COVID-19, Long COVID, Post COVID-19 Condition
Conditions
Keywords
Epidemiology, Pathophysiology, Prediction model, Patient platform
Brief summary
The CORFU study, funded by ZonMW, is a prospective, multiple, cohort study with a maximum follow-up of 24 months after COVID-19. Dutch COVID-19 patients from 7 existing prospective cohorts, aiming and designed to conduct COVID-19 research, will be included in this study. The CORFU study has 5 aims, divided into 4 work packages (WPs): 1. To describe the nature, severity, pattern and duration of long COVID complaints up to a maximum of two years after infection and its relationship with quality of life (WP1); 2. To describe the rehabilitation and corresponding activities for the treatment and improvement of complaints and quality of life (WP1); 3. To describe the pathophysiological processes that cause long COVID complaints, and the role of vulnerability/resilience factors (WP2); 4. To develop a prediction model for the persistence of complaints, with distinction between patients with and without pre-existing morbidity (WP3); 5. To develop a patient platform prototype in which patients can digitally consult their answers and compare their answers with reference populations (WP4, in collaboration with the EuroQol foundation). The 7 cohorts participating in the CORFU study are: POPCOrn, COVAS, ELVIS, MaastrICCht, DC&TC, CAPACITY-COVID, and Adelante cohort. (Clinical) baseline and follow-up data has been collected in these cohorts and will be used/aggregated to investigate CORFU study aims. In addition, questionnaires will be send to the (former) patients of the existing cohorts and patients will be asked about several domains such as persisting complaints and quality of life, at several moments, depending on when the patients have experienced COVID-19. Within this study a patient platform prototype will be developed, together with the EuroQol foundation, to be able to inform patients about the individual situation and course of disease.
Interventions
OTHERno intervention, the CORFU study conducts analyses based on data which has been prospectively collected (and aggregated when possible) in 7 existing cohorts
(Clinical) baseline and follow-up data will be collected in the 7 existing cohorts. These data will be aggregated (when possible). The CORFU analyses will be conducted based on the aggregated data.
Sponsors
Zuyderland Medical Centre
Leiden University Medical Center
UMC Utrecht
Radboud University Medical Center
Amsterdam University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All 7 existing cohorts have specific inclusion and
Exclusion criteria
. For the CORFU study, in general, the criteria are: Patients with proven or suspected COVID-19: * Confirmed (or suspected) COVID-19 - both home-isolated patients and patients who were admitted to the hospital ward and/or ICU; * Included in one of the seven cohorts from March 2020 onwards; * Aged 18 years or older; * Mastering the Dutch language sufficiently to answer the questionnaires; * Informed consent. Controls who did not experience COVID-19: * Aged 18 years or older; * Mastering the Dutch language sufficiently to answer the questionnaires; * Informed consent. There were no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of long COVID complaints (based on data from all 7 cohorts) | 24 months follow-up after COVID-19 | Long COVID complaints include: exhaustion, respiratory complaints, and mental health complaints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression (measured in all 7 cohorts) | 3, 6, 12, 18 and 24 months follow-up after COVID-19 | Measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores for both the Anxiety and Depression subscales range from 0 (best) to 21 (worst). A total subscale score of \>8 points indicates considerable symptoms of anxiety or depression. |
| Prevalence of thrombo-embolic complications (not measured in all 7 cohorts) | Measured during COVID-19 hospitalization (baseline), 3, 12, 24 months follow-up after COVID-19 | Thrombo-embolic complications of interest are: acute pulmonary embolism, deep-vein thrombosis, ischemic stroke, myocardial infarction and systemic arterial embolism The diagnosis, and therefore, the prevalence of various thrombo-embolic complications will be measured based on a combination of cardiovascular and thrombosis and haemostasis biomarkers (such as troponin I, CK-MB, APTT, and D-dimer), radiologic imaging techniques (computed tomography pulmonary angiography (CTPA), compression ultrasonography (CUS), echocardiography, CT scan of the brain, and CT angiography of the carotid and intracerebral arteries), and electrocardiogram. |
| Physical functioning (not measured in all 7 cohorts) | Measured during admission in the rehabilitation clinic (baseline), 3, 6, 12 months follow-up | Measured using the 6 minute walk test (6MWT). The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. The 6MWT result will be reported as a percentage of the predicted Dutch reference value which is based on the patient's age, sex, length and weight. A score \<82% of the predicted value is considered deviant. |
| (Health-related) Quality of life (measured in all 7 cohorts) | 3, 6, 12, 18 and 24 months follow-up after COVID-19 | Measured using the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaire. Based on the Dutch tariff, scores range between -0.446 (worst) and 1.000 (best). |
| Prevalence of endothelium dysfunction (not measured in all 7 cohorts) | Measured during COVID-19 hospitalization (baseline), 3, 12 months after COVID-19 | Measured using several biomarkers (such as endothelin-1, coagulation and inflammatory cytokines). |
| Disease severity during intensive care unit stay (not measured in all 7 cohorts) | Measured on the day of admission with COVID-19 to the intensive care unit (baseline), followed by daily measurement until discharge, an average of 18 days | Measured using the Sequential Organ Failure Assessment (SOFA) score which is based on the degree of dysfunction of six organ systems. For each organ system, scores range between 0 (best) to 4 (worst). A sum score per day at the intensive care unit can be calculated, which ranges between 0 (best) and 24 (worst). |
| Prevalence of cardiovascular diseases (not measured in all 7 cohorts) | Measured during COVID-19 hospitalization (baseline), 1 week, 1 month, and through study completion, an average of 2 years | Cardiovascular diseases of interest are: coronary artery disease, heart failure, myocardial fibrosis, myocarditis, pericarditis. The diagnosis, and therefore, the prevalence of various cardiovascular diseases will be measured based on a combination of radiologic imaging techniques (such as cardiac magnetic resonance, CT and echocardiography), cardial biomarkers (such as troponin and CK-MB), and electrocardiogram. |
Countries
Netherlands
Outcome results
None listed