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

SARS-CoV-2-CZ-PREVAL-II Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05096962
Enrollment
7268
Registered
2021-10-27
Start date
2021-09-13
Completion date
2022-02-24
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2 Infection

Keywords

antibodies, cell immunity

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.

Interventions

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).

DIAGNOSTIC_TESTCellular immunity

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

Sponsors

Ministry of Health, Czech Republic
CollaboratorOTHER_GOV
The National Institute of Public Health
CollaboratorUNKNOWN
The Institute of Molecular and Translational Medicine, Czech Republic
CollaboratorOTHER
University Hospital Olomouc
CollaboratorOTHER
Institute for Clinical and Experimental Medicine
CollaboratorOTHER_GOV
Thomayer University Hospital
CollaboratorOTHER
Czech Academy of Sciences
CollaboratorOTHER
Palacky University
CollaboratorOTHER
Institute of Health Information and Statistics of the Czech Republic
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026