SARS-CoV-2-CZ-PREVAL-II Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7,268
- Locations
- 1
- Primary Endpoint
- Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported