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

NCT05783206 | Completed Phase 2 DMC

• 1 other identifier: 04-SiCoV/KK46-01/22
• Study Type: interventional
• Target: 984
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; siRNA; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Moderate or severe COVID-19

  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)

  28th day of observation

Secondary Outcomes (11)

• Etiotropic therapy

  28th day of observation

• Severity of COVID-19 symptoms

  28th day of observation

• Results of polymerase chain reaction (PCR)

  28th day of observation

• Improvement / disappearance of COVID-19 symptoms

  28th day of observation

• Duration of COVID-19 symptoms

  28th day of observation

Study Arms (2)

MIR 19 ®

EXPERIMENTAL

MIR 19 ® was used in a single dose of 1.85 mg for 3 inhalations per day at intervals of 6-7 hours for 7 days in addition to standard therapy without use of any etiotropic drugs. Standard therapy included: \- paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)

Drug: MIR 19 ®

Standard therapy

ACTIVE COMPARATOR

Standard therapy included: * umifenovir (Arbidol®) - 200 mg 4 times per day for 7 days * interferon-α, intranasal forms (Grippferon®),spray - in accordance with the instructions. * paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)

Combination Product: Standard therapy

Interventions

MIR 19 ® DRUG

MIR 19 ® contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use. In the experimental groups treated with MIR 19 ®, the therapy included symptomatic treatment without use of any etiotropic drugs.

MIR 19 ®

Standard 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 (except MIR 19 ®)

Standard therapy

Eligibility Criteria

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

You may qualify if:

• Men and women over the age of 18 who have been diagnosed with COVID-19 and who need therapy on an outpatient basis according to the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)"by Ministry of Health of the Russian Federation. Version 14 from 12/27/2021.
• Able to give informed consent and attend all study visits
• Duration of the disease from the first symptoms (presence of at least one of the following symptoms: fever, cough, myalgia, weakness, shortness of breath, headache, nausea, stool disorders, loss of appetite) up to the day of screening no more than 5 days.
• Negative pregnancy test for women with preserved reproductive potential
• Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month
• The patient's ability to inhale the experimental drug

You may not qualify if:

• Respiratory rate is more than 22 / min
• Oxygen saturation - SpO2 ≤ 94%.
• Decreased level of consciousness, agitation.
• Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
• Long-term systemic corticosteroid exposure.
• Autoimmune or inflammatory diseases (systemic / localized), as well as oncological diseases.
• Symptoms of moderate, severe or critical COVID-19 at the time of screening
• 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
• 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);
• C-reactive protein (CRP) level \> 10 mg/L.
• Participation in other investigational drug or device clinical trials within 90 days prior to screening.

Sponsors & Collaborators

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

Study Sites (1)

NRC Institute of Immunology FMBA

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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: March 22, 2023
• First Posted: March 24, 2023
• Study Start: February 10, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

RU (1)