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

NCT05184127 | Completed Phase 2 DMC

• 1 other identifier: SiCoV/KK46- 2021_CSR
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19

Keywords

COVID-19; siRNA; SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• Relief of fever

  Reduction in axillary temperature below 37 °C without antipyretic drugs use

  Within 14 days

• Respiratory rate

  Respiratory rate ≤ 22 per minute

  Within 14 days

• Oxygen saturation

  SpO2 \> 94%

  Within 14 days

• Severity of cough

  Severity in a patient's cough no more than 1 point on a four-point scale

  Within 14 days

Study Arms (2)

MIR 19 ®

EXPERIMENTAL

Study participants from experimental groups, in addition to standard COVID-19 therapy, received the MIR 19 ® (2 inhalations per day with a single dose of 1.85 or 5.55 mg at intervals of 7-8 hours for 14 days).The standard therapy in this group included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b

Drug: MIR 19 ®; Combination Product: Standard COVID-19 therapy

Standard COVID-19 therapy

ACTIVE COMPARATOR

In the comparison group, therapy was carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection.The standard therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b.

Combination Product: Standard COVID-19 therapy

Interventions

MIR 19 ® DRUG

Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.

MIR 19 ®

Standard COVID-19 therapy COMBINATION_PRODUCT

Therapy carried out in accordance with the current version of the temporary methodological recommendations of the Ministry of Health of the Russian Federation for the treatment of COVID-19 infection. This therapy included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b

MIR 19 ®; Standard COVID-19 therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia: lead
• St. Petersburg Research Institute of Vaccines and Sera: collaborator

Study Sites (1)

NRC Institute of Immunology FMBA

Moscow, 115478, Russia

Location

Related Publications (1)

• 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.

  PMID: 36721963 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 11, 2022
• Study Start: April 27, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

RU (1)