A study to investigate improvement in physical function with Vericiguat compared with Placebo in participants aged 18 to 50 years with post-COVID-19 syndrome (PCS and PCS/CFS)
- Conditions
- Post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of myalgic encephalomyelitis/chronic fatique syndrome (ME/CFS) criteriaMedDRA version: 24.1Level: LLTClassification code 10085867Term: Post-COVID-19 syndromeSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-005494-11-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 104
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)<1.8 and/or ET-1 level > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1)The occurrenceof SF-36-PF responder(10-point increase);<br>2)Improvement in other SF-36 sub-domains from baseline to week 10 when comparing Vericiguat with placebo;<br>3)An improvement in fatigue severity scalefrom baseline to week 10 when comparing Vericiguat with placebo;<br>4)An improvement in muscle fatigue assessedby repetitive hand grip strength (HGS) test from screening to week 10 when comparing Vericiguat with placebo<br>;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 Outcome Measures
Name Time Method Secondary end point(s): Main secondary endpointswilldemonstrate:<br>1) Occurrenceof responders. Responders aredefined as an intra-patient 10-point increase in SF-36-PF from baseline to week 10;<br>2) Intra-patient change in other SF-36 subdomains from baseline to week 10;<br>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;<br>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