Efficacy and Safety of Ergoferon for COVID-19 Prevention During Vaccination Against SARS-CoV-2

Phase 3 Completed 1057 enrolled Materia Medica Holding

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial. The objective of this study is to evaluate the efficacy and safety of Ergoferon as a non-specific preventive medicine for COVID-19 in individuals vaccinated against a new coronavirus infection (SARS-CoV-2)

Timeline

Start: 2021-10-06
Primary completion: 2022-04-14
Completion: 2022-04-14

Outcome

Met primary endpoint

paper The primary endpoint - the number of laboratory-confirmed cases of SARS-CoV-2 infections was 3 times less compared to placebo - 7 (1.43%) vs 22 (4.57%), respectively (p=0.0046; PMID 37167165 ↗

Publications

Avdeeva MG, Belousova ON, Orlova EA, Khamitov RF, Shvarts YG, Kravchenko IE. [Non-specific prevention of COVID-19 during vaccination against a new coronavirus infection: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial]. Ter Arkh. 2022 Dec 26;94(11):1268-1277. doi: 10.26442/00403660.2022.11.201980. Russian.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ergoferon	Protein / enzyme biologic	—	Oral

Indications

No indication recorded.