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

Inclusion Criteria:

• Diagnosis of COVID-19 disease:
• If symptomatic, presence of mild to moderate symptoms without signs ofrespiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72hours prior to.informed consent.
• If asymptomatic, initial diagnosis obtained no more than 72 hours prior toinformed consent
• Subject agrees to maintain home or other quarantine as recommended by the studyphysician, 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 inclusionand exclusion criteria are met
• Males must be sterile, OR agree not to donate semen AND agree to strictly adhere tocontraceptive measures during the study and for seven days following the last dose ofstudy medication
• Females must be unable to bear children, OR ensure that their male partner isincapable of fathering a child, OR, if of childbearing potential will strictly adhereto contraceptive measures during the study and for seven days following the last doseof study medication
• Females must agree to stop breast-feeding prior to first dose of study drug andthrough 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 studyphysician, 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 bacterialpneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will berandomized 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 viralRNA polymerase.
• Abnormal laboratory test results at screening:
• Use of adrenocorticosteroids (except topical or inhaled preparations or oralpreparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressiveor immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins,interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of studyparticipants following institutional COVID-19 treatment policies or guidelines,including the use of immunomodulatory medications, is permitted. This excludestreatment with agents that have the potential for direct antiviral activity, includingconvalescent plasma and NO, and co-enrollment into other clinical studies thatevaluate investigational agents for COVID-19.
• Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiringchemotherapy within the preceding 6 months, and/or moderate or severe hepaticinsufficiency).
• 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 formore than one year).
• Taken another investigational drug within the past 30 days.
• Seemed by the Investigator to be ineligible for any reason.