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NCT05697640Active, 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

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).

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
104 (estimated)
First submitted
23 Jan 2023
Start date
22 Jun 2023
Primary completion date
1 Apr 2026
Lead sponsor
Charite University, Berlin, Germany
NCT number
NCT05697640
EU CT number
2024-517713-33-00
EudraCT number
2021-005494-11

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 104
  • From 22 Jun 2023 to the primary completion date, 1 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • COVID-19 vaccination within the last 4 weeks before inclusion
  • Concomitant use of Vericiguat due to other diseases
  • Concurrent or anticipated concomitant use of PDE-5 inhibitors such as vardenafil, tadalafil, and sildenafil, nitrates, or sGC-stimulators

Other illness

  • Pre-COVID history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g., cancer, autoimmune diseases \[patients with a preexisting Hashimoto thyroiditis and/or fibromyalgia without fatigue syndromes can be included\])
  • Hypersensitivity to the active substance or any of the other ingredients
  • Known SARS-CoV-2 infection-related organ damage/comorbidity
  • Severe renal or hepatic insufficiency

Other

  • Contraindications against IMP
  • Use of other sGC stimulators, e.g., riociguat
  • Systolic blood pressure: \< 100 mmHg at screening
  • Pregnancy or breastfeeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status		BerlinGermanyCompleted

This page is information, not medical advice. Discuss any trial with your doctor.