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

Completed

• Conditions: COVID-19; SARS-CoV-2 Infection
• Interventions: Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic Test: Cellular immunity

• Registration Number: NCT05096962
• Lead Sponsor: Institute of Health Information and Statistics of the Czech Republic

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.

Detailed Description

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 four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020.

The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19.

Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein.

The secondary aims of the study are:

* quantitative analysis of cellular immunity and the other relevant markers,

* estimation of the proportion of participants with asymptomatic COVID-19 infection

* quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.

Study Timeline

• Study Start: 2021-09-13
• Status Verified: 2021-10
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-27
• Primary Completion: 2021-10-31
• Study Completion: 2022-02-24
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7268

Inclusion Criteria

• 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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm Olomouc	Quantitative analysis of SARS-CoV-2 antibodies	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.
Arm IKEM	Cellular immunity	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.
Arm FTN	Cellular immunity	Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800).
Arm Olomouc	Cellular immunity	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.
Arm IKEM	Quantitative analysis of SARS-CoV-2 antibodies	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.
Arm FTN	Quantitative analysis of SARS-CoV-2 antibodies	Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800).

Primary Outcome Measures

Name	Time	Method
Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies	September-October 2021	The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.

Trial Locations

Locations (1)

Institute of Health Information and Statistics of the Czech Republic; 🇨🇿 Prague, Czechia