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

Institute of Health Information and Statistics of the Czech Republic

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT05096962

2021/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,268 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7,268 participants in 3 patient groups

Arm IKEM

Description:

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.

Treatment:

Diagnostic Test: Cellular immunity

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies

Arm FTN

Description:

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

Treatment:

Diagnostic Test: Cellular immunity

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies

Arm Olomouc

Description:

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.

Treatment:

Diagnostic Test: Cellular immunity

Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies