Pycnogenol® in Post-COVID-19 Condition (NCT05890534) | Clinical Trial Compass
CompletedPhase 3
Pycnogenol® in Post-COVID-19 Condition
Switzerland153 participantsStarted 2023-06-07
Plain-language summary
To determine the effect of Pycnogenol® versus placebo on patient-reported health status in people with post COVID-19 condition.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* SARS-CoV-2 infection confirmed by positive PCR or rapid antigen test for professional use or written medical report
* Post-COVID condition (WHO definition), i.e., ≥ 3 months after SARS-CoV2 infection and ongoing or recurring symptoms for at least 2 months that cannot be explained by alternative diagnosis
* Symptoms include fatigue and / or cognitive impairment ("brain fog") and / or dyspnea and / or post-exertional malaise
* Willing to participate and having signed informed consent
* Sufficient language and cognitive skills
* Ability to participate in study visits
* No foreseeable change in medication
Exclusion Criteria:
* Severe comorbidities such as liver or renal failure, advanced COPD or pulmonary fibrosis requiring \> 5L oxygen/min at rest, active malignancy, advanced heart failure, cardio-vascular events within the previous 24 weeks (such as unstable coronary artery disease, coronary revascularization, myocardial infarction, stroke, transient ischemic attack, critical limb ischemia, pulmonary embolism, deep vein thrombosis), uncontrolled severe hypertension, uncontrolled diabetes uncontrolled autoimmune or inflammatory disease (the responsible study physician will decide each case on an individual basis)
* Acute respiratory or other infections (postpone baseline visit until resolved)
* Clinical diagnosis of a psychiatric disease (e.g., depression, anxiety disorder, schizophrenia) that is untreated and/or unstable (the responsible study physician…