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

October 18, 2023 updated by: Maastricht University Medical Center

Persistent Complaints After COVID-19: Epidemiology, Pathophysiology, Prediction, and Communication, the CORona Follow Up (CORFU) Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229HX
        • Maastricht University Medical Center+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population consists of Dutch (former) COVID-19 patients and non-COVID-19 controls, who have been included in one of the cohorts and categorized in five 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).
  • Controls who did not suffer from (confirmed or suspected) COVID-19.

Description

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 exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dutch COVID-19 patients

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).
Other: no 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.
Other Names:
  • Integrated database
Dutch controls who did not experience COVID-19
One of the cohorts, the POPCOrn cohort, is a community-based cohort which partly consists of controls who did not experience COVID-19
Other: no 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.
Other Names:
  • Integrated database

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of long COVID complaints (based on data from all 7 cohorts)
Time Frame: 24 months follow-up after COVID-19
Long COVID complaints include: exhaustion, respiratory complaints, and mental health complaints.
24 months follow-up after COVID-19

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Health-related) Quality of life (measured in all 7 cohorts)
Time Frame: 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).
3, 6, 12, 18 and 24 months follow-up after COVID-19
Anxiety and depression (measured in all 7 cohorts)
Time Frame: 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.
3, 6, 12, 18 and 24 months follow-up after COVID-19
Prevalence of thrombo-embolic complications (not measured in all 7 cohorts)
Time Frame: 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.
Measured during COVID-19 hospitalization (baseline), 3, 12, 24 months follow-up after COVID-19
Physical functioning (not measured in all 7 cohorts)
Time Frame: 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.
Measured during admission in the rehabilitation clinic (baseline), 3, 6, 12 months follow-up
Prevalence of cardiovascular diseases (not measured in all 7 cohorts)
Time Frame: 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.
Measured during COVID-19 hospitalization (baseline), 1 week, 1 month, and through study completion, an average of 2 years
Prevalence of endothelium dysfunction (not measured in all 7 cohorts)
Time Frame: Measured during COVID-19 hospitalization (baseline), 3, 12 months after COVID-19
Measured using several biomarkers (such as endothelin-1, coagulation and inflammatory cytokines).
Measured during COVID-19 hospitalization (baseline), 3, 12 months after COVID-19
Disease severity during intensive care unit stay (not measured in all 7 cohorts)
Time Frame: 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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Radboud University Medical Center
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leiden University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
Zuyderland Medical Centre

Investigators

  • Principal Investigator: Sander MJ van Kuijk, PhD, Maastricht University Medical Center
  • Study Director: Chahinda Ghossein-Doha, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC2021-2990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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