Covid19NCT04649840
Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients
An observational study of Covid19, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
The goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the SARS-CoV-2 virus at different time intervals, in order to predict the duration of immune protection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Humoral and cellular immunity
- How many people
- 274 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Oct 2020to 9 Dec 2021
- Phase
- Observational
- 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
Study population: Patients recovered from the COVID-19 associated pneumonia (moderate and severe)
Who may be able to join
- patients recovered from the COVID-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial;
Who cannot join
- cancer;
- drug and alcohol addiction;
- autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
The goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the SARS-CoV-2 virus at different time intervals, in order to predict the duration of immune protection
Read the detailed description
- to form study groups of patients (at least 60 patients in total) who have recovered from pneumonia of varying severity caused by the SARS-CoV-2 virus (at least 30 patients in each of the groups of patients who have had pneumonia in moderate and severe forms);
- to investigate the parameters of cellular immunity (the content of antigen-specific T-cells to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia;
- to investigate the indicators of humoral immunity (the content of IgG to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia.
- Conditions
- Covid19
- Being tested
- Humoral and cellular immunity
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humoral and cellular immunityDiagnostic test
Humoral (IgG) and cellular (antigen-specific cells) immunity
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 moderate | moderate COVID-19 associated pneumonia Receives: Diagnostic Test: Humoral and cellular immunity | |
| COVID-19 severe | severe COVID-19 associated pneumonia Receives: Diagnostic Test: Humoral and cellular immunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dynamics of humoral and cellular immunity
The dynamics of both humoral and cellular immunity in response to COVID-19 infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Oct 2020
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University, The Republican Research and Practical Center for Epidemiology and Microbiology
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, MD, PHD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649840
- Sponsor's protocol ID
- IBCE_COVID19_Immunity
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2020
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04649840
- Acronym / sponsor ID
- IBCE_COVID19_Immunity
- Conditions
- Covid19
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University, The Republican Research and Practical Center for Epidemiology and Microbiology
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 2 Dec 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.
The goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the SARS-CoV-2 virus at different time intervals, in order to predict the duration of immune protection
Detailed description
- to form study groups of patients (at least 60 patients in total) who have recovered from pneumonia of varying severity caused by the SARS-CoV-2 virus (at least 30 patients in each of the groups of patients who have had pneumonia in moderate and severe forms);
- to investigate the parameters of cellular immunity (the content of antigen-specific T-cells to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia;
- to investigate the indicators of humoral immunity (the content of IgG to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 moderate | – | Diagnostic Test: Humoral and cellular immunitymoderate COVID-19 associated pneumonia |
| COVID-19 severe | – | Diagnostic Test: Humoral and cellular immunitysevere COVID-19 associated pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recovered from the COVID-19 associated pneumonia (moderate and severe)
Key inclusion criteria (1 listed)
- patients recovered from the COVID-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial;
Key exclusion criteria (3 listed)
- cancer;
- drug and alcohol addiction;
- autoimmune diseases.
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 |
|---|---|---|
| Humoral and cellular immunityHumoral (IgG) and cellular (antigen-specific cells) immunity | Diagnostic test | COVID-19 moderate, COVID-19 severe |
Primary outcome
The dynamics of humoral and cellular immunity
Time frame: 1 year
The dynamics of both humoral and cellular immunity in response to COVID-19 infection
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 10 Dec 2021.
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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.
Andrei Hancharou, MD, PHD study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
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 1 inclusion and 3 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 10 Dec 2021. 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 Belarus. 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.
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?
The dynamics of humoral and cellular immunity (time frame: 1 year). 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 10 Dec 2021.