Clinical trial NCT05096962: COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Official title: SARS-CoV-2-CZ-PREVAL-II Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: antibodies
cell immunity
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Czech Republic
name: The National Institute of Public Health
name: The Institute of Molecular and Translational Medicine, Czech Republic
name: University Hospital Olomouc
name: Institute for Clinical and Experimental Medicine
name: Thomayer University Hospital
name: Czech Academy of Sciences
name: Palacky University
First posted: 2021-10-27
Enrollment: 7268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of different cohorts of people. The first cohort, Arm IKEM, is chosen from a database of chronically ill patients and subjects involved in the sociological study of the Czech Academy of Sciences. The second cohort, Arm FTN, is chosen from healthcare workers of the Thomayer University Hospital. The third cohort, Arm Olomouc, is composed of volunteers who participated in the Study SARS-CoV-2-CZ-Preval in May 2020.

All subjects will be contacted by email, phone, or SMS.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies
timeFrame: September-October 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of Health Information and Statistics of the Czech Republic
Study officials:
affiliation: Institute of Molecular nad Translational Medicine
name: Marián Hajdúch, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical and Experimental Medicine
name: Věra Adámková, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomayer University Hospital
name: Markéta Ibrahimová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The National Institute of Public Health
name: Barbora Macková, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Health Information and Statistics of the Czech Republic
name: Ladislav Dušek, Prof.
role: STUDY_DIRECTOR
References: