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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184127
• Other study ID #: SiCoV/KK46- 2021_CSR
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: January 2022
• Source: National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 1. standard therapy which included symptomatic treatment as well as etiotropic drugs such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon α-2b. 2. 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. 3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?, 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• MIR 19 ®
Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.

Combination Product:
• Standard COVID-19 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 such as Favipiravir, Umifenovir, Remdesivir, convalescent plasma and interferon a-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 a-2b

Locations

Country	Name	City	State
Russian Federation	NRC Institute of Immunology FMBA	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia	St. Petersburg Research Institute of Vaccines and Sera

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of fever	Reduction in axillary temperature below 37 °C without antipyretic drugs use	Within 14 days
Primary	Respiratory rate	Respiratory rate = 22 per minute	Within 14 days
Primary	Oxygen saturation	SpO2 > 94%	Within 14 days
Primary	Severity of cough	Severity in a patient's cough no more than 1 point on a four-point scale	Within 14 days