Post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of myalgic encephalomyelitis/chronic fatique syndrome (ME/CFS) criteria
Conditions
Brief summary
Primary outcome is to show intra-patient change in SF-36-PF from baseline to week 10
Detailed description
Occurrence of responders. Responders are defined as an intra-patient 10-point increase in SF-36-PF from baseline to week 10;, Intra-patient change in other SF-36 subdomains from baseline to week 10;, Intra-patient change in fatigue severity scale from baseline to week 10;, Intra-patient change in hand grip force (maximum, mean), fatigue ratio, and recovery rate from screening to week 10;, Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports.
Interventions
DRUGPL1: placebo for Vericiguat
DRUGMK-1242
DRUG2.5 mg and 5 mg; composition identical to the IMP
DRUGVericiguat
DRUGPL2: placebo for Vericiguat
DRUG10 mg; composition identical to the IMP
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to show intra-patient change in SF-36-PF from baseline to week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of responders. Responders are defined as an intra-patient 10-point increase in SF-36-PF from baseline to week 10;, Intra-patient change in other SF-36 subdomains from baseline to week 10;, Intra-patient change in fatigue severity scale from baseline to week 10;, Intra-patient change in hand grip force (maximum, mean), fatigue ratio, and recovery rate from screening to week 10;, Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports. | — |
Countries
Germany
Outcome results
None listed