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Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19

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ClinicalTrials.gov Identifier: NCT04358549
Recruitment Status : Completed
First Posted : April 24, 2020
Results First Posted : March 29, 2022
Last Update Posted : March 29, 2022
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Favipiravir Other: Standard of Care Phase 2

Detailed Description:

This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (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 bis in die (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19
Actual Study Start Date : April 17, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets

Standard of Care Arm
Standard of Care for 14 days
Other: Standard of Care
Standard of Care for individual study site as determined by each hospital's protocol

Primary Outcome Measures :
  1. Time to Viral Clearance [ Time Frame: Day 29 ]
    To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling

Secondary Outcome Measures :
  1. Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale [ Time Frame: on Day 15 ]
    To determine the clinical benefit of administering favipiravir plus SOC compared to SOC alone, clinical benefit will be measured using a study-specified ordinal scale on Day 15 in adult patients hospitalized with COVID-19.

  2. Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge [ Time Frame: through Day 29 ]
    The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to, or are being monitored in hospital. Six simple physiological parameters form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature. The time to aggregate NEWS2 score of ≤ 2 (sustained for at least 72 hours) or hospital discharge is analyzed.

  3. Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax [ Time Frame: through Day 14 ]
    Measurement of maximum plasma concentration

  4. Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin [ Time Frame: through Day 14 ]
    Measurement of minimum plasma concentration

  5. Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24) [ Time Frame: through Day 14 ]
    Measurement of the area under the curve of plasma concentration versus time profile

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT04358549

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United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
UMass Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, New Jersey
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fujifilm Pharmaceuticals U.S.A., Inc.
  Study Documents (Full-Text)

Documents provided by Fujifilm Pharmaceuticals U.S.A., Inc.:
Study Protocol  [PDF] July 15, 2020
Statistical Analysis Plan  [PDF] December 15, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fujifilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier: NCT04358549    
Other Study ID Numbers: FAVI-COV-US201
First Posted: April 24, 2020    Key Record Dates
Results First Posted: March 29, 2022
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents