An examination of the study participants will be conducted at two points in time at intervals of 4 months. The examinations essentially comprise the completion of a questionnaire and the collection of a stool sample at home as well as a visit to the study center with a short personal interview and the collection of biosamples. During the duration of the study, the Gutenberg COVID-19 app will request information from the participants; however, participation in the study is also possible without using the app.
Data collection by questionnaire: Prior to the visit at the study center, participants will receive a questionnaire by mail in order to assess their possibly known infection status and the impact of the pandemic. Participants are asked to complete the questionnaire at home and bring it with them to their appointment at the study center. The questionnaire covers the following topics:
Collection of a stool sample: Participants will receive a stool sample set by mail and are asked to bring a stool sample to the first appointment (for testing for antibodies against SARS-CoV-2)
(Duration: approx. 45 minutes)
Briefing (1st visit only): During the first visit to the study center, there will be a detailed briefing on the course of the study and all its essential contents. The participants will have the opportunity to ask questions. After obtaining written consent from the participant, the study team will conduct further examinations.
Personal interview: Among other things, the study team will ask the participants questions about their current health status during an interview.
Biosample collection: Using a throat swab, the study team will test participants for acute infection with the coronavirus (SARS-CoV2) and a blood sample will be taken to test whether antibodies against SARS-CoV2 are present. Additionally, blood cells as part of the immune system will be analyzed in regards to composition, activity and - if the participant agrees - DNA (genetic material). The study team will also collect a gum pocket swab as well as tear fluid using paper strips.
App registration (1st visit only): The Gutenberg COVID-19 app will request information weekly or exceptionally every other day for the duration of the study.
To ensure the safety of participants and employees, all measures will be carried out in accordance with a strict hygiene concept.