Evidence map›Paper›PMID 38879571›Full record

ArticleTrials2024

Effects of Pycnogenol® in people with post-COVID-19 condition (PYCNOVID): study protocol for a single-center, placebo controlled, quadruple-blind, randomized trial.

Thomas Radtke, Lisa Künzi, Julia Kopp, Manuela Rasi, Julia Braun, Kyra D Zens, Babette Winter, Alexia Anagnostopoulos, Milo A Puhan, Jan S Fehr

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05890534 (Pycnogenol® in People With Post-COVID-19 Condition), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05890534 phase3completednot on this map

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

TypeinterventionalSponsorUniversity of ZurichRan2023 to 2025Enrolled153ConditionsPost COVID-19 Condition, Long COVIDArmsPycnogenol®, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Thomas Radtke *Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland. thomas.radtke@uzh.ch.ORCID http://orcid.org/0000-0002-1723-1070
Lisa Künzi *Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0003-1862-2994
Julia KoppEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0009-0000-7871-8707
Manuela RasiEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.
Julia BraunEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0001-8359-6177
Kyra D ZensEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0001-7979-076X
Babette WinterEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0001-8293-9844
Alexia AnagnostopoulosEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0001-6197-3023
Milo A PuhanEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0003-4721-1879
Jan S FehrEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), Zurich, Switzerland.ORCID http://orcid.org/0000-0003-1113-9895

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA significant proportion of the global population has been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at some point since the onset of the pandemic. Although most individuals who develop coronavirus disease 2019 (COVID-19) recover without complications, about 6% have persistent symptoms, referred to as post-COVID-19 condition (PCC). Intervention studies investigating treatments that potentially alleviate PCC-related symptoms and thus aim to mitigate the global public health burden and healthcare costs linked to PCC are desperately needed. The PYCNOVID trial investigates the effects of Pycnogenol®, a French maritime pine bark extract with anti-inflammatory and antioxidative properties, versus placebo on patient-reported health status in people with PCC.

methodsThis is a single-center, placebo-controlled, quadruple blind, randomized trial. We aim to randomly assign 150 individuals with PCC (1:1 ratio) to receive either 200 mg Pycnogenol® or placebo daily for 12 weeks. Randomization is stratified for duration of PCC symptoms (≤ 6 months versus > 6 months) and presence of symptomatic chronic disease(s). The primary endpoint is perceived health status at 12 weeks (EuroQol-Visual Analogue Scale) adjusted for baseline values and stratification factors. Secondary endpoints include change in self-reported PCC symptoms, health-related quality of life, symptoms of depression and anxiety, cognitive function, functional exercise capacity, physical activity measured with accelerometry, and blood biomarkers for endothelial health, inflammation, coagulation, platelet function, and oxidative stress. Investigators, study participants, outcome assessors, and data analysts are blinded regarding the intervention assignment. Individuals with PCC were involved in the design of this study. DISCUSSION: This is the first trial to investigate the effects of Pycnogenol® versus placebo on patient-reported health status in people with PCC. Should the trial proof clinical effectiveness, Pycnogenol® may serve as a therapeutic approach to mitigate symptoms associated with PCC.

trial registrationThe study is registered at ClinicalTrials.gov. :NCT05890534, June 6, 2023.

Indexed as

FlavonoidsPlant ExtractsAdultAnti-Inflammatory AgentsAntioxidantsCOVID-19COVID-19 Drug TreatmentFemaleHealth StatusHumansMalePost-Acute COVID-19 SyndromeQuality of LifeRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeAnti-Inflammatory AgentsAntioxidantsFlavonoidsPlant ExtractspycnogenolsCoronavirusCOVID-19Long COVIDPost-COVID-19 conditionPycnogenol®SARS-CoV-2

Identifiers

PMID38879571
PMCPMC11179231

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.