Status:
UNKNOWN
Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19
Lead Sponsor:
The Scientific and Technological Research Council of Turkey
Collaborating Sponsors:
Ankara City Hospital Bilkent
Istanbul Umraniye Training and Research Hospital
Conditions:
SARS-CoV2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a national, multicenter, open-label, randomized, phase II/III trial that evaluates the efficacy and safety of favipiravir and ribavirin in the treatment of patients with confirmed COVID-19 obs...
Detailed Description
The clinical picture of COVID-19 disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia w...
Eligibility Criteria
Inclusion
- Female or male patients aged 18 years and older infected with the SARS-CoV-2 virus.
- Patients that have COVID-19 symptoms within 72 hours and have a positive PCR test result.
- Patients in a stable clinical condition and referred as outpatient for COVID-19 infection.
- Patients who sign the informed consent before the any study procedures.
Exclusion
- Patients who have required hospitalization.
- Patients who have required intensive care.
- Patients who do not sign the informed consent.
- Any condition that in the investigator's judgement might interfere with study procedures or the ability of the patient to adhere to and complete the study.
- Patients who have been participating in any other clinical trial.
- Severe liver failure (Child Pugh score ≥ C, transaminase\>5 times the upper limit of normal (ULN).
- Severe renal failure (GFR ≤30 mL/min/1.73 m2) or continuous dialysis (hemodialysis, peritoneal dialysis) or continuous renal replacement therapy.
- Severe cardiac disease.
- History of hypersensitivity to either ribavirin/favipiravir.
- Pregnant or breast-feeding.
- Patients who cannot use appropriate contraceptive method during and after the study.
- Patients who are treated with any other treatment agent for COVID-19 in the last 90 days.
- Patients who had COVID-19 vaccination.
- Patients who had ribavirin/favipiravir for any reason in the past 72 hours.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04828564
Start Date
April 1 2021
End Date
December 31 2021
Last Update
April 2 2021
Active Locations (4)
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1
Ankara University, School of Medicine
Ankara, Cebeci, Turkey (Türkiye), 06590
2
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
3
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
4
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye), 34764