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

COVID-19 Clinical Trial

— CORFU  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05240742
• Other study ID #: METC2021-2990
• Status: Enrolling by invitation
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

Bels JLM, van Kuijk SMJ, Ghossein-Doha C, Tijssen FH, van Gassel RJJ, Tas J, Collaborators M, Schnabel RM, Aries MJH, van de Poll MCG, Bergmans DCJJ, Meex SJR, van Mook WNKA, van der Horst ICC, van Bussel BCT. Decreased serial scores of severe organ failure assessments are associated with survival in mechanically ventilated patients; the prospective Maastricht Intensive Care COVID cohort. J Crit Care. 2021 Apr;62:38-45. doi: 10.1016/j.jcrc.2020.11.006. Epub 2020 Nov 17. — View Citation

Dutch COVID & Thrombosis Coalition (DCTC). Early effects of unfractionated heparin on clinical and radiological signs and D-dimer levels in patients with COVID-19 associated pulmonary embolism: An observational cohort study. Thromb Res. 2021 Apr;200:130-132. doi: 10.1016/j.thromres.2021.01.023. Epub 2021 Feb 2. No abstract available. — View Citation

Dutch COVID & Thrombosis Coalition; Kaptein FHJ, Stals MAM, Grootenboers M, Braken SJE, Burggraaf JLI, van Bussel BCT, Cannegieter SC, Ten Cate H, Endeman H, Gommers DAMPJ, van Guldener C, de Jonge E, Juffermans NP, Kant KM, Kevenaar ME, Koster S, Kroft LJM, Kruip MJHA, Leentjens J, Marechal C, Soei YL, Tjepkema L, Visser C, Klok FA, Huisman MV. Incidence of thrombotic complications and overall survival in hospitalized patients with COVID-19 in the second and first wave. Thromb Res. 2021 Mar;199:143-148. doi: 10.1016/j.thromres.2020.12.019. Epub 2020 Dec 30. — View Citation

Kruip MJHA, Cannegieter SC, Ten Cate H, van Gorp ECM, Juffermans NP, Klok FA, Maas C, Vonk-Noordegraaf A; Dutch COVID Thrombosis Coalition study group. Caging the dragon: Research approach to COVID-19-related thrombosis. Res Pract Thromb Haemost. 2021 Mar 8;5(2):278-290. doi: 10.1002/rth2.12470. eCollection 2021 Feb. — View Citation

Leijte WT, Wagemaker NMM, van Kraaij TDA, de Kruif MD, Mostard GJM, Leers MPG, Mostard RLM, Buijs J, van Twist DJL. [Mortality and re-admission after hospitalization with COVID-19]. Ned Tijdschr Geneeskd. 2020 Nov 19;164:D5423. Dutch. — View Citation

Long D, Haagsma JA, Janssen MF, Yfantopoulos JN, Lubetkin EI, Bonsel GJ. Health-related quality of life and mental well-being of healthy and diseased persons in 8 countries: Does stringency of government response against early COVID-19 matter? SSM Popul Health. 2021 Sep 1;15:100913. doi: 10.1016/j.ssmph.2021.100913. eCollection 2021 Sep. — View Citation

Tas J, van Gassel RJJ, Heines SJH, Mulder MMG, Heijnen NFL, Acampo-de Jong MJ, Bels JLM, Bennis FC, Koelmann M, Groven RVM, Donkers MA, van Rosmalen F, Hermans BJM, Meex SJ, Mingels A, Bekers O, Savelkoul P, Oude Lashof AML, Wildberger J, Tijssen FH, Buhre W, Sels JEM, Ghossein-Doha C, Driessen RGH, Kubben PL, Janssen MLF, Nicolaes GAF, Strauch U, Geyik Z, Delnoij TSR, Walraven KHM, Stehouwer CD, Verbunt JAMCF, Van Mook WNKA, van Santen S, Schnabel RM, Aries MJH, van de Poll MCG, Bergmans D, van der Horst ICC, van Kuijk S, van Bussel BCT. Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht). BMJ Open. 2020 Sep 29;10(9):e040175. doi: 10.1136/bmjopen-2020-040175. — View Citation

van Gassel RJJ, Bels JLM, Raafs A, van Bussel BCT, van de Poll MCG, Simons SO, van der Meer LWL, Gietema HA, Posthuma R, van Santen S. High Prevalence of Pulmonary Sequelae at 3 Months after Hospital Discharge in Mechanically Ventilated Survivors of COVID-19. Am J Respir Crit Care Med. 2021 Feb 1;203(3):371-374. doi: 10.1164/rccm.202010-3823LE. No abstract available. — View Citation

Wiertz CMH, Vints WAJ, Maas GJCM, Rasquin SMC, van Horn YY, Dremmen MPM, Hemmen B, Verbunt JA. COVID-19: Patient Characteristics in the First Phase of Postintensive Care Rehabilitation. Arch Rehabil Res Clin Transl. 2021 Jun;3(2):100108. doi: 10.1016/j.arrct.2021.100108. Epub 2021 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of long COVID complaints (based on data from all 7 cohorts)	Long COVID complaints include: exhaustion, respiratory complaints, and mental health complaints.	24 months follow-up after COVID-19
Secondary	(Health-related) Quality of life (measured in all 7 cohorts)	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
Secondary	Anxiety and depression (measured in all 7 cohorts)	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
Secondary	Prevalence of thrombo-embolic complications (not measured in all 7 cohorts)	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
Secondary	Physical functioning (not measured in all 7 cohorts)	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
Secondary	Prevalence of cardiovascular diseases (not measured in all 7 cohorts)	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
Secondary	Prevalence of endothelium dysfunction (not measured in all 7 cohorts)	Measured using several biomarkers (such as endothelin-1, coagulation and inflammatory cytokines).	Measured during COVID-19 hospitalization (baseline), 3, 12 months after COVID-19
Secondary	Disease severity during intensive care unit stay (not measured in all 7 cohorts)	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

External Links

•   CAPACITY COVID-19: Registry of patients with COVID-19 including cardiovascular risk and complications