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Health Care Workers Affected by Long COVID and Exhaustion/Fatigue (HALE Study)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2022-07-03
Completion (planned):
Not available
Last update:
2023-11-30

 

Research types:
Epidemiological research
Research areas:
General
Interventions:
Hand grip strength (HGS) test, Active standing test, Cognitive function test
Priv. Sector Partner:
Not available
Sponsors:

Project description

The HALE study deals with a group of hospital employees with persistent symptoms, especially fatigue, after a SARS-CoV-2 infection. Previously, these employees stood out during follow-up surveys (June-October 2021) with persistent symptoms after their infections, which could be caused by a long COVID disease. Long COVID is defined as new onset, worsening, or persistent symptoms four weeks after SARS-CoV-2 infection.

The study will initially include all employees who tested positive for SARS-CoV-2 by PCR test between March 2020 and May 2021 and reported the persitent symptom "fatigue" at the time of the follow-up interview (arm 1). Participants from arm 1 will take part in a qualitative interview with the help of a developed questionnaire, which focuses on existing symptoms in particular. In addition, questionnaires are used to apply the diagnostic Canadian Consensus Criteria for ME/CFS, classification with the Bell score and screening for post-exertional malaise (PEM). Furthermore, the Montreal Cognitive Assessment (MoCA), a hand strength measurement and an orthostasis test are performed. Additionally the participants have the option to wear fitness tracker device. A further history of symptoms and physical examination will be performed by the occupational medicine department. Furthermore, the study includes a current SARS-CoV-2 PCR test, general blood work, and a detailed blood coagulation analysis. Subsequently, the subjects can be examined by other specialities of Kliniken der Stadt Köln or cooperating hospitals.

The diagnostic criteria will be supported by examinations of the employees and possible other causes will be excluded. In addition to diagnostic criteria, the symptoms and respective side effects occurring in each case, after SARS-CoV-2 infection, will be presented. The aim of the study is to determine to what extent the diagnostic criteria of ME/CFS can also be applied to long-COVID patients.

A control group (arm 2) will contribute to the evaluation of hand strength measurements in arm 1 of the study. The participants of the control group participate in a qualitative interview with help of a developed questionnaire. Moreover, questionnaires are used to apply the diagnostic Canadian Consensus Criteria for ME/CFS, classification with the Bell score and screening for post-exertional malaise (PEM). This is followed by a hand strength measurement and general blood work.

(Description adapted from clinical trial website: see link above)

Patient cohort

Post-COVID Syndrome (PCS) according to WHO, including ME/CFS according to Canadian Consensus Criteria (CCC). Comparisson with healthy controls.

Patients enrolled: 19

Age group: Not available

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