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

NCT04358549 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FAVI-COV-US201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to Viral Clearance

  To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling

  Day 29

Secondary Outcomes (5)

• Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale

  on Day 15

• Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge

  through Day 29

• Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax

  through Day 14

• Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin

  through Day 14

• Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)

  through Day 14

Study Arms (2)

Favipiravir Treatment Arm

EXPERIMENTAL

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 Arm

OTHER

Standard of Care for 14 days

Other: Standard of Care

Interventions

Favipiravir DRUG

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

Favipiravir Treatment Arm

Standard of Care OTHER

Standard of Care for individual study site as determined by each hospital's protocol

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Adults (18 to 80 years old):
• within 72 hours of their hospitalization for infection with Severe Acute Respiratory Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,
• 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,
• within 10 days of onset of any COVID-19 symptoms.

You may not qualify if:

• Subject has a concomitant bacterial respiratory infection unless cleared by the Sponsor
• Subject has a history of abnormalities of uric acid metabolism unless cleared by the Sponsor.
• Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug targeting a viral RNA polymerase
• 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.
• 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).
• Has previously received favipiravir within the past 30 days
• Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.
• Has liver impairment greater than Child-Pugh A.
• Has a history of alcohol or drug abuse in the previous 6 months.
• Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
• Has taken another investigational drug within the past 30 days.
• Is on another antiviral or is participating in another clinical trial for the treatment of COVID-19
• Subject is on a ventilator at the time of study entry
• Is deemed by the Investigator to be ineligible for any reason.

Sponsors & Collaborators

• Fujifilm Pharmaceuticals U.S.A., Inc.: lead

Study Sites (8)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Health Care

Worcester, Massachusetts, 01605, United States

Location

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Finberg RW, Ashraf M, Julg B, Ayoade F, Marathe JG, Issa NC, Wang JP, Jaijakul S, Baden LR, Epstein C. US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19. Open Forum Infect Dis. 2021 Dec 7;8(12):ofab563. doi: 10.1093/ofid/ofab563. eCollection 2021 Dec.

  PMID: 34888401 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Clinical Research Manager
• Organization: FUJIFILM Pharmaceuticals U.S.A., Inc.

fphucontact@fujifilm.com

No phone at site

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: April 17, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: March 29, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)