Course of COVID-19 in vaccinated and unvaccinated individuals

• Conditions: U07.1; COVID-19, virus identified

• Registration Number: DRKS00024739
• Lead Sponsor: niversitätsklinikum Erlangen, Virologisches Institut - Klinische und Molekulare Virologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• Informed consent; in the event of inability to give consent, submission of the declaration by a representative in the case of presumably positive will of the proband
• Sufficient knowledge of German to understand the subject information and answer the questionnaires
• SARS-CoV-2 infection detected by at least one positive SARS-CoV-2 RNA detection using PCR in a respiratory sample. The first positive SARS result must not be more than two weeks ago.
• Vaccinated against COVID-19 at least once (for the subcohort of vaccinated individuals)
• Existence of a declaration of consent

Exclusion Criteria

• Inability to give consent due to diseases that are not relevant to the study
• Inability to give consent and conflicting expressed or presumed will
• COVID-19 vaccination carried out (for the subcohort of not vaccinated individuals)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Characterization of differences in the clinical, immunological and virological course of the SARS-CoV-2 infection<br>b) Analysis of the causes of breakthrough infections<br>c) Identification of individual, immunological and genetic risk factors for inadequate COVID-19 vaccination protection or a more severe course of the disease<br>d) Surveillance of SARS-CoV-2 variants that lead to a vaccine escape or immune scape