Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19

Upon signing the informed consent form and screening, 240 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either molnupiravir capsules, 800 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC

Inclusion criteria

• Availability of PIS Informed Consent Form signed and dated by a patient.
• Male and female subjects aged 18 to 80 inclusive as of the time of signing the PIS Informed Consent Form.
• Confirmed COVID-19 at screening stage: positive for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay.

SARS-CoV-2 test results obtained up to 5 days prior to randomization may be taken into account upon availability of supporting documentation.

• Mild or moderate SARS-CoV-2 induced infection.
• At least one of the following COVID-19 symptoms as of the time of screening and randomization: nasal congestion or rhinitis; sore throat; dyspnoea or respiratory distress on exertion; cough; tiredness; pain in muscles or throughout the body; headache; chills; fever (body temperature >38 ⁰С); nausea; vomiting; diarrhea; anosmia; ageusia.
• Disease onset (first symptom) within not more than 5 days prior to randomization .
• The patient agrees and is able to take oral drug products.
• Patient's consent to use reliable contraception methods during the entire study and for 3 weeks after the end of the study. Reliable contraception methods are: sexual abstinence, the use of a condom combined with a spermicidal agent.

Female subjects incapable of bearing children (history: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as male subjects with infertility or a history of vasectomy may participate in the study.

Exclusion criteria

• Hypersensitivity to the study drug components.
• Favipiravir intake within 7 days prior to screening.
• Necessity to use drugs included the prohibited therapy list.
• Hospitalization necessity or expected hospitalization due to COVID-19 within 48 hrs after randomization.
• Severe and extremely severe disease signs as of the time of screening.
• Vaccination within less than 4 weeks prior to screening.
• Possible or confirmed moderate COVID-19 within 6 months prior to screening.
• Possible or confirmed history of severe or very severe COVID-19.
• Patients with chronic kidney disease on dialysis or with GFR < 30 mL/min as of the time of screening.
• History of HIV, syphilis, HBV and/or HCV.
• Blood components transfusion within 7 days prior to screening.
• Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening).
• Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening.
• Any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study.
• Unwillingness or inability of a patient to comply with the Protocol procedures (in the opinion of the investigator).
• Pregnant or lactating women, or women planning a pregnancy.
• Participation in another clinical study within 3 months prior to enrollment in the present study.
• Other conditions investigator considers as preventing the patient from inclusion in the study.