NCT04649840

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

December 1, 2020

Last Update Submit

December 9, 2021

Conditions

Covid19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • The dynamics of humoral and cellular immunity

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

    1 year

Study Arms (2)

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

Humoral and cellular immunityDIAGNOSTIC_TEST

Humoral (IgG) and cellular (antigen-specific cells) immunity

COVID-19 moderateCOVID-19 severe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • cancer;
  • drug and alcohol addiction;
  • autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

COVID-19

Interventions

Immunity, Cellular

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adaptive ImmunityImmunityImmune System Phenomena

Study Officials

  • Andrei Hancharou, MD, PHD

    Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 2, 2020

Study Start

October 1, 2020

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Locations

BE(1)