COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04828564

Alpay Azap, MD, Prof

azap@medicine.ankara.edu.tr

2021-04-02

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

- 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.

2

The Scientific and Technological Research Council of Turkey

18

100

Turkey

Mild disease at enrollment

1: Mild disease at enrollment

100

Hospitalized patient rates

None

Phase 2/Phase 3

[{"arm_notes": " ", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 1120, "treatment_name": "Ribavirin", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]