BridgeMD
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)
EU CTIS ID: 2024-517713-33-00
What this study is testing
To show improvement in SF-36-PF from baseline to week 10 when comparing Vericiguat with placebo based on mean differences.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.