NCT05184127

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

Completed Phase 2 Last updated 11 January 2022

What this trial tests

Phase 2 trial testing MIR 19 ® in COVID-19 in 156 participants. Completed in 7 September 2021.

Timeline

27 April 2021

Primary endpoint
7 September 2021

7 September 2021

Quick facts

Lead sponsor	National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	27 April 2021
Primary completion	7 September 2021
Estimated completion	7 September 2021
Sites	1 location across Russia

Drugs / interventions tested

• MIR 19 ® — full drug profile →
• Standard COVID-19 therapy

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Who can join

Adults 18 to 65, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 study is to evaluate the efficacy, safety and daily dose of MIR 19 ® for the treatment of the hospitalized patients with infection caused by SARS-CoV-2 (COVID-19) who did not require treatment in the intensive care unit.

Based on preclinical data studying antiviral effect of MIR 19® in vitro and in vivo (Khaitov M.R. et all 2021), the investigators hypothesized that SARS-CoV-2 inhibition with MIR 19® could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic siRNA: State-of-the-Art and Future Perspectives.
   Friedrich M, Aigner A. · · 2022 · cited 256× · PMID 35997897 · DOI 10.1007/s40259-022-00549-3
2. Where should siRNAs go: applicable organs for siRNA drugs.
   Ahn I, Kang CS, Han J. · · 2023 · cited 100× · PMID 37430086 · DOI 10.1038/s12276-023-00998-y
3. Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
   Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
4. Dendrimers, an Emerging Opportunity in Personalized Medicine?
   Caminade AM. · · 2022 · cited 39× · PMID 36013283 · DOI 10.3390/jpm12081334
5. Dendrimer-Mediated Delivery of DNA and RNA Vaccines.
   Kisakova LA, Apartsin EK, Nizolenko LF, Karpenko LI. · · 2023 · cited 29× · PMID 37111593 · DOI 10.3390/pharmaceutics15041106
6. Dendrimers and Derivatives as Multifunctional Nanotherapeutics for Alzheimer's Disease.
   Moreira DA, Santos SD, Leiro V, Pêgo AP. · · 2023 · cited 18× · PMID 37111540 · DOI 10.3390/pharmaceutics15041054
7. Treatment of COVID-19 patients with a SARS-CoV-2-specific siRNA-peptide dendrimer formulation.
   Khaitov M, Nikonova A, Kofiadi I, Shilovskiy I, et al · · 2023 · cited 18× · PMID 36721963 · DOI 10.1111/all.15663
8. Molecular Therapies in Cardiovascular Diseases: Small Interfering RNA in Atherosclerosis, Heart Failure, and Hypertension.
   Sarzani R, Spannella F, Di Pentima C, Giulietti F, et al · · 2023 · cited 14× · PMID 38203499 · DOI 10.3390/ijms25010328