Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region

The Institute of Molecular and Translational Medicine, Czech Republic

Status: Completed

Conditions: SARS-CoV-2 (COVID-19) Infection; SARS-CoV-2

Treatments: Procedure: Blood sampling; Procedure: Gargle sampling; Other: Questionnaire completion; Diagnostic Test: Body temperature measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07387211

34909

Details and patient eligibility

About

The aim of the study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.

Full description

Study has three study visits. First two visits are three months apart. Second and third visits are five months apart. On each study visit participant will provide venous blood sample and saliva sample obtained by gargling with the use of GARGTEST sampling kit. Participant will also fill in a questionnaire about SARS-CoV-2 infections and vaccinations. Site staff will measure the body temperature of the patient to exclude a patient with an acute infection. Blood sample will be used for the assessment of antibodies and cellular immunity of SARS-CoV-2. Part of the blood will be biobanked for the future SARS-CoV-2 biomarker determination. Gargling sample will be used for the demonstration of the pathogen on mucous membranes. Gargle self-sampling using GARGTEST sampling kit will be done by participants at 14-day intervals between the study visits. For gargle sample RT-PCR (real time polymerase chain reaction) will be done to determine the patogen presence.

Enrollment: 2,484 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participation in the SARS-CoV-2-CZ-PREVAL study and venous blood examined as part of this study
• Signed study informed consent and consent to the processing of personal data
• Adults (age 18 and over)
• Willingness to complete the questionnaire

Exclusion criteria

• Participant with acute health problems

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,484 participants in 1 patient group

Participants of the SARS-CoV-2-CZ-Preval study from the Olomouc region

Other group

Description:

Population of persons involved in the SARS-CoV-2-CZ-Preval study in 2020 in the Olomouc region

Treatment:

Diagnostic Test: Body temperature measurement

Other: Questionnaire completion

Procedure: Gargle sampling

Procedure: Blood sampling