Back to resultsEvaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, siRNA, SARS-CoV-2
Eligibility Criteria
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.
Sites / Locations
- NRC Institute of Immunology FMBA
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MIR 19 ®
Standard therapy
MIR 19 ® was used in a single dose of 1.85 mg for 3 inhalations per day at intervals of 6-7 hours for 7 days in addition to standard therapy without use of any etiotropic drugs. Standard therapy included: - paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)
Standard therapy included: umifenovir (Arbidol®) - 200 mg 4 times per day for 7 days interferon-α, intranasal forms (Grippferon®),spray - in accordance with the instructions. paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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