COVID-19Phase 2NCT05184127
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Moderate COVID-19
A Phase 2 study testing MIR 19 ® and Standard COVID-19 therapy in people with COVID-19, run by National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- MIR 19 ® and Standard COVID-19 therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteRussia
- Study dates
- 27 Apr 2021to 7 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- MIR 19 ®, Standard COVID-19 therapy
- Keywords
- COVID-19, siRNA, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIR 19 ®Drug
Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use.
Standard COVID-19 therapyCombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Combination Product: Standard COVID-19 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of fever
Reduction in axillary temperature below 37 °C without antipyretic drugs use
Measured: Within 14 days
Respiratory rate
Respiratory rate ≤ 22 per minute
Measured: Within 14 days
Oxygen saturation
SpO2 > 94%
Measured: Within 14 days
Severity of cough
Severity in a patient's cough no more than 1 point on a four-point scale
Measured: Within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start27 Apr 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
- Sponsor type
- University, hospital or other
- Collaborators
- St. Petersburg Research Institute of Vaccines and Sera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184127
- Sponsor's protocol ID
- SiCoV/KK46- 2021_CSR
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36721963
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05184127
- Acronym / sponsor ID
- SiCoV/KK46- 2021_CSR
- Conditions
- COVID-19
- Keywords
- COVID-19, siRNA, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Research Center - Institute of Immunology Federal Medical-Biological Agency of RussiaUniversity, hospital or other
- Collaborators
- St. Petersburg Research Institute of Vaccines and Sera
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIR 19 ® | Experimental | Drug: MIR 19 ®, Combination Product: Standard COVID-19 therapyStudy 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 |
| Standard COVID-19 therapy | Active comparator | Combination Product: Standard COVID-19 therapyIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIR 19 ®Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use. | Drug | MIR 19 ® |
| Standard COVID-19 therapyTherapy 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 | Combination product | MIR 19 ®, Standard COVID-19 therapy |
Primary outcome
Relief of fever
Time frame: Within 14 days
Reduction in axillary temperature below 37 °C without antipyretic drugs use
Respiratory rate
Time frame: Within 14 days
Respiratory rate ≤ 22 per minute
Oxygen saturation
Time frame: Within 14 days
SpO2 > 94%
Severity of cough
Time frame: Within 14 days
Severity in a patient's cough no more than 1 point on a four-point scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 36721963Khaitov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIR 19 ® and Standard COVID-19 therapy in people with COVID-19, run by National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of fever (time frame: Within 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.