             protocol, as well as any other concomitant medical or serious mental conditions that&#xD;
             make the patient unfit to participate in the study, limit the legality of obtaining&#xD;
             informed consent or can affect patient's ability to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Pavlikova, MD,PhD,Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moscow State University n.a. M.V. Lomonosov</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nikita Lomakin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Clinical Hospital with Polyclinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Republican Clinical Hospital</name>
      <address>
        <city>Makhachkala</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;K+31&quot; Clinic</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Khaven&quot; Llc</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital with Polyclinic</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Research Institute of Epidemiology</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital n.a. O.M. Filatov</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital named after S.S. Yudin</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital No. 24</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital No. 51</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Moscow State Medical University n.a. I.M. Sechenov</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow State University n.a. M. V. Lomonosov</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical and Surgical Center named after N.I. Pirogov</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital № 33 of the Leninsky region of Nizhny Novgorod</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious clinical hospital No.2 of Nizhny Novgorod</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan State Medical University named after I.P. Pavlov</name>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy named after S.M. Kirova</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University named after V.I. Razumovsky</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical hospital No.1</name>
      <address>
        <city>Smolensk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinic Hospital</name>
      <address>
        <city>Tver</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bashkir State Medical University</name>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yakutsk City Clinical Hospital</name>
      <address>
        <city>Yakutsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Clinical Hospital for War Veterans</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>2019-nCoV</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>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
    <mesh_term>Chloroquine</mesh_term>
    <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/NCT04434248
org study id: COVID-FPR-01
nct id: NCT04434248
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is Phase II/III and consists of pilot and pivotal stages. The objective of the
      pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir,
      and to select the optimal dosing regimen to study during the pivotal stage. The objective of
      the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the
      Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
At the pilot stage: upon signing the informed consent form and screening, 60 eligible
      patients with polymerase chain reaction (PCR) confirmed COVID-19 pneumonia are randomized at
      a 1:1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by
      600 mg BID on Days 2-14 (1600/600 mg), or Favipiravir 1800 mg BID on Day 1 followed by 800 mg
      BID on Days 2-14 (1800/800 mg), or SOC.

      At the pivotal stage: additional 270 eligible patients are randomized at a 1:1 ratio to
      receive either Favipiravir (the dose regimen depends of the subject's weight) or SOC.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This is an adaptive, multicenter, open-label, randomized clinical study of Favipiravir versus standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of viral elimination by Day 10 [pilot stage, dose selection]
time frame: 10 Days
description: Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10
measure: Time to viral elimination [pivotal stage]
time frame: 28 Days
description: Median time to reach undetectable SARS-CoV-2 RNA level
measure: Time to clinical improvement [pivotal stage]
time frame: 28 Days
description: Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital
measure: Rate of viral elimination
time frame: Days 3, 5, 7, 9, and 11
description: Percent of patients with undetectable SARS-CoV-2 RNA level
measure: Time to normalization of clinical symptoms
time frame: 28 Days
description: Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)
measure: Duration of oxygen therapy
time frame: 28 Days
description: Mean duration of oxygen therapy [days]
measure: Change in the level of lung damage according to CT
time frame: Days 15, 22, and 29
description: Change of lung damage level according to CT comparing to baseline [% of patients]
measure: Rate of transfer to the intensive care unit
time frame: 28 days
description: Percent of patients transferred to the intensive care unit [% of patients]
measure: Rate of the use of non-invasive lung ventilation
time frame: 28 days
description: Percent of patients undergoing non-invasive lung ventilation [% of patients]
measure: Rate of the use of mechanical ventilation
time frame: 28 days
description: Percent of patients undergoing mechanical ventilation [% of patients]
measure: Mortality
time frame: 28 days
description: Percent of patients died within 28-days period [% of patients]
measure: Peak plasma concentration (Cmax)
time frame: Day 1
description: Determination of Cmax [ng/ml]
measure: Time to peak plasma concentration (Tmax)
time frame: Day 1
description: Determination of Tmax [h]
measure: Area under the plasma concentration versus time curve (AUC0-t)
time frame: 10 days
description: Determination of AUC0-t [ng*h/ml]
measure: Trough plasma concentration (Ctrough)
time frame: 10 days
description: Determination of Ctrough [ng/ml]
arm group label: Favipiravir, lower dose (pilot stage)
arm group type: Experimental
description: 1600mg BID on the 1st day followed by 600mg BID for 13 days
arm group label: Favipiravir, higher dose (pilot stage)
arm group type: Experimental
description: 1800mg BID on the 1st day followed by 800mg BID for 13 days
arm group label: Standard of care (pilot stage)
arm group type: Active Comparator
description: Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.
arm group label: Favipiravir, selected dose (pivotal stage)
arm group type: Experimental
description: The dose will be selected based on pilot study results.
arm group label: Standard of care (pivotal stage)
arm group type: Active Comparator
description: Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.
intervention type: Drug
intervention name: Favipiravir
description: 200 mg coated tablets
arm group label: Favipiravir, higher dose (pilot stage)
arm group label: Favipiravir, lower dose (pilot stage)
arm group label: Favipiravir, selected dose (pivotal stage)
other name: Avifavir
intervention type: Drug
intervention name: Standard of Care
description: Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
arm group label: Standard of care (pilot stage)
arm group label: Standard of care (pivotal stage)
other name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Pavlikova, MD,PhD,Prof
role: Principal Investigator
affiliation: Moscow State University n.a. M.V. Lomonosov
last name: Nikita Lomakin, MD,PhD
role: Principal Investigator
affiliation: Central Clinical Hospital with Polyclinic
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country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Hydroxychloroquine
mesh term: Chloroquine
mesh term: Favipiravir
sharing ipd: No