Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19

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:

• standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.
• 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.
• 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.

Inclusion criteria

• Men or non-pregnant female aged 18 to 65 years hospitalized with moderate COVID-19 infection: body temperature > 37.5 °C; respiratory rate > 22/min; shortness of breath during physical exertion; typical coronavirus-associated chest computed tomography (CT) changes (CT1- CT2); pulse oximetry levels SpO2< 95%.
• Able to give informed consent and attend all study visits
• Positive PCR-test for COVID-19 ≤72 hours prior to randomization
• The patient's ability to inhale the experimental drug
• Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month

Key Exclusion Criteria:

• Fever > 38.5°C.
• Cough severity is less than 1 point on a 4-point scale.
• Respiratory rate > is more than 30 / min
• SpO2 ≤ 93%.
• Decreased level of consciousness, agitation.
• Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
• The need to require mechanical ventilation beyond the screening/ randomization.
• Long-term systemic corticosteroid exposure.
• Autoimmune or inflammatory diseases (systemic / localized).
• Positive blood tests for HIV, hepatitis B and С, syphilis.
• Pregnancy and breast-feeding
• Previous adverse reactions to the active substance and/or excipients included in the drug.
• Any use of anti-viral medications or immunomodulatory agents up to 7 days before participating in the study
• Chronic diseases of the cardiovascular system
• Type 1 diabetes
• The following laboratory parameters are excluded:

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total and direct bilirubin >4 x upper limit of normal (ULN);

• Treatment with any medicine that have a pronounced effects on the blood coagulation system (expect for COVID-19 treatment), including combined oral contraceptives.
• Treatment with any medicine that can affect cardiac conduction
• Participation in other investigational drug or device clinical trials within 90 days prior to screening.
• History of alcohol, drug or chemical abuse.
• Mental illness.
• Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) up to 14 days before participating in the study, vaccination against SARS-CoV-2 , the need for extracorporeal membrane oxygenation.
• Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.