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Identification of Characteristic Biological Factors of a Post-COVID-19 Syndrome (PRAM)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2023-05-31
Completion (planned):
2024-05-30
Last update:
2023-12-18

 

Research types:
Epidemiological research
Research areas:
General
Interventions:
Not applicable
Priv. Sector Partner:
Not available
Sponsors:

Project description

Since the worldwide spreading of SARS-CoV-2, several studies have shown that minimum 10% of all people who has infected with SARS-CoV-2 suffer from long-term consequences. This so-called post-COVID syndrome (PCS) describes a complex of symptoms persisting for minimum 12 weeks after an acute infection with SARS-CoV-2, which may affect 10 organ systems and cause up to 200 symptoms in different duration and combination. Above all fatigue-symptoms in different manners stand out. Furthermore it is noticeable that girls and women are affected by a PCS much more often than boys and men.

There is some evidence that chronic inflammatory mechanisms, vascular occlusions, autoimmune processes and others have an impact on fatigue pathogenesis. Nevertheless etiology and pathophysiology in detail are still unknown. Therefore no adequate diagnostics, prognosis nor therapy can be offered to the patients yet. A possibly relevant fact could be that the symptoms of a PCS are not only very similar to the ones of ME/CFS but half of the post-COVID patients even fulfill the diagnostic criteria for ME/CFS after 6 months of illness duration. The pathomechanism of ME/CFS is also still unknown.

For this purpose we set up a 3-arm case-control-study with 75 female volunteers, 25 of them suffering from PCS, another 25 are diagnosed with ME/CFS and 25 healthy women. The aim of the study is to explore biological factors which may be pathophysiologically relevant for a typical fatigue, more specifically a PCS. By means of non-targeted liquid chromatography with mass-spectrometry coupling (LC/MS) the metabolom of respiratory condensate of all participants will be analysed, compared with each of the study groups and set in correlation with fatigue severity. Severity of fatigue symptoms is determined by WEIMuS-Questionnaire. Additionally, all urine samples will be examined for predefined endogenous and exogenous substances partly showing adverse immunoregulatory effects, as well as for extracellular bacterial vesicles.

Besides that, in the optionally given blood samples intracellular magnesium, zinc, vitamin B12, secondary bile acids and exogenous substances will be determined.

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

Patient cohort

Post-COVID Syndrome (PCS) with Post-Exertional Malaise (PEM) as well as non-COVID ME/CFS compared with healthy controls. All female.

Patients enrolled: 75

Age group: 18 - 65 years (Older Adults, Adults)

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People (3)
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