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Identification of characteristic biological factors of a Post-COVID 19-syndrome

Identification of characteristic biological factors of a Post-COVID 19-syndrome - PRAM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031728
Enrollment
75
Registered
2023-05-15
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-COVID-syndrome, ME/CFS U09 G93.3

Interventions

Group 1: Analysis of a single sample of respiratory condensate (non-targeted metabolome analysis), as well as of urine and optionally of blood from each of 25 women suffering from a Post-COVID-Syndrom

Sponsors

Universitätsklinik Freiburg, Molekulare Präventivmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Medically diagnosed Post-COVID-syndrome with strong fatigue symptoms including a exercise-dependent worsening of symptoms (N=25) - Or medically diagnosed ME/CFS, not caused by a Sars-CoV-2 infection or by a Post-Vac-syndrome (N=25) - Or healthy women without any fatigue symptoms, nor a known nutrient deficiency nor an acute or chronic physical or mental disease (N=25)

Exclusion criteria

Exclusion criteria: - Active nicotine consumption for the last 5 years - People under legal supervision - Pregnancy or breastfeeding period - Fatigue caused by chronic somatic primary desease, e.g. Multiple sclerosis, tumor disease, myasthenia, narcolepsy, chronic anemia - Post-Vac-syndrom - Severe depression (BDI Score = 29)

Design outcomes

Primary

MeasureTime frame
Metabolome analysis of the respiratory condensate samples. By means of WEIMuS-Questionnaire the fatigue´s severity will be determined and set in correlation with the results of the non-targeted metabolome analysis.

Secondary

MeasureTime frame
Analysis of urine samples with regard to the following parameters: - Endogenous substances: Neurotransmitters (cortisol, catecholamines, serotonin, gamma-aminobutyric acid and their metabolites) and markers of oxidative stress such as dityrosine, F2-isoprostanes, allantoin, hemopyrrole, as well as urinary metabolomics; leaky gut markers (zonulin, occludin, LPS-binding protein, soluble CD14, intestinal fatty acid-binding protein, LPS, EndoCAb IgG, EndoCAb IgM, EndoCAb IgA), as well as S100B and trimethylamine N-oxide (TMAO) in plasma - Exogenous substances: Environmental chemicals, including per- and polyfluoroalkyl substances (PFAS) and bisphenols in urine and plasma - Bacterial vesicles in urine Also magnesium, zinc, Vitamin B12, secondary bile acids as well as per-and polyflourinated alcyl compounds and bisphenoles will be determined in the optionally given blood samples.

Countries

Germany

Contacts

Public ContactSilke Frey

Universität Augsburg, Medizinische Fakultät, Lehrstuhl Erforschung umweltbezogener Wirkmechanismen auf die Gesundheit

silke.frey@med.uni-augsburg.de+49 (0) 821 598 6448

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026