drugset / Trial / NCT05783206
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19
Phase 2/3
Completed
984 enrolled
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is 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.
Timeline
- Start
- 2022-02-10
- Primary completion
- 2023-07-28
- Completion
- 2023-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MIR 19 ® | Small interfering RNA (siRNA) | 1.85 mg | Inhaled |
| Background | Acetaminophen | Small molecule | 500 mg | — |
| Background | Acetaminophen | Small molecule | 1000 mg | — |
| Background | Interferon-α | Protein / enzyme biologic | — | Intranasal |
| Background | Umifenovir | Small molecule | 200 mg | — |