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

• Status: Completed
• Trial end date: 2022-05-03
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we aimed to evaluate the effectiveness and safety of MIR 19 ® in preventing development of moderate and/or severe course of the disease in mild COVID-19 outpatients.

Primary endpoint:

The proportion of patients with the development of moderate or severe COVID-19 disease (in accordance with the criteria specified in the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian Federation, version 14 of 27.12.2021 or current at the time of the study) by the 28th day of observation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

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 oneof 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

• 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.