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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
MIR 19 ®
Standard COVID-19 therapy
Sponsored by
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, siRNA, SARS-CoV-2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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%.
  2. Able to give informed consent and attend all study visits
  3. Positive PCR-test for COVID-19 ≤72 hours prior to randomization
  4. The patient's ability to inhale the experimental drug
  5. Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month

Key Exclusion Criteria:

  1. Fever > 38.5°C.
  2. Cough severity is less than 1 point on a 4-point scale.
  3. Respiratory rate > is more than 30 / min
  4. SpO2 ≤ 93%.
  5. Decreased level of consciousness, agitation.
  6. Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
  7. The need to require mechanical ventilation beyond the screening/ randomization.
  8. Long-term systemic corticosteroid exposure.
  9. Autoimmune or inflammatory diseases (systemic / localized).
  10. Positive blood tests for HIV, hepatitis B and С, syphilis.
  11. Pregnancy and breast-feeding
  12. Previous adverse reactions to the active substance and/or excipients included in the drug.
  13. Any use of anti-viral medications or immunomodulatory agents up to 7 days before participating in the study
  14. Chronic diseases of the cardiovascular system
  15. Type 1 diabetes

  16. 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);

  17. Treatment with any medicine that have a pronounced effects on the blood coagulation system (expect for COVID-19 treatment), including combined oral contraceptives.
  18. Treatment with any medicine that can affect cardiac conduction
  19. Participation in other investigational drug or device clinical trials within 90 days prior to screening.
  20. History of alcohol, drug or chemical abuse.
  21. Mental illness.
  22. 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 , the need for extracorporeal membrane oxygenation.
  23. Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.

Sites / Locations

  • NRC Institute of Immunology FMBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIR 19 ®

Standard COVID-19 therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Relief of fever
Reduction in axillary temperature below 37 °C without antipyretic drugs use
Respiratory rate
Respiratory rate ≤ 22 per minute
Oxygen saturation
SpO2 > 94%
Severity of cough
Severity in a patient's cough no more than 1 point on a four-point scale

Secondary Outcome Measures

Full Information

First Posted
January 7, 2022
Last Updated
January 7, 2022
Sponsor
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Collaborators
St. Petersburg Research Institute of Vaccines and Sera
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1. Study Identification

Unique Protocol Identification Number
NCT05184127
Brief Title
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19
Official Title
Open Multicenter Controlled Clinical Trial to Evaluate Safety and Efficacy of Aerosolized MIR 19 ® Inhalation in Patients With Moderate COVID-19 Who Did Not Require Treatment in the Intensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Collaborators
St. Petersburg Research Institute of Vaccines and Sera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is Phase 2 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® in male and female volunteers with symptomatic moderate COVID-19 who did not require treatment in the intensive care unit. The MIR 19® is a complex of siRNA, targeting SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) and peptide dendrimer KK-46. This study involved 3 cohorts who received: standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. 3.7 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. 11.1 mg of the MIR 19 ® via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. All subjects will undergo scheduled safety and efficacy assessments while in the clinical unit and as outpatients to the end of the follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, siRNA, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIR 19 ®
Arm Type
Experimental
Arm Description
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
Arm Title
Standard COVID-19 therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MIR 19 ®
Intervention Description
Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.
Intervention Type
Combination Product
Intervention Name(s)
Standard COVID-19 therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Relief of fever
Description
Reduction in axillary temperature below 37 °C without antipyretic drugs use
Time Frame
Within 14 days
Title
Respiratory rate
Description
Respiratory rate ≤ 22 per minute
Time Frame
Within 14 days
Title
Oxygen saturation
Description
SpO2 > 94%
Time Frame
Within 14 days
Title
Severity of cough
Description
Severity in a patient's cough no more than 1 point on a four-point scale
Time Frame
Within 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Key Exclusion Criteria: 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 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); Treatment with any medicine that have a pronounced effects on the blood coagulation system (expect for COVID-19 treatment), including combined oral contraceptives. Treatment with any medicine that can affect cardiac conduction Participation in other investigational drug or device clinical trials within 90 days prior to screening. History of alcohol, drug or chemical abuse. 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 , the need for extracorporeal membrane oxygenation. Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.
Facility Information:
Facility Name
NRC Institute of Immunology FMBA
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation

12. IPD Sharing Statement

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

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