Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome
Post-COVID ME/CFS
About this trial
This is an interventional treatment trial for Post-COVID ME/CFS focused on measuring Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
Eligibility Criteria
Inclusion Criteria: Male or female adult who is 18-50 years old 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 Canadian Consensus Criteria (CCC) 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 (ED) [as indicated by reactive 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 area under the curve 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/randomisation and practicing a highly effective birth control method (failure rate of less than 1 %): combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal), or progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomised partner, or heterosexual abstinence. 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 preexisting Hashimoto thyroiditis and/or fibromyalgia without fatigue syndromes can be included]) Concomitant use of Vericiguat due to other diseases 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: < 100 mmHg at screening Known SARS-CoV-2 infection-related organ damage/comorbidity Severe renal or hepatic insufficiency Pregnancy or breastfeeding
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Vericiguat Oral Tablet
Placebo Oral Tablet
Tested IMP: Vericiguat (film-coated tablet). Authorization status: Not authorised in this targeted therapeutic indication; Vericiguat is authorized for the dosages that will be administered in this trial for another indication. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks. The general IMP titration regimen was investigated and proven to be safe (max. dosages 10 mg/day) in patients with heart failure and reduced ejection fraction (Armstrong et al., 2020).
Comparator IMP: Placebo (film-coated tablet). Authorization status: Not authorised. The tablets used in this trial are no trade product, but a special trial product produced and provided by the marketing authorization holder Bayer. Administration: Once daily (oral). Planned dosage: Three different dosages starting with 2.5 mg for two weeks, followed by 5 mg for two weeks and 10 mg for six weeks to have identical conditions to verum.