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NCT05096962 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
SARS-CoV-2-CZ-PREVAL-II Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05096962
Other study ID # 2021/2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2021
Est. completion date February 24, 2022

Study information
Verified date October 2021
Source Institute of Health Information and Statistics of the Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 7268
Est. completion date February 24, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Quantitative analysis of SARS-CoV-2 antibodies
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).
• Cellular immunity
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.

Locations
Country Name City State
Czechia Institute of Health Information and Statistics of the Czech Republic Prague

Sponsors (9)
Lead Sponsor Collaborator
Institute of Health Information and Statistics of the Czech Republic Czech Academy of Sciences, Institute for Clinical and Experimental Medicine, Ministry of Health, Czech Republic, Palacky University, The Institute of Molecular and Translational Medicine, Czech Republic, The National Institute of Public Health, Thomayer University Hospital, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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