Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis

Upon signing the informed consent form and screening, 800 eligible subjects resides with a person with confirmed COVID-19 were randomized at a 1:1 ratio to receive either RADAMIN®VIRO once intramuscularly 5 mg (1 vial) or 1 vial of placebo once intramuscularly

Inclusion criteria

• Male and female subjects aged 18 to 80 inclusive (subjects) as of the time of signing the Subject Information Sheet (SIS) Informed Consent Form.
• A subject resides with a person with confirmed COVID-19 who meets both of the following criteria:

• The first positive result for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay, obtained up to 72 hours prior to randomisation of a subject participating in the study.
• At least one of the symptoms typical of COVID-19 is observed, with symptoms onset no more than 5 days prior to the randomisation of the subject participating in the study.
• Negative result for antigen of SARS-CoV-2 with immunochromatographic assay.
• No symptoms typical of COVID-19 observed.
• A subject is expected to continue to reside with a person with confirmed COVID-19 during the entire clinical study period; hospitalisation of a person with officially confirmed COVID-19 is not needed at the time of study subject's randomisation.
• Subject'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.
• Availability of SIS Informed Consent Form signed and dated by a patient.
• Availability of Informed Consent Form for collection of information on COVID-19 signed and dated by a person with confirmed COVID-19.

Exclusion criteria

• Hypersensitivity to the study drug components, procaine.
• Contraindications to intramuscular injections.
• Contact with 2 or more persons with confirmed COVID-19 within a month prior to screening or residing with 2 or more people with officially confirmed COVID-19 at the time of screening.
• Joint residence with more than 10 people.
• Laboratory-confirmed case of COVID-19 within 6 months prior to randomisation.
• Vaccination against COVID-19 within less than 4 weeks prior to screening.
• Use or necessity to use unauthorised pharmaceuticals at the time of screening.
• Use of immunostimulatory, immunomodulatory, or immunosuppressive medications within 3 months prior to screening.
• Subjects undergoing renal replacement therapy or with a history of severe renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, within 6 months prior to screening).
• Primary biliary cirrhosis class C according to the Child - Pugh classification or a history of chronic or active hepatitis B or C.
• Positive test result for HIV, syphilis, hepatitis B and/or C at the time of screening.
• Chronic cardiac failure, Functional Class 3 III-IV according to the New York Heart Association (NYHA) Functional Classification.
• A history of malignant tumours, except for subjects with disease being not observed within the last 5 years, subjects with completely cured basal cell skin cancer, or completely cured carcinoma in situ.
• 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 subject due to his/her participation in the study.
• Unwillingness or inability of a subject 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 enrolment in the present study.
• Other conditions that prevent the subject from inclusion in the study.