Study design
infections, pain
RECRUITMENT, INFECTIONS
Recruitment of participants and sample collection were conducted at five study sites in North Rhine-Westphalia, Germany (University Hospital of Cologne, University Hospital of Düsseldorf, University Hospital of Essen, University Hospital of Bonn, and University Hospital of Münster). Participation was offered to patients receiving medical treatment in emergency departments at one of the five study sites between August 8, 2022 and September 19, 2022. The study personnel recruited 1411 participants in cooperation with the emergency department personnel. Patients were required to meet the following eligibility criteria in order to be enrolled as participants: (i) only individuals aged ≥18 years were eligible, (ii) participants had to be patients at the emergency department at one of the five study sites, (iii) patients had to be able to consent to participate, (iv) the ability to consent was furthermore checked by the study personnel with a special focus on the medication, pain and the exceptional emotional situation of the patients, and (v) according to the assessment of the study personnel, participation in the study should not be a significant additional burden for the patients. After verification of eligibility criteria and obtaining written informed consent by the study physicians, during blood collection, which was part of the standard medical treatment at the emergency departments, up to an additional 20 mL of blood was drawn from the participants to be analyzed in this study. Information on epidemiological data (age, sex, nationality, place of residence) and clinical data (body length and weight, pre-existing conditions, immunosuppressive medication), as well as information on COVID-19 vaccination status (number of shots received, received vaccine type, date of vaccination), and past infections with SARS-CoV-2 (date of positive RT-qPCRs and/or rapid antigen detection tests) was verbally requested by the study personnel or extracted from the medical records of the participants. Samples and data collected at one study site were pseudonymized at that site and analyzed centrally at the study site in Cologne. In addition, serum samples obtained at each study site were analyzed at that site to assess assay validity, as described further in “Methods Details”.