2024-517713-33-00招募中2 期
A parallel-group treatment, phase 2a, double-blind, placebo-controlled 2-arm study to show improvement of physical function in SF-36 (SF-36-PF) in participants treated with Vericiguat compared to placebo tablets participants with post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of ME/CFS criteria - VERI-LONG
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Primary outcome is to show intra-patient change in SF-36-PF from baseline to week 10
研究概览
简要总结
To show improvement in SF-36-PF from baseline to week 10 when comparing Vericiguat with placebo based on mean differences.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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
次要结局
- 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.
研究者
Neuroimmunology Team, Clinical Research Unit, ECRC
Scientific
Charite Universitaetsmedizin Berlin KöR
研究点 (1)
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