COVID-19Phase 2/3NCT05783206
Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19
A Phase 2/3 study testing MIR 19 ® and Standard 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
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- MIR 19 ® and Standard therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 1 siteRussia
- Study dates
- 10 Feb 2022to 28 Jul 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
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 Adult Outpatients With Mild COVID-19.
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.
Read the detailed description
This is Phase 2b-3 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® via 7 days treatment in a dose of 5.55 mg/day of participants with symptomatic mild COVID-19 who did not require hospitalisation.
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:
- 5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs.
- 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
- COVID-19
- Being tested
- MIR 19 ®, Standard 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
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 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 (except MIR 19 ®)
| Study group | Role | What they receive |
|---|---|---|
| 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°) Receives: 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°) Receives: Combination Product: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28th day of observation
Secondary outcomes (11)
Etiotropic therapy
The proportion of patients required another etiotropic therapy COVID-19 during the study.
Measured: 28th day of observation
Severity of COVID-19 symptoms
Assessment of the severity of COVID-19 symptoms (nasal congestion, sore throat, shortness of breath, cough, weakness, myalgia, headache, chills, fever, nausea, vomiting, diarrhea, anosmia, ageusia) according to the patient's diary.
Measured: 28th day of observation
Results of polymerase chain reaction (PCR)
The proportion of patients with negative PCR to SARS-CoV-2 at visits 4, 5
Measured: 28th day of observation
Improvement / disappearance of COVID-19 symptoms
Time to clinical improvement / disappearance of symptoms according to the scale of assessment of the severity of symptoms of the disease
Measured: 28th day of observation
Duration of COVID-19 symptoms
Duration of clinical symptoms of COVID-19 disease (fever, cough, myalgia, weakness, shortness of breath, headache, nausea, stool disorders, loss of appetite, anosmia, ageusia) according to the patient's diary.
Measured: 28th day of observation
Moderate COVID-19
Proportion of patients with moderate COVID-19.
Measured: 28th day of observation
Severe COVID-19
Proportion of patients with severe COVID-19.
Measured: 28th day of observation
Critical COVID-19
Proportion of patients with critical COVID-19
Measured: 28th day of observation
Hospitalization
Proportion of hospitalized patients
Measured: 28th day of observation
Death rate
The proportion of deaths during the study
Measured: 28th day of observation
Worsening of COVID-19 symptoms
The proportion of patients with worsening of COVID-19 clinical symptoms during the study by at least 1 point
Measured: 28th day of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start10 Feb 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 984 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783206
- Sponsor's protocol ID
- 04-SiCoV/KK46-01/22
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. 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 Adult Outpatients With Mild COVID-19.
- ClinicalTrials.gov ID
- NCT05783206
- Acronym / sponsor ID
- 04-SiCoV/KK46-01/22
- Conditions
- COVID-19
- Keywords
- COVID-19, siRNA, SARS-CoV-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- National Research Center - Institute of Immunology Federal Medical-Biological Agency of RussiaUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 24 Mar 2023 (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.
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.
Detailed description
This is Phase 2b-3 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® via 7 days treatment in a dose of 5.55 mg/day of participants with symptomatic mild COVID-19 who did not require hospitalisation.
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:
- 5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs.
- 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.
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 ®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°) |
| Standard therapy | Active comparator | Combination Product: Standard therapyStandard 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°) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
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 ®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. | Drug | MIR 19 ® |
| Standard 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 (except MIR 19 ®) | Combination product | Standard therapy |
Primary outcome
Moderate or severe COVID-19
Time frame: 28th day of observation
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)
11 secondary outcomes
Etiotropic therapy
Time frame: 28th day of observation
Severity of COVID-19 symptoms
Time frame: 28th day of observation
Results of polymerase chain reaction (PCR)
Time frame: 28th day of observation
Improvement / disappearance of COVID-19 symptoms
Time frame: 28th day of observation
Duration of COVID-19 symptoms
Time frame: 28th day of observation
Moderate COVID-19
Time frame: 28th day of observation
Severe COVID-19
Time frame: 28th day of observation
Critical COVID-19
Time frame: 28th day of observation
Hospitalization
Time frame: 28th day of observation
Death rate
Time frame: 28th day of observation
Worsening of COVID-19 symptoms
Time frame: 28th day of observation
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 27 Dec 2023.
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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 2/3 study testing MIR 19 ® and Standard 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 6 inclusion and 20 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 27 Dec 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Moderate or severe COVID-19 (time frame: 28th day of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.