SARS-CoV-2 infection Covid-19 U07.1
Conditions
Interventions
Group 1: A serum sample as well as a plasma sample will be collected from all participants.
Sponsors
R-Biopharm AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 4. Any event which in the opinion of the invesigator prevents the participation of this patient in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary outcome of the study is the characterisation of paired samples with the use of a Case Report Form. | — |
Countries
Germany
Contacts
Public ContactJan Heyckendorf
Klinisches StudienzentrumForschungszentrum BorstelLeibniz Lungenzentrum/Medizinische Klinik
Outcome results
None listed