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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358549
• Other study ID #: FAVI-COV-US201
• Status: Completed
• Phase: Phase 2
• Start date: April 17, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2022
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Atlantic Health System / Morristown Medical Center	Morristown	New Jersey
United States	HonorHealth	Scottsdale	Arizona
United States	UMass Memorial Health Care	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Pharmaceuticals U.S.A., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale	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.	on Day 15
Secondary	Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge	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.	through Day 29
Secondary	Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax	Measurement of maximum plasma concentration	through Day 14
Secondary	Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin	Measurement of minimum plasma concentration	through Day 14
Secondary	Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)	Measurement of the area under the curve of plasma concentration versus time profile	through Day 14