Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 observed within 72 hours. Approximately 100 patients will be randomized in 1:1 ratio and divided into two groups.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Scientific and Technological Research Council of Turkey
• Collaborators: Ankara City Hospital Bilkent; Istanbul Umraniye Training and Research Hospital; Koç University; Monitor CRO
• Treatments: Favipiravir; Ribavirin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.