Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.

Inclusion criteria

• Signing and dating of the Informed Consent Form of the Patient Information Leaflet (PIL) by patients.
• Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
• No difficulty with oral medication (e.g. swallowing disorder).
• Patient diagnosed with "Coronavirus infection caused by SARS-CoV-2 (confirmed)1, moderate severity form*" established in accordance with the Interim Guidelines of the Russian Ministry of Health for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (revision 6 of 28.04.2020).

*Moderate severity form: fever above 38 °C, BR above 22/min, dyspnea during exercise, pneumonia (confirmed by lung CT), SpO2 < 95%, C reactive protein (CRP) serum level above 10 mg/l.

• Patient should be hospitalized no more than 48 hours before the start of the study therapy.
• Positive PCR result for presence of SARS-CoV-2 RNA at screening phase (results obtained within 7 days prior to screening are appropriate).
• Patient's consent to use reliable contraceptive methods throughout the study and within 1 month for women and 3 months for men after its completion. Persons eligible for participation in the study: - Women who have a negative pregnancy test and use the following contraceptives: barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or double barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vaulted cap) plus spermicide (foam/gel/film/cream/suppository)). Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause more than 1 year) or men with preserved reproductive function who use barrier contraceptives, as well as men with infertility or vasectomy in the past medical history.

Exclusion criteria

• Hypersensitivity to favipiravir and/or other components of the study drug.
• Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
• The need to use drugs from the list of prohibited therapy.
• Need for treatment in the intensive care unit.
• Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
• Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 45 ml/min) at the time of screening.
• Positive testing for HIV, syphilis, hepatitis B and/or C.
• Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
• Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• Malignancies in the past medical history.
• Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
• Schizophrenia, schizoaffective disorder, bipolar disorder, or other history of mental pathology or suspicion of their presence at the time of screening.
• Severe, decompensated or unstable somatic diseases (any disease or condition that threaten the patient's life or impair the patient's prognosis, and also make it impossible for him/her to participate in the clinical study).
• Any history data that the investigating physician believes could lead to complication in the interpretation of the study results or create an additional risk to the patient as a result of his/her participation in the study.
• Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
• Pregnant or nursing women or women planning pregnancy.
• Participation in another clinical study for 3 months prior to inclusion in the study.
• Other conditions that, according to the physician investigator, prevent the patient from being included in the study.