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NCT04649840 Clinical Trial

Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients

Covid19 Clinical Trial

Official title:
Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04649840
Other study ID # IBCE_COVID19_Immunity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 9, 2021

Study information
Verified date December 2021
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date December 9, 2021
Est. primary completion date December 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients recovered from the COVID-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial; Exclusion Criteria: - cancer; - drug and alcohol addiction; - autoimmune diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Humoral and cellular immunity
Humoral (IgG) and cellular (antigen-specific cells) immunity

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (3)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University, The Republican Research and Practical Center for Epidemiology and Microbiology

Country where clinical trial is conducted

Belarus, 

Outcome
Type Measure Description Time frame Safety issue
Primary The dynamics of humoral and cellular immunity The dynamics of both humoral and cellular immunity in response to COVID-19 infection 1 year
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