NCT05722691

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Promomed, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Double-Stranded RNA sodium salt	Once intramuscular injection 5 mg (1 vial)
DRUG	Placebo	Once intramuscular injection (1 vial)

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-11-22
• Completion: 2023-01-17
• First posted: 2023-02-10
• Last updated: 2023-02-16

Locations

10 sites across 1 country: Russia