NCT05890534

Pycnogenol® in Post-COVID-19 Condition

Pycnogenol® in People With Post-COVID-19 Condition: a Quadruple-blind, Randomized, Placebo-controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect of Pycnogenol® versus placebo on patient-reported health status in people with post COVID-19 condition.

Detailed description

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.

Conditions

• Post COVID-19 Condition
• Long COVID

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-07
• Primary completion: 2024-11-05
• Completion: 2024-12-31
• First posted: 2023-06-06
• Last updated: 2024-08-13

Locations

1 site across 1 country: Switzerland