Pycnogenol® in Post-COVID-19 Condition

NCT05890534 | Completed Phase 3 DMC

• 1 other identifier: 2022-01967
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post COVID-19 Condition; Long COVID

Keywords

COVID-19; post COVID symptoms; Pycnogenol®

Outcome Measures

Primary Outcomes (1)

• Health status (EQ-VAS)

  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.

  Change from baseline to 12 weeks

Secondary Outcomes (24)

• Post COVID-19 symptoms

  Change from baseline to 12 weeks

• Fatigue

  Change from baseline to 12 weeks

• Dyspnea

  Change from baseline to 12 weeks

• Cognitive function

  Change from baseline to 12 weeks

• Anxiety and depression

  Change from baseline to 12 weeks

Other Outcomes (2)

• Adherence to study products

  Baseline to 12 weeks

• Post-exertional malaise

  Baseline to 12 weeks

Study Arms (2)

Pycnogenol®

EXPERIMENTAL

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.

Drug: Pycnogenol®

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Pycnogenol® DRUG

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

Pycnogenol®

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

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

Zurich, 8001, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38879571 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jahn S Fehr, Prof., MD

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

  STUDY DIRECTOR

• Alexia Anagnostopoulos, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analyst is also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 6, 2023
• Study Start: June 7, 2023
• Primary Completion: November 5, 2024
• Study Completion: January 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)