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

Study Overview
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Brief Summary
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This is Double-Blind, Placebo-Controlled Multicentre Clinical Phase III Study conducted in 10 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug Drug RADAMIN®VIRO, Lyophilisate for Preparation of Solution for Intramuscular and Subcutaneous Administration for COVID-19 Postexposure Prophylaxis

Detailed Description
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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

Official Title
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Double-Blind, Placebo-Controlled Multicentre Clinical Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Double-Stranded RNA sodium salt
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-stranded RNA sodium salt<br>Arm 1 (n=400) received the study drug RADAMIN®VIRO once intramuscularly, 5 mg (1 vial). | Drug: Double-Stranded RNA sodium salt<br>* Once intramuscular injection 5 mg (1 vial)<br>* Other names: RADAMIN®VIRO;|
| Placebo Comparator: Placebo<br>Arm 2 (n = 400) received 1 vial of placebo once intramuscularly | Drug: Placebo<br>* Once intramuscular injection (1 vial)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19 | The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19 | From baseline to Visit 3 (days 10-11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19 | The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19 | From baseline to Visit 2 (days 3-4), 4 (days 21 ± 1), 5 (days 28 ± 1) | 
| Сonfirmed COVID-19 and absence of symptoms typical for COVID-19 | The number of subjects with confirmed COVID-19 and absence of symptoms typical for COVID-19 | From baseline to Visit 2 (days 3-4), 3 (days 10-11) | 
| Сonfirmed COVID-19 and absence of symptoms typical for COVID-19 | The number of subjects with confirmed COVID-19 and absence or presence of symptoms typical of COVID-19 | From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1) | 
| Time to COVID-19 infection | Days to COVID-19 infection | From baseline to Visit 5 (study completion, day 28±1) | 
| Symptoms typical of COVID-19 | The severity of symptoms typical of COVID-19 | From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1) | 
| Duration of symptoms typical of COVID-19 | Duration of symptoms (days) typical of COVID-19 | From baseline to Visit 5 (study completion, day 28±1) | 
| COVID-19 severity evaluation | COVID-19 severity evaluation | From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1) | 
| Hospitalisation due to COVID-19 | The number of subjects who needed hospitalisation due to COVID-19 | From baseline to Visit 5 (study completion, day 28±1) | 
| Total adverse events (AEs) stratified by severity and incidence | Number of AEs stratified by severity and incidence | From baseline to Visit 5 (study completion, day 28±1) | 
| Incidence of serious adverse events (SAEs), including those due to the use of the study drug/placebo. | Number of SAEs including those due to the use of the study drug/placebo. | From baseline to Visit 5 (study completion, day 28±1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, RADAMIN®VIRO, Double-stranded RNA sodium salt