U07.1
Conditions
Interventions
Group 1: COVID-19-patients (Group 1): WHO score 5-7 (severe - very severe)
Depending on the duration of the inpatient treatment (current average around 14 days), maximum drawing of 7 samples every 2
Sponsors
Fraunhofer ITMP
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for COVID-19 patients: • positive testing for SARS-CoV-2 (PCR) or first presentation to the hospital if the test is known to be positive • Written consent to participate in the study by the patient or, in the case of patients unable to consent, by the legal representative • Moderate or severe COVID-19 illness according to the WHO classification scheme: o Patient group 1: Score 5-7 (severe - very severe) o Patient group 2: Score 3 or 4 (moderate - moderate-severe) Inclusion criteria for patients with respiratory non-COVID-19 viral infectious disease: • positive test for a respiratory non-SARS-CoV-2 virus infection or first presentation in hospital if the test is known to be positive • negative test for SARS-CoV-2 within the last 2 weeks • Willingness and ability to give consent to participate in the study and clinical examinations and to adhere to the requirements of the study plan • Moderate to moderately severe respiratory non-COVID-19 viral infectious disease according to the WHO classification scheme: o Control group A: Score 3 or 4 (moderate - moderate-severe)
Exclusion criteria
Exclusion criteria: Exclusion criteria for COVID-19 patients: • Imprisoned or incapacitated patients • Severe anemia (Hb <8mg / dl), which does not allow drawing blood regularly Exclusion criteria for patients with a respiratory non-COVID-19 viral infectious disease: • Imprisoned or incapacitated patients • Severe anemia (Hb <8mg / dl), which does not allow drawing blood regularly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in the function of organ systems (breathing, cardiovascular or digestive system) form our predictable endpoints. In this specific case, these are the changes of immunome profile: 1. the lipidome, 2. the metabolome and 3. the proteome in the patients blood in relation to the clinical disease activity, clinical infestation pattern, concomitant diseases and length of disease as well as the comparison to immunome profiles of the control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Generation of an immunome profile composed of additional analyses: o DNA and RNA sequencing and profiling of specific cell populations from the blood; epigenetic analyses o additional studies (flow cytometry) of various immune-relevant cell populations and markers in the blood and urine o microbiome analysis • Clinical disease activity and quality of life (EQ-5D-questionnaire) • Comparison of immunome profiles in individual patients with regard to measurement at different times points, for example: o at different degrees of activity of the disease o during constant therapy o in case of a therapy adjustment o regarding comorbidities • Comparison of immunome profiles between patient groups depending on the degree of disease activity, length and quality of life as well as in relation to control groups • Detection of overlaps and transitions within immunome profiles • Recording of the course of the disease: o Change in severity according to WHO guidelines o patient groups classification o number of patients who exhibit changes in disease severity during the study o number of patients with consistent WHO scores o sequence and reversibility of symptoms o number of patients recovering o time to recovery | — |
Countries
Germany
Contacts
Public ContactEduard Resch
Fraunhofer ITMP
Outcome results
None listed