COVID-19: SARS-CoV-2-CZ-PREVAL-II Study

NCT05096962 | Completed

• 1 other identifier: 2021/2
• Study Type: observational
• Target: 7,268
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

antibodies; cell immunity

Outcome Measures

Primary Outcomes (1)

• Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies

  The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.

  September-October 2021

Study Arms (3)

Arm IKEM

Arm IKEM (Institute for Clinical and Experimental Medicine) is represented by two subcohorts: * participants with chronic illness (adults only), which are part of the research project of the Institute of Clinical and Experimental Medicine (the expected number of participants in the study - 3 000) * healthy subjects from the Study of Czech Academy of Science, who are following up in the Institute of Clinical and Experimental Medicine (the expected number of subjects in the study - 2000) The subjects will be contacted based on the Hospital study database.

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity

Arm FTN

Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800).

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity

Arm Olomouc

Arm Olomouc is represented by participants, who participated in the Study "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020 and at the same time subjects who will be willing to participate in this study. The involvement of subjects from two localities is expected: * Olomouc * Litovel, Uničov and Červenka. The expected number of subjects in the study is approximately 2500.

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity

Interventions

Quantitative analysis of SARS-CoV-2 antibodies DIAGNOSTIC_TEST

The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).

Arm FTN; Arm IKEM; Arm Olomouc

Cellular immunity DIAGNOSTIC_TEST

Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.

Arm FTN; Arm IKEM; Arm Olomouc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of different cohorts of people. The first cohort, Arm IKEM, is chosen from a database of chronically ill patients and subjects involved in the sociological study of the Czech Academy of Sciences. The second cohort, Arm FTN, is chosen from healthcare workers of the Thomayer University Hospital. The third cohort, Arm Olomouc, is composed of volunteers who participated in the Study SARS-CoV-2-CZ-Preval in May 2020. All subjects will be contacted by email, phone, or SMS.

You may qualify if:

• signed Informed consent
• willingness to complete the study questionnaire
• demographic criteria - age 18 years old and more
• clinical criteria - without acute health problems
• time criteria - sample collection in the defined period time

You may not qualify if:

• none

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator
• The National Institute of Public Health: collaborator
• The Institute of Molecular and Translational Medicine, Czech Republic: collaborator
• University Hospital Olomouc: collaborator
• Institute for Clinical and Experimental Medicine: collaborator
• Thomayer University Hospital: collaborator
• Czech Academy of Sciences: collaborator
• Palacky University: collaborator

Study Sites (1)

Institute of Health Information and Statistics of the Czech Republic

Prague, 128 01, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma sampling will be archived in the biobank for subsequent analyses.

MeSH Terms

Conditions

COVID-19

Interventions

Immunity, Cellular

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adaptive Immunity; Immunity; Immune System Phenomena

Study Officials

• Marián Hajdúch, Assoc. Prof.

  Institute of Molecular nad Translational Medicine

  PRINCIPAL INVESTIGATOR

• Věra Adámková, Prof.

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

• Markéta Ibrahimová, Ph.D.

  Thomayer University Hospital

  PRINCIPAL INVESTIGATOR

• Barbora Macková, M.D.

  The National Institute of Public Health

  PRINCIPAL INVESTIGATOR

• Ladislav Dušek, Prof.

  Institute of Health Information and Statistics of the Czech Republic

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 27, 2021
• Study Start: September 13, 2021
• Primary Completion: October 31, 2021
• Study Completion: February 24, 2022
• Last Updated: November 28, 2022

Record last verified: 2021-10

Locations

CZ (1)