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

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Humoral and cellular immunity

• Registration Number: NCT04649840
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief 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

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-02
• Status Verified: 2021-12
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 severe	Humoral and cellular immunity	severe COVID-19 associated pneumonia
COVID-19 moderate	Humoral and cellular immunity	moderate COVID-19 associated pneumonia

Primary Outcome Measures

Name	Time	Method
The dynamics of humoral and cellular immunity	1 year	The dynamics of both humoral and cellular immunity in response to COVID-19 infection

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus