To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
Standard of Care for individual study site as determined by each hospital's protocol
HonorHealth
Scottsdale, Arizona, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
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
Time frame: Day 29
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 frame: on Day 15
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.
Time frame: through Day 29
Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax
Measurement of maximum plasma concentration
Time frame: through Day 14
Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin
Measurement of minimum plasma concentration
Time frame: through Day 14
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
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Massachusetts General Hospital
Boston, Massachusetts, United States
UMass Memorial Health Care
Worcester, Massachusetts, United States
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States
Houston Methodist Hospital
Houston, Texas, United States
Time frame: through Day 14