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

Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)
Overall Status
Completed
CT.gov ID
NCT04649840
Collaborator
Belarusian State Medical University (Other), The Republican Research and Practical Center for Epidemiology and Microbiology (Other)
274
1
14.3
19.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Humoral and cellular immunity

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

Study Type:
Observational
Actual Enrollment :
274 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Dec 9, 2021
Actual Study Completion Date :
Dec 9, 2021

Arms and Interventions

Arm Intervention/Treatment
COVID-19 moderate

moderate COVID-19 associated pneumonia

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

COVID-19 severe

severe COVID-19 associated pneumonia

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

Outcome Measures

Primary Outcome Measures

  1. The dynamics of humoral and cellular immunity [1 year]

    The dynamics of both humoral and cellular immunity in response to COVID-19 infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk Belarus 220072

Sponsors and Collaborators

  • 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

Investigators

  • Study Director: Andrei Hancharou, MD, PHD, Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier:
NCT04649840
Other Study ID Numbers:
  • IBCE_COVID19_Immunity
First Posted:
Dec 2, 2020
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2021