An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients without Pneumonia − An open-label randomized controlled study −
Study ID: TCTR20200514001
Current status: Pending (Not yet recruiting)
Last Updated: May 13, 2020
Tracking Information
Date of Registration in Primary Registry: May 12, 2020
Date of First Enrollment: June 01, 2020 (Anticipated)
Target Sample Size: 96
Last Updated Date: May 13, 2020
Primary Outcome(s):
  • Outcome name: Time to improvement in body temperature and SpO2 without chest imaging findings, and negative SARS-C
       Metric/method of measurement: Vital Sign, SpO2, and chest imaging
       Time point: Day 1 to Day 28
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: Changes in patient status on a 7-point scale
       Metric/method of measurement: NEWS Classification
       Time point: Day 1 to Day 28
       Safety Issue?: No


  • Outcome name: Changes in the level of SARS-CoV-2 viral genome
       Metric/method of measurement: RT-PCR
       Time point: Day 1 (before the start of study drug administration), 4, 7, 10, 13, 16, 19, 22, 25, 28
       Safety Issue?: No


  • Outcome name: Time to disappearance of SARS-CoV-2
       Metric/method of measurement: The time from the initiation of study drug administration until SARS-CoV-2 becomes negative
       Time point: Day 1 (before the start of study drug administration), 4, 7, 10, 13, 16, 19, 22, 25, 28
       Safety Issue?: No


  • Outcome name: Duration of pyrexia and SpO2 findings
       Metric/method of measurement: Body temperature and SpO2
       Time point: Day 1 (before the start of the study treatment) to Day 28
       Safety Issue?: No


  • Descriptive Information
    Public Title: An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients without Pneumonia − An open-label randomized controlled study −
    Scientific Title: An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients without Pneumonia − An open-label randomized controlled study −
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Randomized controlled trial
    Control: Placebo
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Open Label (Masked Roles: )
    Primary Purpose: Treatment
    Study Phase: Phase 2/Phase 3
    Health Condition(s) or Problem(s) Studied: COVID-19
    Study Arms:
  • Arm: 1
  • Intervention Name: Favipiravir
    Type: Active Comparator
    Classification: Drug
    Descriptions: Supportive care + favipiravir 1800 mg × 2 times/day × 1 day + 800 mg × 2 times/day × 4 (minimum) -13 days (Maximum)
  • Arm: 2
  • Intervention Name: Supportive care
    Type: No Intervention
    Classification: No treatment
    Descriptions: Supportive care (symptomatic therapy) × 14 days (Maximum)
    Recruitment Information
    Recruitment Status: Pending (Not yet recruiting)
    Estimated Enrollment: 96
    Study Start Date (First enrollment): June 01, 2020
    Primary Completion Date: March 31, 2021
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 74 Years
    (1) Age: 18 to 74 years (at the time of informed consent)
    (2) Gender: Male or female
    (3) Patients who meet all of the following criteria 1), 2), and 3) at the time of enrollment
    1) Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT-PCR test
    2) Patients without new lung lesions on chest images
    3) Patients with a fever of 37.5°C or more
    (4) For premenopausal female patients, patients who have been confirmed to be negative on a urine pregnancy test before administration of the study drug
    (5) Patients who understand the contents of this study and are able to provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents
    Exclusion Criteria
    1 Fever 37 5 C more than 10 days after the onset of fever
    2 Patients with SpO2 less than 95 without oxygen therapy
    3 Patients who show increased procalcitonin levels before the start of study drug administration and are suspected to have concurrent bacterial infection
    4 Patients with suspected concomitant fungal infections prior to initiation of study drug e g 1 3 glucan 30 pg ml or higher
    5 Patients who show for example abnormal NT pro BNP levels 100 pg mL or higher etc and or are suspected to have concurrent congestive heart failure
    6 Patients with severe hepatic impairment equivalent to Grade C on Child Pugh classification
    7 Patients with renal impairment requiring dialysis
    8 Patients with disturbed consciousness such as disturbed orientation
    9 Pregnant or possibly pregnant patients
    10 Female patients who are unable to consent to contraceptive use of oral contraceptives mechanical contraceptives such as intrauterine devices or barrier devices pessaries condoms or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration
    11 Male patients whose partner cannot agree to use the contraception method described in 10 above
    12 Patients who cannot consent to the use of condoms from the start of favipiravir administration to 7 days after the end of favipiravir administration
    13 Patients with hereditary xanthinuria
    14 Patients who have previously ever been diagnosed with hypouricemia 1 mg dL or xanthine urinary calculi
    15 Patients with a history of gout or on treatment for gout or hyperuricemia
    16 Patients receiving immunosuppressants
    17 Patients who have received interferon alpha or drugs with reported antiviral activity against SARS CoV 2 hydroxychloroquine sulfate chloroquine phosphate lopinavir ritonavir combination ciclesonide nafamostat mesylate camostat mesylate remdesivir etc within 9 days after fever 37 5 C or more
    18 Patients in whom this episode of infection is a recurrence or reinfection of SARS CoV 2 infection
    19 Patients who have previously received favipiravir T 705a
    20 Other patients judged ineligible by the investigator sub investigator or assigned physician

    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Rujipas Sirijatuphat
    Degree: MD
    Phone: 0840665961
    Email: rujipas.sir@mahidol.ac.th
    Postal Address: 2 Wanglang Road Bangkoknoi
    State/Province: Bangkok        Postal Code: 10700
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20200514001
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of Medicine, Siriraj Hospital
    Study Primary Sponsor: Faculty of Medicine, Siriraj Hospital
    Study Secondary Sponsor: 1.) Health System Research Institute (HSRI)
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Rujipas Sirijatuphat
    Degree: MD
    Phone: 0840665961
    Email: rujipas.sir@mahidol.ac.th
    Postal Address: 2 Wanglang Road Bangkoknoi
    State/Province: Bangkok        Postal Code: 10700
    Country: Thailand
    Track changes

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