Evaluation of SARS-CoV2-specific serum parameters in blood samples of hospitalized COVID-19 patients with acute disease and recovered COVID-19 patients with asymptomatic disease (HTXCOV-01K)
Not Applicable
- Conditions
- 07.1
- Registration Number
- DRKS00028158
- Lead Sponsor
- Heidelberg ImmunoTherapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
1. Existence of consent to participate in the study.
2. The patient is at least 18 years old and capable of giving consent. In the case of patients of legal age who are unable to give their consent, consent can be given by a legal guardian.
3. Detection of at least one-time positive SARS-CoV-2 swab PCR test or antibody test for COVID-19.
4. Acute hospitalized due to COVID-19 pneumonia OR recovered with an asymptomatic course.
5. After prior consultation with the sponsor, patients who have received at least one vaccination against the SARS-CoV-2 virus may also be included.
Exclusion Criteria
1. Any illness or condition that does not medically permit the blood sample in the opinion 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. 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 (patients with acute COVID-19 disease as well as recovered SARS-CoV-2-patients with asymptomatic disease). This trial is designed to establish assays that can be used in the future to plan 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