Post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of myalgic encephalomyelitis/chronic fatique syndrome (ME/CFS) criteria MedDRA version: 24.1 Level: LLT Classification code 10085867 Term: Post-COVID-19 syndrome System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Vericiguat 2,5 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Vericiguat
CAS Number: 1350653-20-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: - Male or female adult who is 18-50 years old - Confirmed (PCRor serology),non-hospitalized, mild to moderate acute COVID-19 cases according to WHO criteria with proven chronic ED and either: ME/CFS CCC criteriawithpost exertional malaise(PEM)2 -14 hours = PCS orME/CFS CCC criteria with PEM > 14 hours = PCS/CFS - Ongoing symptoms of PCSor PCS/CFSfor= 6 months - Bell Score: 30-60 - Evidence for ED [as indicated byreactive hyperemia index(RHI) 90 percentile of healthy age-and gender matched controls or muscle fatigue (below cut-off values of AUC reference values for age-matched healthy controls and/or pathological optical coherence tomography angiography(OCTA))] - For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months) or for women of childbearing potential: Negative highly sensitive urine or serum pregnancy test before inclusion/randomisationandPracticing a highly effective birth control method (failure rate of less than 1%) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria: - COVID-19 vaccination within the last 4 weeks before inclusion - Pre-COVID history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g.,cancer, autoimmune diseases [patients with a preexcisting Hashimoto thyroiditis and/orfibromyalgiawithout fatigue syndromes can be included]) - Concomitant or previous use of Vericiguat - Contraindications against IMP - Concurrent or anticipated concomitant use of PDE-5 inhibitors such as vardenafil, tadalafil, and sildenafil, nitrates,or sGC-stimulators - Use of other sGC stimulators, e.g.,riociguat - Hypersensitivity to the active substance or any of the other ingredients - Systolic blood pressure: < 100mmHg at screening ?Known SARS-CoV-2 infection-related organ damage/comorbidity?Severe renal or hepatic insufficiency - Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show improvementin SF-36-PFfrom baseline to week 10 when comparing Vericiguat with placebo based on mean differences.;Secondary Objective: Main secondary objective(s)are to show differences in: 1)The occurrenceof SF-36-PF responder(10-point increase); 2)Improvement in other SF-36 sub-domains from baseline to week 10 when comparing Vericiguat with placebo; 3)An improvement in fatigue severity scalefrom baseline to week 10 when comparing Vericiguat with placebo; 4)An improvement in muscle fatigue assessedby repetitive hand grip strength (HGS) test from screening to week 10 when comparing Vericiguat with placebo ;5)Assessmentof investigational medical product (IMP) safety and side/adverse effects during the IMP intake and titration regimen.;Primary end point(s): Primary endpoint: Primary outcome is toshowintra-patient change in SF-36-PF from baseline to week 10;Timepoint(s) of evaluation of this end point: Baseline and week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main secondary endpointswilldemonstrate: 1) Occurrenceof responders. Responders aredefined as an intra-patient 10-point increase in SF-36-PF from baseline to week 10; 2) Intra-patient change in other SF-36 subdomains from baseline to week 10; 3) Intra-patient change in fatigue severity scale from baseline to week 10;4)Intra-patient change inhand grip force(maximum, mean), fatigue ratio,and recovery rate from screening to week 10; 5) Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports.;Timepoint(s) of evaluation of this end point: Baseline and week 10 | — |
Countries
Germany
Contacts
Public ContactInstitut für Med. Immunologie
Charité - Universitätsmedizin Berlin
Outcome results
None listed