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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Favipiravir
Standard of Care
Sponsored by
Fujifilm Pharmaceuticals U.S.A., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HonorHealth
  • University of Miami Miller School of Medicine
  • Boston Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • UMass Memorial Health Care
  • Atlantic Health System / Morristown Medical Center
  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Favipiravir Treatment Arm

Standard of Care Arm

Arm Description

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

Standard of Care for 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax
Measurement of maximum plasma concentration
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin
Measurement of minimum plasma concentration
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

Full Information

First Posted
April 16, 2020
Last Updated
March 25, 2022
Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04358549
Brief Title
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Favipiravir Treatment Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care Arm
Arm Type
Other
Arm Description
Standard of Care for 14 days
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care for individual study site as determined by each hospital's protocol
Primary Outcome Measure Information:
Title
Time to Viral Clearance
Description
To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale
Description
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.
Time Frame
on Day 15
Title
Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge
Description
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.
Time Frame
through Day 29
Title
Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax
Description
Measurement of maximum plasma concentration
Time Frame
through Day 14
Title
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin
Description
Measurement of minimum plasma concentration
Time Frame
through Day 14
Title
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)
Description
Measurement of the area under the curve of plasma concentration versus time profile
Time Frame
through Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Atlantic Health System / Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34888401
Citation
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.
Results Reference
derived

Learn more about this trial

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

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