Trial for collection of blood samples from healed Covid-19 patients - research and development of in-vitro diagnostics
- Conditions
- SARS-CoV-2 infectionCovid-19U07.1COVID-19, virus identified
- Registration Number
- DRKS00022406
- Lead Sponsor
- R-Biopharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Ability to understand and sign the informed consent form
2. Women and men above 18 years old
3. Earlier Covid-19 disease, confirmed by a positiv PCR result
Exclusion Criteria
4. Any event which in the opinion of the invesigator prevents the participation of this patient in the study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The purpose of the study is the collection of paired blood samples (5ml serum and 5 ml plasma) from up to 50 adults convalesced and healed from Covid-19 on the investigator site Borstel witin 4-6 weeks. The blood samples will be used from R-Biopharm AG in cooperation with the affiliated company Seramun Diagnostica GmbH for the development of a SARS-CoV-2 antibody test for the qualitative detection of human anti-SARS-CoV-2-IgG antibodies. The product should detect analytes from serum and plasma (citrate, heparine, EDTA). Therefore, the matrix equivalence witin the test development should be prooved. The collected samples will be used for this purpose.
- Secondary Outcome Measures
Name Time Method The secondary outcome of the study is the characterisation of paired samples with the use of a Case Report Form.