Study on the effect of Pycnogenol® in individuals with Post-COVID-19 syndrome (PYCNOVID Study)
Résumé de l'étude
The PYCNOVID study investigates whether Pycnogenol® leads to an improvement in the general health status of individuals with Post-COVID-19 syndrome. Pycnogenol® is an extract from the bark of French maritime pines (pinus pinaster subsp., atlantica, pinaceae) and contains a mixture of various naturally occurring plant substances. It is particularly rich in natural plant pigments (flavonoids), which have antioxidant properties. Moreover, various studies show that Pycnogenol® has anti-inflammatory effects and positively influences blood coagulation. Pycnogenol® has been available on the market for about 50 years. In Switzerland, the product is available over the counter for the treatment of venous diseases and is used as a supportive treatment for varicose veins and feelings of heaviness in the legs. Additionally, clinical studies have found positive effects, for example, in cardiovascular diseases, diabetes, and inflammatory skin diseases. The PYCNOVID study is a randomized, placebo-controlled, double-blind clinical trial. The study investigates whether there is an improvement in health status among Post-COVID-19 patients through the intake of Pycnogenol® over 12 weeks compared to the placebo preparation. The placebo capsules are indistinguishable in appearance from the Pycnogenol® capsules. The study is double-blind, meaning that until the study is completed, no one involved (study participants, examiners, and other study staff) knows whether the individual participants received Pycnogenol® or placebo.
(BASEC)
Intervention étudiée
We plan to examine 150 individuals with Post-COVID-19 syndrome. Participants will be randomly assigned at the beginning of the study to either a treatment or control group. The chance for each participant to receive Pycnogenol® is equal to that of receiving placebo capsules (50:50). Both treatment groups will take two capsules each morning and evening for 12 weeks (200 mg Pycnogenol® / day or placebo). The control group will receive placebo capsules that cannot be distinguished from the Pycnogenol® capsules. Whether the individual participants receive Pycnogenol® or placebo capsules will only be revealed after the completion of the study.
(BASEC)
Maladie en cours d'investigation
According to population-based studies, about 20-30% of individuals infected with the coronavirus (SARS-CoV-2) experience lasting complaints after the acute illness has subsided. Affected individuals suffer from many different physical and psychological symptoms, described by various terms such as "Post-COVID-19 syndrome" or "Post-COVID-19 condition." Post-COVID-19 syndrome is defined by the World Health Organization (WHO) as the presence of symptoms that last longer than two months, are still present three months after the onset of a COVID-19 illness, and cannot be explained by another cause. According to current knowledge, there are various causes for the symptoms described by affected individuals, such as chronic inflammatory reactions or changes in blood vessels. So far, there is no scientifically proven effective treatment for Post-COVID-19 syndrome, and the research into therapies is receiving significant attention worldwide.
(BASEC)
• Minimum age of 18 years • Evidence of a past coronavirus infection through a positive PCR test or antigen rapid test for professional use or confirmation by the treating physician • Persistent or recurrent complaints after the past coronavirus infection that cannot be explained by another cause (Post-COVID-19 condition according to WHO definition) • Existing symptoms include at least one of the following four symptoms: severe fatigue (fatigue) and/or exercise intolerance ("post-exertional malaise") and/or cognitive impairment (e.g., reduced concentration ability) and/or breathing difficulties • No planned or foreseeable changes in current medication or therapies during study participation, i.e., existing therapies can be continued unchanged. • Able to understand the study documents and content in German • Capable of participating in study visits • Written consent to participate in the study (BASEC)
Critères d'exclusion
• Severe comorbidities such as liver or kidney failure, advanced chronic lung disease, active cancer, heart failure, serious cardiovascular event within the last 24 weeks (e.g., heart attack, stroke), uncontrolled severe hypertension, poorly controlled diabetes, uncontrolled inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) • Untreated psychiatric disorder (e.g., depression, anxiety disorder, schizophrenia) • In case of acute respiratory infection or other infections, the start of study participation will be postponed until the infection has resolved for at least 14 days. • COVID-19 vaccination during study participation (as part of the pre-evaluations for potential study participation, a COVID vaccination may be offered on-site if desired) • Known intolerances to the study product • Regular intake of the study product in the 4 weeks prior to the start of the study • Pregnancy or breastfeeding • Participation in another study involving an intervention (e.g., a therapy) that could impact the current study Important: The study products (Pycnogenol® and placebo) contain animal gelatin. Individuals following a vegan or vegetarian diet can decide for themselves whether they wish to participate. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Universität Zürich Institut für Epidemiologie, Biostatistik und Prävention Departement Public & Global Health
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Jan Fehr
+41446344604
jan.fehr@clutteruzh.chUniversität Zürich Institut für Epidemiologie, Biostatistik und Prävention Departement Public & Global Health Zentrum für Reisemedizin und Übertragbare Krankheiten Hirschengraben 84 8001 Zürich
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
07.03.2023
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Pycnogenol® in people with post-COVID-19 condition: a quadruple-blind, randomized, placebo-controlled trial (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
zusammenfassung-teilnehmende-250612.pdfLien vers les résultats dans le registre primaire
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