Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Favipiravir; Standard of Care
Intervention description: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets; Standard of Care for individual study site as determined by each hospital's protocol
Intervention MeSH terms: Favipiravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Adults (18 to 80 years old):

          1. within 72 hours of their hospitalization for infection with Severe Acute Respiratory
             Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,

          2. within 72 hours of the latest Polymerase Chain Reaction (PCR) positive result and
             within 7 days of the 1st PCR positive result for SARS-CoV-2. (The latest PCR could be
             the only PCR result.), AND,

          3. within 10 days of onset of any COVID-19 symptoms.

        Exclusion Criteria:

          1. Subject has a concomitant bacterial respiratory infection unless cleared by the
             Sponsor

          2. Subject has a history of abnormalities of uric acid metabolism unless cleared by the
             Sponsor.

          3. Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug
             targeting a viral RNA polymerase

          4. Subject is using 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). Dexamethasone 6 mg daily
             (PO or IV) for 10 days is permitted.

          5. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV),
             cancer requiring chemotherapy within the preceding 6 months, moderate or severe
             hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular,
             or endocrinologic disease states requiring medication dose adjustments within the last
             30 days).

          6. Has previously received favipiravir within the past 30 days

          7. Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal
             dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.

          8. Has liver impairment greater than Child-Pugh A.

          9. Has a history of alcohol or drug abuse in the previous 6 months.

         10. Has a psychiatric disease that is not well controlled where controlled is defined as:
             stable on a regimen for more than one year.

         11. Has taken another investigational drug within the past 30 days.

         12. Is on another antiviral or is participating in another clinical trial for the
             treatment of COVID-19

         13. Subject is on a ventilator at the time of study entry

         14. Is deemed by the Investigator to be ineligible for any reason.