COVID-19 Clinical Trial
Official title:
Open Multicenter Controlled Clinical Trial to Evaluate Safety and Efficacy of Aerosolized MIR 19 ® Inhalation in Adult Outpatients With Mild COVID-19.
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.
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: 1. 5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs. 2. 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. ;
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