CORona (COVID-19) Follow Up Study: Epidemiology, Pathophysiology, Prediction, and Communication

• Conditions: COVID-19; Post COVID-19 Condition; Long COVID
• Interventions: Other: no intervention, the CORFU study conducts analyses based on data which has been prospectively collected (and aggregated when possible) in 7 existing cohorts

• Registration Number: NCT05240742
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dutch controls who did not experience COVID-19	no intervention, the CORFU study conducts analyses based on data which has been prospectively collected (and aggregated when possible) in 7 existing cohorts	One of the cohorts, the POPCOrn cohort, is a community-based cohort which partly consists of controls who did not experience COVID-19
Dutch COVID-19 patients	no intervention, the CORFU study conducts analyses based on data which has been prospectively collected (and aggregated when possible) in 7 existing cohorts	The study population consists of Dutch (former) COVID-19 patients who have been included in one of the cohorts and categorized in various subgroups: * Patients who suffered from (confirmed) COVID-19 and were admitted to the hospital ward. * Patient who suffered from (confirmed) COVID-19 and were admitted to the ICU. * Patients who suffered from (confirmed or suspected) COVID-19 at home. * Patients who suffered from (confirmed) COVID-19 and were in need of inpatient or outpatient rehabilitation after infection at home or in the hospital (ward and/or ICU).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).
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.
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.
(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).
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).

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Netherlands