drugset / Trial / NCT05184127

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

Phase 2 Completed 156 enrolled National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia St. Petersburg Research Institute of Vaccines and Sera · collab

RandomizedParallel-groupOpen-labelTreatment

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 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.

Timeline

Start: 2021-04-27
Primary completion: 2021-09-07
Completion: 2021-09-07

Outcome

Met primary endpoint

paper Patients from the low-dose group achieved the primary endpoint defined by simultaneous achievement of relief of fever, normalization of respiratory rate, reduction of coughing, and oxygen saturation of >95% for 48 h significantly earlier PMID 36721963 ↗

paper median 6 days; 95% confidence interval [CI]: 5-7, HR 1.75, p = .0005 PMID 36721963 ↗

Publications

Khaitov M, Nikonova A, Kofiadi I, Shilovskiy I, Smirnov V, Elisytina O, Maerle A, Shatilov A, Shatilova A, Andreev S, Sergeev I, Trofimov D, Latysheva T, Ilyna N, Martynov A, Rabdano S, Ruzanova E, Savelev N, Pletiukhina I, Safi A, Ratnikov V, Gorelov V, Kaschenko V, Kucherenko N, Umarova I, Moskaleva S, Fabrichnikov S, Zuev O, Pavlov N, Kruchko D, Berzin I, Goryachev D, Merkulov V, Shipulin G, Udin S, Trukhin V, Valenta R, Skvortsova V. Treatment of COVID-19 patients with a SARS-CoV-2-specific siRNA-peptide dendrimer formulation. Allergy. 2023 Jun;78(6):1639-1653. doi: 10.1111/all.15663. Epub 2023 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Convalescent Plasma	Protein / enzyme biologic	—	—
Subject	Favipiravir	Small molecule	—	—
Subject	INTERFERON ALFA-2B	Protein / enzyme biologic	—	—
Subject	MIR 19 ®	Small interfering RNA (siRNA)	1.85 mg	Inhaled
Subject	MIR 19 ®	Small interfering RNA (siRNA)	5.55 mg	Inhaled
Subject	Remdesivir	Small molecule	—	—
Subject	Umifenovir	Small molecule	—	—