Covid19 PreventionPhase 3RESISTNCT04530396
Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19
A Phase 3 study testing Gam-COVID-Vac in people with Covid19 Prevention, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 23 sites in Russia.
Trial summary
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2… Read more about this study
- Who is it for?
- Ages 18 to 111 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19 Prevention
- What is being tested?
- Gam-COVID-Vac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33,758 participants
- Where
- 23 sitesRussia
- Study dates
- 7 Sep 2020to 1 May 2021
- 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 111 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent of a subject to participate in the trial
- Males and females aged ≥18 y.o.;
- Negative HIV, hepatitis, and syphilis test results
- Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
- Negative COVID-2019 PCR test result at the screening visit
- No COVID-2019 in the past medical history
Show all 13Show fewer
- No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)
- Consent to use effective contraception methods during the trial
- Negative urine pregnancy test at the screening visit (for child-bearing age women)
- Negative drugs or psychostimulants urine test at the screening visit
- Negative alcohol test at the screening visit
- No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history
- No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
Who cannot join
- Any vaccination/immunization within 30 days before the enrollment;
- Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- Immunosuppressors therapy finished within 3 months before the enrollment
- Pregnancy or breast-feeding
- Acute coronary syndrome or stroke suffered less than one year before the enrollment
- Tuberculosis, chronic systemic infections
Show all 19Show fewer
- Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day
- Neoplasms in the past medical history (ICD codes C00-D09)
- Donated blood or plasma (450+ ml) within 2 months before the enrollment
- History of splenectomy;
- Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past medical history within 6 months before the enrollment
- Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
- Anorexia, protein deficiency of any origin
- Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
- Alcohol or drug addiction in the past medical history
- Participation in any other interventional clinical trial
- Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
- Study center staff or other employees directly involved in the trial, or their families.
- If a subject has any contraindications to vaccination based on the Guidelines on Detection, Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Russia23 sites
ARCHIMED V Clinic of new medical technologies limited liability company
Moscow
Hadassah LTD
Moscow
Medsi Group of companies joint-stock company"
Moscow
Niarmedic Plus
Moscow
State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department"
Moscow
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department
Moscow
State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow"
Moscow
State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow"
Moscow
About this study
Official title: Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Read the detailed description
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.
The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.
The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo
Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits may be remote, through the telemedicine consultation (TMC).
Additionally, the trial subjects will be able to have remote consultations with the physician through the TMC.
Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters listed below:
Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8 cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520 subjects) ×3 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific antibodies(9,520 subjects) ×3
Blood sampling will be performed on the day of injecting the first dose of the study drug/placebo immediately prior to the study drug administration Blood sampling for immunogenicity parameters assessment will be only carried out in specially selected study centers.
Blood samples will be taken from 9,520 trial subjects. All four immunogenicity parameters may be assessed in one trial subject.
Trial subjects data will be collected using electronic case report forms and electronic questionnaires to be filled by trial subjects.
- Conditions
- Covid19 Prevention
- Being tested
- Gam-COVID-Vac, placebo
- Keywords
- COVID-19, vector vaccine, SARS-CoV-2, adenoviral vector
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-VacBiological
vaccine for intramuscular injection
placeboOther
placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Primary Group | Experimental | Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S) Receives: Biological: Gam-COVID-Vac |
| Control Group | Placebo comparator | placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21 Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measured: through the whole study, an average of 180 days
Secondary outcomes (7)
the severity of the clinical course of COVID-19
Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measured: through the whole study, an average of 180 days
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measured: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Changing of antigen-specific cellular immunity level
Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo
Measured: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose
Changing of of virus neutralizing antibody titer
Geometric mean virus-neutralizing antibodies titer
Measured: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Incidence of adverse events in trial subjects
Incidence of adverse events in trial subjects compared to placebo
Measured: through the whole study, an average of 180 days
Severity of adverse events in trial subjects
Severity of adverse events in trial subjects compared to placebo
Measured: through the whole study, an average of 180 days
estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2
Percentage of study subjects with antibodies
to the N-protein of the SARS - CoV-2 virus that appeared after
vaccination
Measured: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start7 Sep 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
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 Covid19 PreventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33,758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- Government of the city of Moscow, CRO: Crocus Medical BV
- Responsible party
- Sponsor
- Investigators
- Elena Smolyarchuk, MD, PhD, Study chair, Study CoordinatorSergey Zyryanov, MD, PhD, Study chair, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530396
- Sponsor's protocol ID
- 04-Gam-COVID-Vac-2020
- Acronym
- RESIST
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.
PubMed 33545094
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
- ClinicalTrials.gov ID
- NCT04530396
- Acronym / sponsor ID
- RESIST / 04-Gam-COVID-Vac-2020
- Conditions
- Covid19 Prevention
- Keywords
- COVID-19, vector vaccine, SARS-CoV-2, adenoviral vector
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33,758 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Government of the city of Moscow, CRO: Crocus Medical BV
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Aug 2020 (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.
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Detailed description
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.
The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.
The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo
Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits may be remote, through the telemedicine consultation (TMC).
Additionally, the trial subjects will be able to have remote consultations with the physician through the TMC.
Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters listed below:
Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8 cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520 subjects) ×3 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific antibodies(9,520 subjects) ×3
Blood sampling will be performed on the day of injecting the first dose of the study drug/placebo immediately prior to the study drug administration Blood sampling for immunogenicity parameters assessment will be only carried out in specially selected study centers.
Blood samples will be taken from 9,520 trial subjects. All four immunogenicity parameters may be assessed in one trial subject.
Trial subjects data will be collected using electronic case report forms and electronic questionnaires to be filled by trial subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Primary Group | Experimental | Biological: Gam-COVID-VacGam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S) |
| Control Group | Placebo comparator | Other: placeboplacebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21 |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent of a subject to participate in the trial
- Males and females aged ≥18 y.o.;
- Negative HIV, hepatitis, and syphilis test results
- Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
- Negative COVID-2019 PCR test result at the screening visit
Key exclusion criteria (19 listed)
- Any vaccination/immunization within 30 days before the enrollment;
- Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- Immunosuppressors therapy finished within 3 months before the enrollment
- Pregnancy or breast-feeding
- Acute coronary syndrome or stroke suffered less than one year before the enrollment
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 |
|---|---|---|
| Gam-COVID-Vacvaccine for intramuscular injection | Biological | Primary Group |
| placeboplacebo comparator | Other | Control Group |
Primary outcome
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
Time frame: through the whole study, an average of 180 days
Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
7 secondary outcomes
the severity of the clinical course of COVID-19
Time frame: through the whole study, an average of 180 days
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Time frame: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Changing of antigen-specific cellular immunity level
Time frame: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose
Changing of of virus neutralizing antibody titer
Time frame: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Incidence of adverse events in trial subjects
Time frame: through the whole study, an average of 180 days
Severity of adverse events in trial subjects
Time frame: through the whole study, an average of 180 days
estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2
Time frame: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 33545094Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.
- Individual participant dataSharing planned: No
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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.
Elena Smolyarchuk, MD, PhD study chair
Study Coordinator
Sergey Zyryanov, MD, PhD study chair
Study Coordinator
23 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 Gam-COVID-Vac in people with Covid19 Prevention, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 23 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 13 inclusion and 19 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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?
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?
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose (time frame: through the whole study, an average of 180 days). 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 NCT04530396, 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 22 Jan 2021.