Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Plac… (NCT05697640) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome
Germany104 participantsStarted 2023-06-22
Plain-language summary
The goal of this clinical trial is to evaluate the therapeutic value of an approved drug (Vericiguat) in patients with post-COVID-19 syndrome, who suffer from profound tiredness or fatigue, regardless of bed rest.The main questions it aims to answer are: • Does Vericiguat relieve fatigue and/or other symptoms associated with post-COVID-19 syndrome? • What are the side effects of Vericiguat in this patient population; and how common are they?
Participants will be asked to participate for approx. 18 weeks. After screening, participants will receive assigned intervention of either 10 weeks of treatment with Vericiguat or matching placebo tablet, followed by 30 day follow-up period. Every participant will undergo trial, cardiovascular safety, and monitoring assessments.
The results of this study will provide information on whether Vericiguat can alleviate PCS-related symptoms as well as insights into the pathophysiological processes of PCS, which in turn can help to develop therapies.
Who can participate
Age range18 Years – 50 Years
SexALL
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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
* va…
What they're measuring
1
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)