To determine the effect of Pycnogenol® versus placebo on patient-reported health statusin people with post COVID-19 condition.
The primary aim of this 12-week quadruple blind, single-center randomized controlled
trial is to determine the effect of Pycnogenol® (200mg daily) versus placebo on
patient-reported health status (EQ-Visual Analogue Scale) in people with post COVID-19
condition. Secondary outcomes include symptoms, fatigue, cognitive function,
health-related quality of life, functional exercise capacity and blood biomarkers of
inflammation, endothelial function and oxidative stress.
Pycnogenol® is a licensed pine tree bark extract (Pinus pinaster ssp. atlantica) and
primarly used for the treatment of venous disorders. Various studies reported beneficial
effects in other conditions such as diabetes, metabolic syndrome and cardiovascular
disorders. Pycnogenol® exerts antioxidative, anti-inflammatory and antiproliferative
effects and has been shown to improve vascular endothelial function. Pycnogenol® may have
potential to improve the health status of people suffering from post COVID-19 condition.
This trial lasts for 12 weeks. Participants are invited to visit the study center four
times: screening visit, baseline visit, follow-up 1 visit (6 weeks after baseline visit),
follow-up 2 visit (12 weeks after baseline visit).
In a substudy using baseline data, the investigators plan to study associations between
objectively measured physical activity, severity of post COVID-19 condition, symptom
burden and severity (e.g., fatigue, dyspnoea), functional exercise capacity, and
health-related quality of life.
Drug: Pycnogenol®
Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus
Placebo.
Drug: Placebo
Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus
Placebo.
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
will decide each case on an individual basis)
- COVID-19 vaccination less than 4 weeks prior to the baseline visit (i.e., first or
second dose of a two-dose vaccination regimen, first dose of a single dose
vaccination regimen, booster) or during study participation (booster shot will be
offered at screening visit, wait time until baseline visit 4 weeks)
- Known intolerance of the study drug
- Regular intake of Pycnogenol®
- Pregnancy or lactating. For women and transgender individuals of childbearing age,
who can anamnestically not exclude a pregnancy, are offered a pregnancy test during
the study visits.
- Being enrolled in another interventional study that may interfere with the current
study (the responsible study physician will decide each case on an individual basis)
University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Department of Public & Global Health
Zürich, Switzerland