Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19
Condition: Sars-CoV2; COVID-19
MeSH terms: COVID-19
Intervention: Favipiravir; Placebo; Standard of care treatment
Intervention description: 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).; Placebo to match favipiravir administered orally through day 10.; Standard of care treatment for COVID-19 infection
Intervention MeSH terms: Favipiravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.