A study to investigate improvement in physical function in SF-36 with Vericiguat compared with Placebo in participants 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) criteria
- Registration Number
- 2024-517713-33-00
- Lead Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Brief Summary
To show improvement in SF-36-PF from baseline to week 10 when comparing Vericiguat with placebo based on mean differences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 104
Male or female adult who is 18-55 years old. Female study participants older than 50 years of age must either havea sustained menstrual cycle (as reported by the patient) or a FSH value < 20 IU/l)
Confirmed (PCR or serology), non-hospitalized, mild to moderate acute COVID-19 cases according to WHO criteria with proven chronic ED and either: ME/CFS CCC criteria with post exertional malaise (PEM) 2 - 14 hours = PCS or ME/CFS CCC criteria with PEM > 14 hours = PCS/CFS
Ongoing symptoms of PCS or PCS/CFS for ≥ 6 months
Bell Score: 30-60
Evidence for endothelial dysfunction (as indicated by RHI < 1.8 and/or Endothelin-1 level > 90 percentile of healthy age- and sex matched controls or muscle fatigue (below cut-off values of AUC reference values for age-matched healthy controls (Jaekel et al., 2021) and/or pathological OCTA)
Normal thyroid function
Subject is willing, understanding, and able to provide informed consent
Signed informed consent prior to initiation of any trial related measure
For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months) or For women of childbearing potential (WOCBP): Negative highly sensitive urine or serum pregnancy test before inclusion/randomisation and Practicing a highly effective birth control method (failure rate of less than 1%): a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or b) progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or c) intrauterine device, or d) intrauterine hormone-releasing system, or e) bilateral tubal occlusion, or f) vasectomised partner, or g) heterosexual abstinence.
COVID-19 vaccination within the last 4 weeks before inclusion
Systolic blood pressure: < 100 mmHg at screening
Contraindication against MRI investigation (e.g., stents, metal clips)
Severe hepatic insufficiency such as with hepatic encephalopathy or hepatic laboratory abnormalities (ALT or AST ≥3 × ULN or total bilirubin ≥2 × ULN) at screening.
BMI: > 32 kg/m2 at screening (provided that the patient's BMI was ≤ 30 kg/m2 in the medical history (according to the patient's information) before the COVID-19 infection that resulted in the post-COVID syndrome)
Subject is pregnant or breastfeeding at screening
Subject is institutionalized by order of court or public authority
Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient
Subject who might be dependent on the sponsor, the investigator, or the trial site
Participation in another clinical trial with an investigational medical product within 3 months or 5 half-lives, whichever is longer, before screening visit
Known SARS-CoV-2 infection-related organ damage/comorbidity
Renal impairment with an estimated glomerular filtration rate <15 mL/min/1.73 m2 or on dialysis at screening
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 preexisting Hashimoto thyroiditis and/or fibromyalgia without 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is to show intra-patient change in SF-36-PF from baseline to week 10 Primary outcome is to show intra-patient change in SF-36-PF from baseline to week 10
- Secondary Outcome Measures
Name Time Method Occurrence of responders. Responders are defined as an intra-patient 10-point increase in SF-36-PF from baseline to week 10; 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 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 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; 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. Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports.
Trial Locations
- Locations (1)
Charite Universitaetsmedizin Berlin KöR
🇩🇪Berlin, Germany
Charite Universitaetsmedizin Berlin KöR🇩🇪Berlin, GermanyJudith Bellmann-StroblSite contact+4930450540660judith.bellmann-strobl@charite.de