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Clinical Trial Summary

This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19® via 14 days of treatment of participants with symptomatic moderate COVID-19. The purpose of this study is to evaluate the efficacy, safety and daily dose of MIR 19 ® for the treatment of the hospitalized patients with infection caused by SARS-CoV-2 (COVID-19) who did not require treatment in the intensive care unit. Based on preclinical data studying antiviral effect of MIR 19® in vitro and in vivo (Khaitov M.R. et all 2021), the investigators hypothesized that SARS-CoV-2 inhibition with MIR 19® could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.


Clinical Trial Description

This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® in male and female volunteers with symptomatic moderate COVID-19 who did not require treatment in the intensive care unit. The MIR 19® is a complex of siRNA, targeting SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) and peptide dendrimer KK-46. This study involved 3 cohorts who received: 1. standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. 2. 3.7 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. 3. 11.1 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. All subjects will undergo scheduled safety and efficacy assessments while in the clinical unit and as outpatients to the end of the follow-up period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05184127
Study type Interventional
Source National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Contact
Status Completed
Phase Phase 2
Start date April 27, 2021
Completion date September 7, 2021

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