Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): MIR 19 ®; Standard COVID-19 therapy
Intervention type(s): Drug; Combination Product
Intervention description(s): Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.; Therapy carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection. This therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; siRNA; SARS-CoV-2