Post COVID U09.9
Conditions
Interventions
Group 1: 3g creatine monohydrate (CreaVitalis TM) for at least 10 to a maximum of 14 weeks (orally)
Group 2: 3g maltodextrin (placebo)
Sponsors
Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Outpatient post-COVID patients between 20-60 years (female and male), past SARS-CoV-2 infection (detected with positive PCR, at least 12 weeks ago), outpatient course of COVID-19 (WHO severity <4), persistent symptoms with Fatigue Assessment Scale = 22.
Exclusion criteria
Exclusion criteria: Pregnancy/breastfeeding, lack of German, reading and/or writing skills, inability to consent, Any concomitant illness that, according to a doctor’s assessment, speaks against participation in the study (especially chronic inflammatory diseases, previous neurological diseases, unmedicated internal diseases, chronic or acute kidney diseases). Taking other sports supplements (protein shakes, etc.) during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6-min walk test after 10 weeks compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hand strength at 10 weeks compared to baseline. Change in Timed Up&Go test after 10 weeks compared to baseline. Change in the 10-minute leaning test after 10 weeks compared to baseline. Change in the Montreal Cognitive Assessment Test at 10 weeks compared to baseline. Change in Trail-Making-Test-A after 10 weeks compared to baseline. Change in Trail-Making-Test-B after 10 weeks compared to baseline. Change in Mini Mental Status Test at 10 weeks compared to baseline. Change in Patient Health Questionnaire-9 after 10 weeks compared to baseline. Change in the Montgomery Asberg Depression Rating Scale at 10 weeks compared to baseline. Change in ICD Symptom Rating Scale at 10 weeks compared to baseline. Change in Fatigue Assessment Scale after 10 weeks compared to baseline. Change in the Mini-International Neuropsychiatric Interview 7.0.2 after 10 weeks compared to baseline. Change in the Beck Depression Inventory 2 questionnaire after 10 weeks compared to baseline. Change in Hamilton anxiety scale at 10 weeks compared to baseline. Change in Snaith-Hamilton Pleasure Scale at 10 weeks compared to baseline. Change in the International Trauma Questionnaire after 10 weeks compared to baseline. Change in the Short Form 36 questionnaire after 10 weeks compared to the baseline. Change in the Edinburgh Handedness Inventory – Short Form questionnaire after 10 weeks compared to the baseline. Change in multiple-choice vocabulary intelligence test-B at 10 weeks compared to baseline. Change in pain questionnaire after 10 weeks compared to baseline. Change in screening for post-exertionelle malaise at 10 weeks compared to baseline. Correlation between symptoms and immunological/metabolic/brain biomarkers at 14 weeks compared to baseline. incidence of adverse events. | — |
Countries
Germany
Contacts
Public ContactBianca Besteher
Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Jena
Outcome results
None listed