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

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.

Inclusion criteria

• Men and women over the age of 18 who have been diagnosed with COVID-19 and who need therapy on an outpatient basis according to the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)"by Ministry of Health of the Russian Federation. Version 14 from 12/27/2021.
• Able to give informed consent and attend all study visits
• Duration of the disease from the first symptoms (presence of at least one of the following symptoms: fever, cough, myalgia, weakness, shortness of breath, headache, nausea, stool disorders, loss of appetite) up to the day of screening no more than 5 days.
• Negative pregnancy test for women with preserved reproductive potential
• Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month
• The patient's ability to inhale the experimental drug

Exclusion criteria

• Respiratory rate is more than 22 / min
• Oxygen saturation - SpO2 ≤ 94%.
• Decreased level of consciousness, agitation.
• Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
• Long-term systemic corticosteroid exposure.
• Autoimmune or inflammatory diseases (systemic / localized), as well as oncological diseases.
• Symptoms of moderate, severe or critical COVID-19 at the time of screening
• 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
• 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);
• C-reactive protein (CRP) level > 10 mg/L.
• Participation in other investigational drug or device clinical trials within 90 days prior to screening.
• History of alcohol, drug or chemical abuse
• Previous hospitalizations associated with the development of moderate and severe COVID-19.
• 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 less than 4 weeks before randomization.
• Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.