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Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346628
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The objective of this study is to evaluate the efficacy of oral favipiravir compared with SOC in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.

Condition or disease Intervention/treatment Phase
COVID Drug: Favipiravir Other: Standard of care treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to received either favipiravir + Standard of Care (SOC) or SOC alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open Label Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild COVID-19
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Favipiravir
Participants will receive favipiravir for 10 days plus standard of care treatment for COVID-19 infection.
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).

Other: Standard of care treatment
Standard of care treatment for COVID-19 infection

Active Comparator: Standard of Care
Participants will receive standard of care treatment for COVID-19 infection.
Other: Standard of care treatment
Standard of care treatment for COVID-19 infection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Count of participants with clinical worsening of COVID-19 disease [ Time Frame: Up to 28 days ]
    Clinical worsening will be determined by clinician assessment.

  2. 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.

  3. Count of participants with development of SARS-CoV-2 antibodies [ Time Frame: Up to 28 days ]
  4. Time until cessation of symptoms [ Time Frame: Up to 28 days ]
  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with laboratory confirmation of infection with SARS-CoV-2 and who are PCR positive (within five days or fewer prior to enrollment)
  • Asymptomatic or mild respiratory disease, defined as a respiratory rate no more than 20 breaths per minute and a normal oxygen saturation
  • No more than four of the following of mild severity, and no more than two of moderate severity:

    • Cough
    • Sore throat
    • Headache
    • Nasal congestion
    • Body aches and pains
    • Fatigue
  • Temperature less than 101 F

Exclusion Criteria:

  • Concomitant bacterial respiratory infection
  • History of abnormalities of uric acid metabolism.
  • History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
  • Use of adrenocorticosteroids (except topical preparation or inhaled steroids) or immunosuppressive drugs (e.g., immunosuppressants, anticancer drugs)
  • Serious chronic disease
  • Previously received favipiravir.
  • Renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
  • Liver impairment greater than Child Pugh 1.
  • History of alcohol or drug abuse in the previous two years
  • Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year)
  • Patient has taken another investigational drug within the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346628


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Contact: Study Team    650-721-5805    altamira@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Yvonne (Bonnie) A Maldonado, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04346628    
Other Study ID Numbers: 56032
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share individual participant data (IPD).

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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