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Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19

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ClinicalTrials.gov Identifier: NCT04346628
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE July 12, 2020
Actual Primary Completion Date April 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ]
Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ]
Time in days from randomization to a negative result of nasopharyngeal and/or oropharyngeal and/or salivary swab.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Sars-CoV-2 viral load [ Time Frame: Up to 28 days ]
    Viral load (nucleic acid) will be assessed by RT-PCR over time.
  • Count of participants with clinical worsening of COVID-19 disease [ Time Frame: Up to 28 days ]
    Clinical worsening will be determined by clinician assessment.
  • Count of participants with development of SARS-CoV-2 antibodies [ Time Frame: Up to 28 days ]
  • Time until cessation of symptoms [ Time Frame: Up to 28 days ]
  • Count of participant with absence of development of any symptoms [ Time Frame: Up to 28 days ]
    This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment
  • Cmax of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
    Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
  • Cmin of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
    Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Count of participants with clinical worsening of COVID-19 disease [ Time Frame: Up to 28 days ]
    Clinical worsening will be determined by clinician assessment.
  • Sars-CoV-2 viral load [ Time Frame: Up to 28 days ]
    Viral load will be assessed as the TCID50 (Median Tissue Culture Infectious Dose) over time.
  • Count of participants with development of SARS-CoV-2 antibodies [ Time Frame: Up to 28 days ]
  • Time until cessation of symptoms [ Time Frame: Up to 28 days ]
  • Cmax of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
    Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.
  • Cmin of favipiravir [ Time Frame: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration) ]
    Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19
Official Title  ICMJE A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
Brief Summary The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sars-CoV2
  • COVID-19
Intervention  ICMJE
  • Drug: Favipiravir
    Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
  • Drug: Placebo
    Placebo to match favipiravir administered orally through day 10.
  • Other: Standard of care treatment
    Standard of care treatment for COVID-19 infection
Study Arms  ICMJE
  • Experimental: Favipiravir
    In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.
    Interventions:
    • Drug: Favipiravir
    • Other: Standard of care treatment
  • Active Comparator: Placebo
    In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.
    Interventions:
    • Drug: Placebo
    • Other: Standard of care treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2021)
149
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
120
Actual Study Completion Date  ICMJE April 16, 2021
Actual Primary Completion Date April 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of COVID-19 disease:

    • If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.
    • If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent
  • Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
  • Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
  • Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
  • Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
  • Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
  • Females must have a negative pregnancy test at screening
  • Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

Exclusion Criteria:

  • Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
  • History of abnormal uric acid metabolism.
  • History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
  • Abnormal laboratory test results at screening:
  • Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
  • Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
  • Previously received favipiravir within the past 30 days.
  • Advanced kidney disease
  • Advanced liver disease
  • History of alcohol or drug abuse in the previous two years.
  • Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
  • Taken another investigational drug within the past 30 days.
  • Seemed by the Investigator to be ineligible for any reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04346628
Other Study ID Numbers  ICMJE 56032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No current plan to share individual participant data (IPD).
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yvonne (Bonnie) A Maldonado, MD Stanford University
PRS Account Stanford University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP