U09.9 U08.9 G93.3 G47 R06.0 F06.7 R43 R51
Conditions
Interventions
Group 1: No intervention/randomization design ? single-arm, prospective longitudinal observational study.
Group A – PROM/PREM longitudinal cohort (multicenter, non-interventional)
Adults with post-COV
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written declaration of consent After consent/initial consultation with adult patients: Symptoms consistent with post-COVID or post-VAC syndrome that occur after a new, highly probable or confirmed SARS-CoV-2 infection* or proven COVID-19 vaccination, begin three months after this infection or vaccination, persist for at least 12 weeks, and cannot be explained by any other medical cause [1]. *The SARS-CoV-2 infection must be defined by one of the following tests/constellations: o Detection of SARS-CoV-2 infection by polymerase chain reaction (PCR) o Detection of SARS-CoV-2 infection by rapid antigen test (AST) in the context of plausible COVID-19 symptoms. o A SARS-CoV-2 infection that is considered probable/confirmed but has not been detected using the above-mentioned test procedures o * In the context of neurocognitive testing, detection by means of a PCR or an AST is required
Exclusion criteria
Exclusion criteria: Insufficient knowledge of the German language to complete the questionnaires Patients with current psychotic symptoms, substance dependence or abuse, and organic brain disorders. Pre-existing cardiovascular disease (e.g., heart failure, cardiac arrhythmia, coronary heart disease) Pre-existing organic brain/neurodegenerative diseases Pre-existing chronic inflammatory/autoimmune diseases Pre-existing pulmonary disease Active tumor disease or tumor disease in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue (FSMC) Post-exertional malaise (DSQ-PEM) Post-COVID symptom score (PCS) Sleep (ISI), depression (PHQ-9), anxiety (GAD-7) Somatic stress (SSS-8, SSD-12) Functional status (PCFS), quality of life (EQ-5D-5L) Pain (PDI) Subjective cognitive impairments (all at T0–T3, assessed identically in all centers) | — |
Secondary
| Measure | Time frame |
|---|---|
| PREMs: Patient satisfaction ZUF-8 (T1–T3). Neuropsychological findings (T0, T1, T2): Digit Span (WMS-R), Regensburg Word Fluency Test (RWT), SDMT, VLMT. Clinical functional tests (T0): 1-minute sit-to-stand (1MSTS), hand grip strength (dynamometer). Additional module (Erlangen only, T0–T3): Personality (Big Five), overcommitment/ERI, coping with illness (PUK-2 adapted), WHO-QOL, Optimism (SOP-2), Work Ability Index (WAI), Self-Efficacy (AS-KU), Achievement Motivation Scale (AMS_10), Personality Structure (LPFS-BF 2.0), Emotional Processing (LEAS). | — |
Countries
Germany
Contacts
Public ContactEva Morawa
Universitätsklinikum Erlangen
Outcome results
None listed