Pycnogenol® in People With Post-COVID-19 Condition: a Quadruple-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Health status (EQ-VAS)
研究概览
简要总结
To determine the effect of Pycnogenol® versus placebo on patient-reported health status in people with post COVID-19 condition.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data analyst is also masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Pycnogenol®
People with post COVID-19 condition randomly allocated to the Pycnogenol® arm will take 4 capsules of Pycnogenol® per day (4x50mg capsules, 200mg total) over a period of 12 weeks.
干预措施: Pycnogenol® (Drug)
Placebo
People with post COVID-19 condition randomly allocated to the Placebo arm will take 4 capsules of Placebo per day (4x50mg capsules, 200mg total) over a period of 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Health status (EQ-VAS)
时间窗: Change from baseline to 12 weeks
EQ-Visual Analogue Scale (EQ-VAS also known as "Feeling thermometer") assessed daily over 7 consecutive days prior to the baseline and at the end of the follow-up 2 visit (i.e., study end after 12 weeks). The scale ranges from 0-100 with 0 representing worst health status and 100 representing best health status.
次要结局
- Dyspnea(Change from baseline to 12 weeks)
- Activated partial thromboplastin time (aPTT)(Change from baseline to 12 weeks)
- Post COVID-19 symptoms(Change from baseline to 12 weeks)
- Fatigue(Change from baseline to 12 weeks)
- von Willebrand Factor antigen (VWF:Ag)(Change from baseline to 12 weeks)
- Cognitive function(Change from baseline to 12 weeks)
- Functional exercise capacity(Change from baseline to 12 weeks)
- Physical activity(Change from baseline to 12 weeks)
- Interleukine 6 (IL 6)(Change from baseline to 12 weeks)
- Total antioxidant capacity (TAC)(Change from baseline to 12 weeks)
- Alanine aminotransferase (ALAT)(Change from baseline to 12 weeks)
- Anxiety and depression(Change from baseline to 12 weeks)
- Health-related quality of life (EQ-5D-5L)(Change from baseline to 12 weeks)
- Soluble Thrombomodulin (sTM)(Change from baseline to 12 weeks)
- Syndecan-1(Change from baseline to 12 weeks)
- Circulating Cascular Cell Adhesion Molecule-1 (sVCAM 1)(Change from baseline to 12 weeks)
- C-reative protein (CRP)(Change from baseline to 12 weeks)
- sCD40L(Change from baseline to 12 weeks)
- sP selectin(Change from baseline to 12 weeks)
- D-Dimer(Change from baseline to 12 weeks)
- International normalized ratio (INR) blood test(Change from baseline to 12 weeks)
- Aspartate aminotransferase (ASAT)(Change from baseline to 12 weeks)
- Gamma glutamyltransferase (γ-GT)(Change from baseline to 12 weeks)
- Creatinine(Change from baseline to 12 weeks)