Estimation of Dynamics of Humoral and Cellular Immunity i... | NCT04649840

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

NCT04649840

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status

Completed

Last Update Posted

Dec 10, 2021Actual

Enrollment

274Actual

Phase

Not provided

Conditions

Covid19

Interventions

Humoral and cellular immunity

Countries

Belarus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Dec 9, 2021Actual

Completion Date

Dec 9, 2021Actual

First Submitted Date

Dec 1, 2020

First Submission Date that Met QC Criteria

Dec 1, 2020

First Posted Date

Dec 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2021

Last Update Posted Date

Dec 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOTHER_GOV

Collaborators

Name	Class
Belarusian State Medical University	OTHER
The Republican Research and Practical Center for Epidemiology and Microbiology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 moderate		moderate COVID-19 associated pneumonia	Diagnostic Test: Humoral and cellular immunity
COVID-19 severe		severe COVID-19 associated pneumonia	Diagnostic Test: Humoral and cellular immunity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Humoral and cellular immunity	Diagnostic Test	Humoral (IgG) and cellular (antigen-specific cells) immunity	COVID-19 moderate COVID-19 severe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The dynamics of humoral and cellular immunity	The dynamics of both humoral and cellular immunity in response to COVID-19 infection	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients recovered from the COVID-19 associated pneumonia (moderate and severe)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrei Hancharou, MD, PHD	Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus		Minsk		220072	Belarus

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007111	Immunity, Cellular

Ancestor Terms

ID	Term
D056704	Adaptive Immunity
D007109	Immunity
D055633	Immune System Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided