Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19
NCT ID: NCT05783206
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
984 participants
INTERVENTIONAL
2022-02-10
2023-07-28
Brief Summary
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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.
Detailed Description
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The MIR 19® is a complex of siRNA, targeting Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase (RdRp) and peptide dendrimer (KK-46).
This study involved 2 cohorts who received:
1. 5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs.
2. Standard therapy which included symptomatic treatment as well as etiotropic drugs except MIR 19 ®.
All subjects will undergo scheduled safety and efficacy assessments as outpatients to the end of the follow-up period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MIR 19 ®
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°)
MIR 19 ®
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.
Standard therapy
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°)
Standard therapy
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 ®)
Interventions
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MIR 19 ®
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.
Standard therapy
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 ®)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* History of alcohol, drug or chemical abuse
* Previous hospitalizations associated with the development of moderate and severe COVID-19.
* Mental illness.
* Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) up to 14 days before participating in the study, vaccination against SARS-CoV-2 less than 4 weeks before randomization.
* Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.
18 Years
ALL
No
Sponsors
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National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
OTHER
Responsible Party
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Locations
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NRC Institute of Immunology FMBA
Moscow, , Russia
Countries
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Other Identifiers
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04-SiCoV/KK46-01/22
Identifier Type: -
Identifier Source: org_study_id