Coronavirus InfectionsPhase 3NCT05407142
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac)
A Phase 3 study testing CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS" in people with Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 10 sites in Russia.
Trial summary
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products"… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Vaccine
- What is being tested?
- CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,000 participants
- Where
- 10 sitesRussia
- Study dates
- 7 Jul 2021to 29 Dec 2023
- Phase
- Phase 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must meet the following inclusion criteria:
- Type of participants Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.
- Age at the time of signing the Informed Consent from ≥ 18 to < 60 years.
- Paul Male or female.
- The volunteers of the study group must meet the following additional inclusion criteria:
- Written Informed consent of volunteers to participate in a clinical trial.
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- Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits).
- For women capable of childbirth - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Women should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile, or in a postmenopausal state.
- For men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile.
Who cannot join
- Volunteers cannot be included in the study if any of the following criteria are present:
- SARS-CoV-2 infection
- A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
- Diseases or medical conditions
- Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems.
- Is registered at the dispensary for tuberculosis, leukemia, oncological diseases, autoimmune diseases.
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- Any confirmed or suspected immunosuppressive or immunodeficiency condition in the anamnesis.
- Splenectomy in the anamnesis.
- Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l) according to anamnesis.
- Anorexia.
- Prior or concomitant therapy
- Vaccination with any vaccine carried out within 30 days before vaccination / the first dose of the studied vaccine or planned administration within 30 days after vaccination / the last dose of the studied vaccine.
- Prior vaccination with an experimental or registered vaccine that may affect the interpretation of the study data (any coronavirus or SARS vaccines).
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs (immunoregulatory peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon) during the six months preceding the study, according to anamnesis.
- Treatment with glucocorticosteroids (≥ 20 mg of prednisone, or an analog, for more than 15 days during the last month).
- Volunteers who received immunoglobulin preparations or blood transfusion during the last 3 months before the start of the study according to anamnesis.
- Other non-inclusion criteria
- Pregnancy or breast-feeding. Participation in any other clinical trial within the last 3 months.
- Volunteers of the study group cannot be included in the study if any of the following criteria are present:
- Diseases or medical conditions
- Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
- Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.)•
- Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
- The axillary temperature at the time of vaccination is more than 37.0 ° C.
- Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis.
- Donation of blood or plasma (in the amount of 450 ml or more) less than 2 months before inclusion in the study.
- Withdrawal of Informed consent by a volunteer;
- The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
- Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
- The established fact of pregnancy before the second vaccination;
- The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;
- For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites, 9 recruiting
- Recruiting
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
Kirov, 610027
Nadezhda Yagovkina, M.D. Ph.D, +79127288622, nad0511ya@rambler.ru
Nadezhda Yagovkina, M.D. Ph.D
- Recruiting
RUSAL Medical Center LLC
Krasnoyarsk, 660111
Olga Rumyantseva, M.D., +74953664429, olrum@bk.ru
Olga Rumyantseva, M.D.
- Recruiting
FSBI NIIVS named after I.I. Mechniko
Moscow, 105064
Michael Kostinov, M.D. D.Sc., +74959174149, vaccinums@gmail.ru
Michael Kostinov, M.D. D.Sc.
- Active, not recruiting
GBUZ "State Design Bureau named after D.D. Pletnev DZM"
Moscow, 105077
- Recruiting
"Scientific Research Institute of Occupational Medicine named after Academician N.F. Izmerov" (FGBNU "Research Institute of MT")
Moscow, 105275
Irina Feldblum, M.D. D.Sc., +73422181668, irinablum@mail.ru
Irina Feldblum
- Recruiting
CHUZ "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
Moscow, 109386
Vladimir Popov, M.D., +74955313055, clinpharmcb6@mail.ru
Vladimir Popov, M.D.
- Recruiting
Limited Liability Company "H-Clinic" (LLC "H-Clinic")
Moscow, 127083
Nataly Voronkova, M.D. Ph.D.
Nataly Voronkova, M.D. Ph.D.
- Recruiting
JSC "Medical services" CDL named after N.A.Semashko
Moscow, 129329
Uruzmag Tomaev, M.D., +76983786656, umtomaev@mail.ru
Uruzmag Tomaev, M.D.
- Recruiting
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Russia, 108819, 108819
Andrew Malkin, M.D., Ph.D, MBA, +79031542117, andrew.malkin@chumakovs.su
Anastasia Korduban, +79652162032, korduban_ak@chumakovs.su
- Recruiting
Mmc Sogaz Llc
Saint Petersburg, 191186
Andrew Obrezan, M.D., +7 8124068888, obrezanI@yandex.ru
Andrew Obrezan, M.D.
About this study
Official title: An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years (Clinical Trials, Phase III)
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
Read the detailed description
The study group is planned to screen a maximum of 32,000 volunteers inclusive, of which it is planned to include 3,500 men and women aged 18 to 60 years who meet the criteria for inclusion in the study and do not have non-inclusion criteria.
The study group consisted of 3,500 volunteers who received the CoviVac vaccine
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml).
Cohorts:
- The data of the first 1000 volunteers of subgroup 1 will be used to assess the efficacy + safety + immunogenicity of the vaccine under study.
- The data of the next 1100 volunteers of subgroup 1 will be used to analyze the efficacy + safety of the vaccine under study.
Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study
Control group - official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
The data of the control group volunteers will be used to evaluate the effectiveness of the vaccine under study.
- Conditions
- Coronavirus Infections, Vaccine
- Being tested
- CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS", The data from volunteers from the control group
- Keywords
- COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"Biological
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml).
Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
The data from volunteers from the control groupOther
Official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
| Study group | Role | What they receive |
|---|---|---|
| The study group consisted of 3,500 volunteers who received the CoviVac vaccine | Experimental | Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days and revaccinated at 6 months with one dose of the KoviVac vaccine.
Cohort 1 - The first 1000 volunteers of the study group will be used to assess the efficacy + safety + immunogenicity of the vaccine under study.
Cohort 2 - Next 1100 volunteers of the study group will be used to analyze the efficacy + safety of the vaccine under study.
Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study. Receives: Biological: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS" |
| Control group | Other | The data from volunteers from the control group will be used to evaluate the effectiveness of the investigational vaccine. Receives: Other: The data from volunteers from the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficasy assessment
The proportion of vaccinated volunteers who do not have laboratory and clinically confirmed COVID-19 disease within 12 months after the second vaccination for all volunteers
Measured: 12 month
Secondary outcomes (9)
Classification by severity of COVID-19
The proportion of study subjects with mild, moderate, severe and extremely severe COVID-19 that developed within 12 months after receiving the second dose of the vaccine from the total number of vaccinated for all volunteers.
Measured: 12 month
The proportion of study subjects who died
The proportion of study subjects who died as a result of COVID-19 out of the number of cases for all volunteers.
Measured: 12 month
The duration of laboratory and clinically confirmed COVID-19 disease.
The duration of laboratory and clinically confirmed COVID-19 disease
Measured: 12 month
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response in the form of an increase in geometric titers of specific antibodies (SGT) in the neutralization reaction and ELISA reaction." Only in cohort 1 of subgroup 1and subgroup 2.
Measured: 12 month
Titer of specific antibody titer ≥ 4 times baseline Specific antibody titer ≥ 4 times baseline
The proportion of volunteers from the total number of vaccinated / revaccinated with a level of seroconversion (titer of specific antibodies ≥ 4 times from the initial level) in the virus neutralization reaction and the ELISA reaction.
Only in cohort 1 of subgroup 1 and subgroup 2.
Measured: 12 month
The level of γ-IFN and the subpopulation composition of T-lymphocytes.
The level of γ-IFN and the subpopulation composition of T-lymphocytes. Only in cohort 1 of subgroup 1 and subgroup 2.
Measured: 12 month
Safety assessment
Frequency of occurrence of serious adverse events during the study.
Measured: 12 month
Safety assessment
Frequency of occurrence, type and association with vaccination of adverse events during the study.
Measured: 12 month
Safety assessment
Cases of early termination of volunteers' participation in the study due to the development of frequency incidence of adverse /serious frequency of adverse events associated with the use of research drugs.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start7 Jul 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407142
- Sponsor's protocol ID
- № VKI-III-04/21
- Status last verified
- Feb 2023
- First submitted
- 24 May 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years (Clinical Trials, Phase III)
- ClinicalTrials.gov ID
- NCT05407142
- Acronym / sponsor ID
- № VKI-III-04/21
- Conditions
- Coronavirus Infections, Vaccine
- Keywords
- COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29,000 participants (estimated)
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 7 Jun 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.
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
Detailed description
The study group is planned to screen a maximum of 32,000 volunteers inclusive, of which it is planned to include 3,500 men and women aged 18 to 60 years who meet the criteria for inclusion in the study and do not have non-inclusion criteria.
The study group consisted of 3,500 volunteers who received the CoviVac vaccine
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml).
Cohorts:
- The data of the first 1000 volunteers of subgroup 1 will be used to assess the efficacy + safety + immunogenicity of the vaccine under study.
- The data of the next 1100 volunteers of subgroup 1 will be used to analyze the efficacy + safety of the vaccine under study.
Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study
Control group - official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
The data of the control group volunteers will be used to evaluate the effectiveness of the vaccine under study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group consisted of 3,500 volunteers who received the CoviVac vaccine | Experimental | Biological: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days and revaccinated at 6 months with one dose of the KoviVac vaccine. Cohort 1 - The first 1000 volunteers of the study group will be used to assess the efficacy + safety + immunogenicity of the vaccine under study. Cohort 2 - Next 1100 volunteers of the study group will be used to analyze the efficacy + safety of the vaccine under study. Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study. |
| Control group | Other | Other: The data from volunteers from the control groupThe data from volunteers from the control group will be used to evaluate the effectiveness of the investigational vaccine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteers must meet the following inclusion criteria:
- Type of participants Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.
- Age at the time of signing the Informed Consent from ≥ 18 to < 60 years.
- Paul Male or female.
- Written Informed consent of volunteers to participate in a clinical trial.
Key exclusion criteria (32 listed)
- Volunteers cannot be included in the study if any of the following criteria are present:
- SARS-CoV-2 infection
- A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
- Diseases or medical conditions
- Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems.
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 |
|---|---|---|
| CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml). Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. | Biological | The study group consisted of 3,500 volunteers who received the CoviVac vaccine |
| The data from volunteers from the control groupOfficial data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals. | Other | Control group |
Primary outcome
Efficasy assessment
Time frame: 12 month
The proportion of vaccinated volunteers who do not have laboratory and clinically confirmed COVID-19 disease within 12 months after the second vaccination for all volunteers
9 secondary outcomes
Classification by severity of COVID-19
Time frame: 12 month
The proportion of study subjects who died
Time frame: 12 month
The duration of laboratory and clinically confirmed COVID-19 disease.
Time frame: 12 month
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response
Time frame: 12 month
Titer of specific antibody titer ≥ 4 times baseline Specific antibody titer ≥ 4 times baseline
Time frame: 12 month
The level of γ-IFN and the subpopulation composition of T-lymphocytes.
Time frame: 12 month
Safety assessment
Time frame: 12 month
Safety assessment
Time frame: 12 month
Safety assessment
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS" in people with Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 10 sites 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 9 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydar Ishmukhametov, M.D.,Prof.,Assoc.Mem.of RAS (+7(495)841-9002, sue_polio@chumakovs.su), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficasy assessment (time frame: 12 month). 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 8 Feb 2023.