Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
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|ClinicalTrials.gov Identifier: NCT04358549|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Favipiravir + Standard of Care Drug: Standard of Care||Phase 2|
This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with 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 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 3 study sites in the US.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|Official Title:||Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir v. Standard of Care in Hospitalized Subjects With COVID-19|
|Actual Study Start Date :||April 17, 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
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 + Standard of Care
Drug: favipiravir + Standard of Care 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
Drug: Standard of Care
Standard of Care
- 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
- Status of clinical recovery as measured by the study-specific 6-point ordinal scale on Day 15 [ Time Frame: through 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.
- Clinical effect of favipiravir + SOC compared to SOC measured by the National Early Warning Score 2 (NEWS2) [ Time Frame: through Day 29 ]The NEWS 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.
- Characterize the pharmacokinetics (PK) of favipiravir in plasma: Cmax) [ Time Frame: through Day 14 ]Measurement of maximum plasma concentration
- Characterized the pharmacokinetics (PK) of favipiravir in plasma: Cmin [ Time Frame: through Day 14 ]Measurement of minimum plasma concentration
- Characterized the pharmacokinetics (PK) of favipiravir in plasma: AUC [ Time Frame: through Day 14 ]Measurement of the area under the curve of plasma concentration versus time profile
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
|Contact: FPHU Study Coordinatorfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|UMass Memorial Health Care||Recruiting|
|Worcester, Massachusetts, United States, 01605|