Pycnogenol® in Post-COVID-19 Condition

NCT ID: NCT05890534

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pycnogenol®

Intervention Type: DRUG

Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus Placebo.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus Placebo.

Interventions

Pycnogenol®

Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus Placebo.

Intervention Type: DRUG

Placebo

Single center, quadruple blind randomized controlled trial comparing Pycnogenol® versus Placebo.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jahn S Fehr, Prof., MD

Role: STUDY_DIRECTOR

University of Zurich, EBPI, Department of Public & Global Health

Alexia Anagnostopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, EBPI, Department of Public & Global Health

Locations

University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Department of Public & Global Health

Zurich, , Switzerland

Countries

Switzerland

References

Radtke T, Kunzi L, Kopp J, Rasi M, Braun J, Zens KD, Winter B, Anagnostopoulos A, Puhan MA, Fehr JS. Effects of Pycnogenol(R) in people with post-COVID-19 condition (PYCNOVID): study protocol for a single-center, placebo controlled, quadruple-blind, randomized trial. Trials. 2024 Jun 15;25(1):385. doi: 10.1186/s13063-024-08187-6.

Reference Type: DERIVED

PMID: 38879571 (View on PubMed)

Other Identifiers

2022-01967

Identifier Type: -

Identifier Source: org_study_id