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Completed

NCT Number: NCT05096962

COVID-19: 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Health Information and Statistics of the Czech Republic

Prague, 128 01, Czechia

About this 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative analysis of SARS-CoV-2 antibodies

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies

    Time frame: September-October 2021

    The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts.

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 27, 2021
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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