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

Completed

• Conditions: COVID-19; SARS-CoV-2 Infection

• 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

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