U09.9
Conditions
Interventions
Group 1: This is a prospective observational trial involving patients with diagnosis of post-covid. A large number of participants has already taken part in the clinical trial "PreVitaCOV".
Each part
Sponsors
Institut für Allgemeinmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: There must be proof of SARS-CoV-2 infection after which post-COVID symptoms began. This must be provided before the end of February 2024 either a) by a PCR test or antibody test (nucleocapsid antibodies), or b) confirmed by the clinical assessment of the general practitioner in conjunction with a positive rapid test, regardless of where this was carried out. Furthermore, at least one of the following post-COVID symptoms, such as fatigue, dyspnea, cognitive problems, anxiety and/or depressiveness, must have been present for at least 12 weeks. The post-COVID symptoms must be persistent until study inclusion and must have developed during or after infection with SARS-CoV-2. Complete documentation must be provided by the general practitioner (confirmation of post-COVID diagnosis, proof of SARS-CoV-2 infection, data on previous illnesses and medication).
Exclusion criteria
Exclusion criteria: Participants must not have been treated in an intensive care unit for a COVID-19 disease. There must be no other cause of the symptoms, such as chronic fatigue, tumor disease, sleep apnea, severe anemia or preexisting/prior depression. This only includes depression disorders that are currently being treated with medication and have required treatment in the last 5 years before COVID-19. Conditions that have not required treatment for at least 5 years (before the post-COVID disease) are not an exclusion criterion. Also, this does not include exclusively psychotherapeutically treated or untreated illnesses and single depressive episodes. There must be no inability to give consent, no insufficient language skills, and no inability to visit the study center. Additionally, participants will be excluded if they had already applied for or received a care level of at least II before the post-COVID-19 illness or are currently living in a nursing home. This does not include participants in assistend living facilities without nursing care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety, depression, cognitive function, fatigue, activities of daily living, pain measured by the Patient Reported Outcome Measurement Information System (PROMIS) A-F. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive status: Montreal Cognitive Assessment (MoCA); Various aspects of attention: Test battery for attention testing (TAP); Physical fitness: 1-minute sit-to-stand test, handgrip strength measurement; Orthostatic dysregulation: NASA lean test; Subjective pain perception: Numerical Rating Scale (NRS); Subjective complaints: Measure Yourself Medical Outcome Profile (MYMOP2-G); Post-COVID functional impairment: Post-COVID-19 Functional Status Scale (PCFS); Post-COVID-19 Symptom List, Canadian Consensus Criteria for the Diagnosis of ME/CFS (CCC), Screening for Post-Exertional Malaise (DSQ-PEM), Health-related quality of life: EQ-5D-5L, Visual Analog Scale (VAS); Depressive symptoms: Patient Health Questionnaire (PHQ-8); Anxiety Symptoms: Generalized Anxiety Disorder (GAD-7); Fatigue: Chalder Fatigue Scale (CFQ); Resilience: Brief Resilience Scale (BRS). In addition, vital parameters (body height and weight, heart and respiratory rate, blood pressure, oxygen saturation, temperature) and laboratory parameters (complete blood count, glutamate-oxaloacetate transaminase (GOT/ASAT), glutamate-pyruvate transaminase (GPT/ALAT), gamma-glutamyltransferase (gamma-GT), creatinine, glomerular filtration rate (GFR), sodium, potassium, calcium, C-reactive protein (CRP), thyroid stimulating hormone (TSH) and cytokines) , socio-demographic data as well as information on the occupational situation, SARS-CoV-2 infection and vaccinations, concomitant diseases and medication, previous medical history and the history of the disease. | — |
Countries
Germany
Contacts
Public ContactSabine Sellmann
Institut für Allgemeinmedizin
Outcome results
None listed