Clinical trial NCT05240742: CORona (COVID-19) Follow Up Study: Epidemiology, Pathophysiology, Prediction, and Communication
Official title: Persistent Complaints After COVID-19: Epidemiology, Pathophysiology, Prediction, and Communication, the CORona Follow Up (CORFU) Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Long COVID
Post COVID-19 Condition
Keywords: Epidemiology
Pathophysiology
Prediction model
Patient platform
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Zuyderland Medical Centre
name: Leiden University Medical Center
name: UMC Utrecht
name: Radboud University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Adelante, Centre of Expertise in Rehabilitation and Audiology
First posted: 2022-02-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 exclusion criteria.

Primary outcomes:
measure: Prevalence of long COVID complaints (based on data from all 7 cohorts)
timeFrame: 24 months follow-up after COVID-19
Secondary outcomes:
measure: (Health-related) Quality of life (measured in all 7 cohorts)
timeFrame: 3, 6, 12, 18 and 24 months follow-up after COVID-19
measure: Anxiety and depression (measured in all 7 cohorts)
timeFrame: 3, 6, 12, 18 and 24 months follow-up after COVID-19
measure: Prevalence of thrombo-embolic complications (not measured in all 7 cohorts)
timeFrame: Measured during COVID-19 hospitalization (baseline), 3, 12, 24 months follow-up after COVID-19
measure: Physical functioning (not measured in all 7 cohorts)
timeFrame: Measured during admission in the rehabilitation clinic (baseline), 3, 6, 12 months follow-up
measure: Prevalence of cardiovascular diseases (not measured in all 7 cohorts)
timeFrame: Measured during COVID-19 hospitalization (baseline), 1 week, 1 month, and through study completion, an average of 2 years
measure: Prevalence of endothelium dysfunction (not measured in all 7 cohorts)
timeFrame: Measured during COVID-19 hospitalization (baseline), 3, 12 months after COVID-19
measure: Disease severity during intensive care unit stay (not measured in all 7 cohorts)
timeFrame: 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
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
Study officials:
affiliation: Maastricht University Medical Center
name: Sander MJ van Kuijk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Chahinda Ghossein-Doha, MD, PhD
role: STUDY_DIRECTOR
References:
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