Evaluation of SARS-CoV2-specific serum parameters in blood samples of SARS-CoV2-seronegative healthy volunteers, hospitalized SARS-CoV2-patients with acute disease and recovered SARS-CoV2-patients with asymptomatic/mild/severe disease.
Not Applicable
- Conditions
- U07.1COVID-19, virus identified
- Registration Number
- DRKS00023877
- Lead Sponsor
- Heidelberg ImmunoTherapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
1. Signed informed consent.
2. At least one positive SARS-CoV-2 swab/PCR-test (groups b-e).
3. Availability of data (e.g. discharge letters) to assign the patient in one of the groups (asymptomatic/mild/severe) and to document the course of the COVID-19-disease.
4. Subject/patient is at least 18 years old and able to give informed consent.
Exclusion Criteria
1. Every disease or status that does not allow the blood drawing according to the assessment of the consenting physician.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This trial does not fall under the German drug or device law as no drug is applied; only one blood drawing takes place.<br>The aim of this trial is to compare SARS-CoV-2-specific serum parameters (e.g. IgG-, IgA-, IgM-level, lipids etc.) of different populations (SARS-CoV-2-seronegative subjects, patients with acute COVID-19 disease as well as of recovered SARS-CoV-2-patients with asymptomatic/mild/severe disease).<br>This trial is designed to establish assays that can be used in the future to clinical trials with patients suffering from COVID-19. The results of this trial might also be used in drug development projects.
- Secondary Outcome Measures
Name Time Method