This is Phase 2b-3 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® via 7 days treatment in a dose of 5.55 mg/day of participants with symptomatic mild COVID-19 who did not require hospitalisation.~The MIR 19® is a complex of siRNA, targeting Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase (RdRp) and peptide dendrimer (KK-46).~This study involved 2 cohorts who received:~5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs.~Standard therapy which included symptomatic treatment as well as etiotropic drugs except MIR 19 ®.~All subjects will undergo scheduled safety and efficacy assessments as outpatients to the end of the follow-up period.
The aim of this study is to evaluate the effectiveness and safety of MIR 19 ® in preventing development of moderate and/or severe course of the disease in mild COVID-19 outpatients.~Primary endpoint:~The proportion of patients with the development of moderate or severe COVID-19 disease (in accordance with the criteria specified in the Interim Guidelines Prevention, diagnosis and treatment of new coronavirus infection (COVID-19) by the Ministry of Health of the Russian Federation, version 14 of 27.12.2021 or current at the time of the study) by the 28th day of observation.