U07.1
Conditions
Interventions
Group 1: Hospitalized COVID-19 patients (main diagnosis), Blood sample, nasopharyngeal swap, questionnaire , information from the medical record, interview 2,6,12,18,24 months after hospital discharge
Sponsors
Robert Koch-Institut
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Members of a population group that is prioritized to receive a COVID-19 vaccination at the time of recruitment SARS-CoV-2 detection by PCR with respiratory sample materials AND COVID-19 as a main diagnosis leading to hospitalisation or a primary diagnosis that is a plausible COVID-19 complication (e.g. heart attack, stroke) or nosocomial COVID-19 and the disease is severe that hospitalization would have been required for treatment even without the primary diagnosis Controls: Members of a population group prioritized to receive a COVID-19 vaccination at the time of recruitment AND SARS-CoV-2 negative AND with a diagnosis of acute surgical, urological, gynecological, traumatological or orthopedic diseases that should neither have an influence on the probability of being vaccinated against COVID-19 nor on the probability of developing COVID-19
Exclusion criteria
Exclusion criteria: Cases / controls: Indiviuals who • cannot give their informed consent to the study, unless the consent of a legal representative can be obtained • who are not eligible for vaccination due to a life-threatening contraindication, e.g. history of an anaphylactic reaction to vaccine components. • who, according to the STIKO recommendations, belong to a population group in which no or very few people are vaccinated at the time of recruitment. For the follow-up interviews after discharge: controls that have been infected with SARS COV-2 are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COVID-19 efficacy and safety. Prevention of severe COVID-19 requiring hospitalization (primary endpoint) with COVID-19 vaccines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimation of vaccine specific effectiveness, vaccine effectiveness in risk groups, vaccine effectiveness against SARS-CoV-2 variants, duration of vaccine protection, comparison of disease severity in vaccinated and unvaccinated COVID-19 cases (including long term health condition ("post COVID symptoms" up to 24 month) , immunoligical investigations to rule out disease enhancing antibodies due to vaccination (ADE/VAERD) | — |
Countries
Germany
Contacts
Public ContactAnna Stoliaroff
Robert Koch-Institut, Abteilung für Infektionsepidemiologie, FG 33 Impfprävention
Outcome results
None listed