Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. ) Adults (18 to 80 years old):
  2. within 72 hours of their hospitalization for infection with SARS-CoV-2, AND,
  3. within 72 hours of the latest 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,
  4. 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.

Study Design

Phase
Phase 2
Study Type
Interventional
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Favipiravir Treatment Arm
Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC
  • Drug: Favipiravir + Standard of Care
    Drug: favipiravir + Standard of Care Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
Other
Standard of Care Arm
Standard of Care for 14 days
  • Drug: Standard of Care
    Standard of Care

More Details

Status
Active, not recruiting
Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.

Study Contact

Detailed Description

This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with COVID-19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone.

The dose regimen will be 1800 mg favipiravir BID plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days.

The study will have 14 days of treatment and 46 days of follow-up.

Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.