Beyond COVID - characterization of health and psychosocial long-term effects after convalescence of a SARS-CoV-2 infection (COVID-19) in North Rhine-Westphalia

Recruiting

Conditions: U09.9
U08.9
Post COVID-19 condition, unspecified
Personal history of COVID-19, unspecified

Registration Number: DRKS00027377

Lead Sponsor: niversitätsklinikum Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

Main residence in North Rhine-Westphalia in the area of the cities of Aachen, Bonn, Düsseldorf, Essen, Cologne or Münster
- 18 - 75 years old
- Proof of a survived SARS-CoV-2 infection (PCR-test)
- Infection in the period from March 1st, 2021 (1st recruitment round)
- the time of infection is at least 3 months back (inpatients: date of the COVID-19-related inpatient admission day; outpatients: date of the first positive PCR test)
- The person is able to take part in the survey and the examinations
- sufficient knowledge of the German language or support from an interpreter

Exclusion Criteria

- Active SARS-CoV-2 infection and / or time of infection is less than 3 months back (inpatients: Date of admission; outpatients: date of the first positive PCR-test). Inclusion possible at a later date.
- Lack of diagnostic evidence of SARS-CoV-2 infection using a PCR test
- Person is unable to give written informed consent
- Other reasons that study participants can not visit the study center, e.g. due to logistical reasons.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Evaluate long term cardial, lung and liver function (abdominal sonography, echocardiocraphy, pulmonary function examination, blood tests)<br>-Changes in Quality of Life, physically and mental health, functioning and activity an public health aspects (multiple validated questionnaires)<br>-medical resource use (questionnaire)<br>-cognitive/neurological impairment (neuropsychological assessment)<br>Time schedule: At 3, 6, 12, 18, 24, 30 and 36 month after SARS-CoV-2-Infection

Secondary Outcome Measures

Name	Time	Method
-Patient characteristics and differences in those with/without Long-Covid complications (blood tests, genetic analysis, humoral and cellular immunity directed against SARS-CoV-2; immunological factors responsible for the observed long-term effects)<br>-Definition and characteristics of the early and late COVID-19 complications<br>-Evaluation of Long-Covid depending on the severity of the course of COVID-19 and comorbidities<br>Time schedule: At 3, 6, 12, 18, 24, 30 and 36 month after SARS-CoV-2-Infection