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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
800
Once intramuscular injection 5 mg (1 vial)
Once intramuscular injection (1 vial)
Regional Budgetary Healthcare Institution Ivanovo Clinical Hospital
Ivanovo, Russia
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of Ministry of Health of the Russian Federation
Kirov, Russia
State Budgetary Healthcare Institution of Moscow Municipal Clinical Hospital Named after S. I. Spasokukotsky of Moscow Healthcare Department
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
Time frame: From baseline to Visit 3 (days 10-11)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to Visit 5 (study completion, day 28±1)
Symptoms typical of COVID-19
The severity of symptoms typical of COVID-19
Time frame: 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
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Moscow, Russia
Professorskaya Klinika LLC
Perm, Russia
Avrora MedFort LLC
Saint Petersburg, Russia
Eco-Safety R&D Centre LLC
Saint Petersburg, Russia
OrCli Hospital LLC
Saint Petersburg, Russia
Federal State Budgetary Educational Institution of Higher Education N. P. Ogarev Mordovia State University
Saransk, Russia
Federal State Budgetary Educational Institution of Higher Education Smolensk State Medical University of Ministry of Health of the Russian Federation Principal Investigator Kozlov Roman Sergeevich
Smolensk, Russia
Regional State Budgetary Healthcare Institution Clinical Hospital No. 1
Smolensk, Russia
Time frame: From baseline to Visit 5 (study completion, day 28±1)
COVID-19 severity evaluation
COVID-19 severity evaluation
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From baseline to Visit 5 (study completion, day 28±1)