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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Quantitative analysis of SARS-CoV-2 antibodies; Diagnostic test: Cellular immunity

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 Type: Observational
• Enrollment (Actual): 7268

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 128 01
    • Institute of Health Information and Statistics of the Czech Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm IKEM; 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.	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).; Diagnostic test: Cellular immunity; Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
Arm FTN; Arm FTN (Thomayer University Hospital) is represented by the healthcare staff of the Hospital (the expected number of subjects in the study - 1800).	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).; Diagnostic test: Cellular immunity; Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
Arm Olomouc; 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.	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).; Diagnostic test: Cellular immunity; Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Health Information and Statistics of the Czech Republic
• Collaborators: Institute for Clinical and Experimental Medicine; University Hospital Olomouc; The Institute of Molecular and Translational Medicine, Czech Republic; Palacky University; Thomayer University Hospital; Czech Academy of Sciences; Ministry of Health, Czech Republic; The National Institute of Public Health
• Investigators: Study Director: Ladislav Dušek, Prof., Institute of Health Information and Statistics of the Czech Republic; Principal Investigator: Věra Adámková, Prof., Institute for Clinical and Experimental Medicine; Principal Investigator: Marián Hajdúch, Assoc. Prof., Institute of Molecular nad Translational Medicine; Principal Investigator: Markéta Ibrahimová, Ph.D., Thomayer University Hospital; Principal Investigator: Barbora Macková, M.D., The National Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): February 24, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: antibodies; cell immunity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 2021/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No