Evaluating Vericiguat for Improving Physical Function in Post-COVID-19 Syndrome
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 in Male and Female Participants Aged 18-50 Years with Post-COVID-19 Syndrome Without (PCS) or with (PCS/CFS) Fulfillment of ME/CFS Criteria (VERI-LONG).
This study is testing if the medication Vericiguat can help people with post-COVID-19 syndrome feel less tired and improve their physical function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05697640 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Vericiguat, an approved medication, in alleviating symptoms of post-COVID-19 syndrome, particularly profound fatigue. Participants will be randomly assigned to receive either Vericiguat or a placebo for 10 weeks, followed by a 30-day follow-up period. The study aims to measure improvements in physical function using the SF-36 health questionnaire and assess any side effects associated with the treatment. The trial will also explore the underlying mechanisms of post-COVID-19 syndrome to inform future therapeutic developments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 with confirmed post-COVID-19 syndrome and evidence of endothelial dysfunction.
Not a fit: Patients with severe acute COVID-19 requiring hospitalization or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from post-COVID-19 syndrome by reducing fatigue and enhancing physical function.
How similar studies have performed: Preliminary evidence suggests that addressing endothelial dysfunction may be beneficial, but this specific approach with Vericiguat is novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Judith Bellmann-Strobl, MD — Charite University, Berlin, Germany
- Study coordinator: Judith Bellmann-Strobl, MD
- Email: veri-long@charite.de
- Phone: +49 30 450 540660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.