Status:
COMPLETED
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19
Lead Sponsor:
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Collaborating Sponsors:
St. Petersburg Research Institute of Vaccines and Sera
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05184127
Start Date
April 27 2021
End Date
September 7 2021
Last Update
January 11 2022
Active Locations (1)
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1
NRC Institute of Immunology FMBA
Moscow, Russia, 115478