Prospective sample collection, data collection and analysis for the clinical applicability of immunome profiles in the discrimination and therapy monitoring of COVID-19 patients in different disease stages as well as for the identification and characterization of long-term consequences of a SARS-CoV-2 infection in comparison to patients with a respiratory non-COVID-19 viral infectious disease and healthy controls.

Not Applicable

Not yet recruiting

• Conditions: U07.1; COVID-19, virus identified

• Registration Number: DRKS00024422
• Lead Sponsor: Fraunhofer ITMP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

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 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.