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Article ; Online: Remdesivir, on the road to DisCoVeRy.

Gyselinck, Iwein / Janssens, Wim

2021 Volume 22, Issue 2, Page(s) 153–155

MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Humans
Chemical Substances	remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-09-14
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(21)00559-4
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Article ; Online: Chronic Obstructive Pulmonary Disease Exacerbations: Do All Roads Lead to Rome?

Ramakrishnan, Sanjay / Gyselinck, Iwein / Bafadhel, Mona / Janssens, Wim

American journal of respiratory and critical care medicine

2022 Volume 205, Issue 9, Page(s) 1125–1126

MeSH term(s)	Disease Progression ; Humans ; Pulmonary Disease, Chronic Obstructive/therapy ; Rome
Language	English
Publishing date	2022-02-22
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202112-2717LE
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Article ; Online: Rationale for azithromycin in COVID-19

Iwein Gyselinck / Robin Vos

BMJ Open Respiratory Research, Vol 8, Iss

an overview of existing evidence

2021 Volume 1

Abstract: Azithromycin has rapidly been adopted as a repurposed drug for the treatment of COVID-19, despite the lack of high-quality evidence. In this review, we critically appraise the current pharmacological, preclinical and clinical data of azithromycin for ... ...

Abstract	Azithromycin has rapidly been adopted as a repurposed drug for the treatment of COVID-19, despite the lack of high-quality evidence. In this review, we critically appraise the current pharmacological, preclinical and clinical data of azithromycin for treating COVID-19. Interest in azithromycin has been fuelled by favourable treatment outcomes in other viral pneumonias, a documented antiviral effect on SARS-CoV-2 in vitro and uncontrolled case series early in the pandemic. Its antiviral effects presumably result from interfering with receptor mediated binding, viral lysosomal escape, intracellular cell-signalling pathways and enhancing type I and III interferon expression. Its immunomodulatory effects may mitigate excessive inflammation and benefit tissue repair. Currently, in vivo reports on azithromycin in COVID-19 are conflicting and do not endorse its widespread use outside of clinical trials. They are, however, mostly retrospective and therefore inherently biased. The effect size of azithromycin may depend on when it is started. Also, extended follow-up is needed to assess benefits in the recovery phase. Safety data warrant monitoring of drug–drug interactions and subsequent cardiac adverse events, especially with hydroxychloroquine. More prospective data of large randomised controlled studies are expected and much-needed. Uniform reporting of results should be strongly encouraged to facilitate data pooling with the many ongoing initiatives.
Keywords	Medicine ; R ; Diseases of the respiratory system ; RC705-779
Subject code	610
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Rationale for azithromycin in COVID-19: an overview of existing evidence.

Gyselinck, Iwein / Janssens, Wim / Verhamme, Peter / Vos, Robin

BMJ open respiratory research

2020 Volume 8, Issue 1

Abstract	Azithromycin has rapidly been adopted as a repurposed drug for the treatment of COVID-19, despite the lack of high-quality evidence. In this review, we critically appraise the current pharmacological, preclinical and clinical data of azithromycin for treating COVID-19. Interest in azithromycin has been fuelled by favourable treatment outcomes in other viral pneumonias, a documented antiviral effect on SARS-CoV-2 in vitro and uncontrolled case series early in the pandemic. Its antiviral effects presumably result from interfering with receptor mediated binding, viral lysosomal escape, intracellular cell-signalling pathways and enhancing type I and III interferon expression. Its immunomodulatory effects may mitigate excessive inflammation and benefit tissue repair. Currently, in vivo reports on azithromycin in COVID-19 are conflicting and do not endorse its widespread use outside of clinical trials. They are, however, mostly retrospective and therefore inherently biased. The effect size of azithromycin may depend on when it is started. Also, extended follow-up is needed to assess benefits in the recovery phase. Safety data warrant monitoring of drug-drug interactions and subsequent cardiac adverse events, especially with hydroxychloroquine. More prospective data of large randomised controlled studies are expected and much-needed. Uniform reporting of results should be strongly encouraged to facilitate data pooling with the many ongoing initiatives.
MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Azithromycin/therapeutic use ; Humans ; SARS-CoV-2 ; Treatment Outcome ; COVID-19 Drug Treatment
Chemical Substances	Anti-Bacterial Agents ; Azithromycin (83905-01-5)
Language	English
Publishing date	2020-09-24
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2736454-9
ISSN	2052-4439 ; 2052-4439
ISSN (online)	2052-4439
ISSN	2052-4439
DOI	10.1136/bmjresp-2020-000806
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Article ; Online: Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials.

Verstraete, Kenneth / Gyselinck, Iwein / Huts, Helene / Das, Nilakash / Topalovic, Marko / De Vos, Maarten / Janssens, Wim

Thorax

2023 Volume 78, Issue 10, Page(s) 983–989

Abstract: Rationale: Estimating the causal effect of an intervention at individual level, also called individual treatment effect (ITE), may help in identifying response prior to the intervention.: Objectives: We aimed to develop machine learning (ML) models ... ...

Abstract	Rationale: Estimating the causal effect of an intervention at individual level, also called individual treatment effect (ITE), may help in identifying response prior to the intervention. Objectives: We aimed to develop machine learning (ML) models which estimate ITE of an intervention using data from randomised controlled trials and illustrate this approach with prediction of ITE on annual chronic obstructive pulmonary disease (COPD) exacerbation rates. Methods: We used data from 8151 patients with COPD of the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) trial (NCT01313676) to address the ITE of fluticasone furoate/vilanterol (FF/VI) versus control (placebo) on exacerbation rate and developed a novel metric, Q-score, for assessing the power of causal inference models. We then validated the methodology on 5990 subjects from the InforMing the PAthway of COPD Treatment (IMPACT) trial (NCT02164513) to estimate the ITE of FF/umeclidinium/VI (FF/UMEC/VI) versus UMEC/VI on exacerbation rate. We used Causal Forest as causal inference model. Results: In SUMMIT, Causal Forest was optimised on the training set (n=5705) and tested on 2446 subjects (Q-score 0.61). In IMPACT, Causal Forest was optimised on 4193 subjects in the training set and tested on 1797 individuals (Q-score 0.21). In both trials, the quantiles of patients with the strongest ITE consistently demonstrated the largest reductions in observed exacerbations rates (0.54 and 0.53, p<0.001). Poor lung function and blood eosinophils, respectively, were the strongest predictors of ITE. Conclusions: This study shows that ML models for causal inference can be used to identify individual response to different COPD treatments and highlight treatment traits. Such models could become clinically useful tools for individual treatment decisions in COPD.
MeSH term(s)	Humans ; Administration, Inhalation ; Lung ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Androstadienes/therapeutic use ; Androstadienes/pharmacology ; Benzyl Alcohols/therapeutic use ; Benzyl Alcohols/pharmacology ; Chlorobenzenes/therapeutic use ; Chlorobenzenes/pharmacology ; Bronchodilator Agents/therapeutic use ; Drug Combinations ; Double-Blind Method ; Treatment Outcome ; Randomized Controlled Trials as Topic
Chemical Substances	Androstadienes ; Benzyl Alcohols ; Chlorobenzenes ; Bronchodilator Agents ; Drug Combinations
Language	English
Publishing date	2023-04-03
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	204353-1
ISSN	1468-3296 ; 0040-6376
ISSN (online)	1468-3296
ISSN	0040-6376
DOI	10.1136/thorax-2022-219382
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Article ; Online: Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial.

Gyselinck, Iwein / Liesenborghs, Laurens / Landeloos, Ewout / Belmans, Ann / Verbeke, Geert / Verhamme, Peter / Vos, Robin / Janssens, W

Trials

2021 Volume 22, Issue 1, Page(s) 187

Language	English
Publishing date	2021-03-05
Publishing country	England
Document type	Published Erratum
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05153-4
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Article ; Online: Principal component analysis of flow-volume curves in COPDGene to link spirometry with phenotypes of COPD.

Verstraete, Kenneth / Das, Nilakash / Gyselinck, Iwein / Topalovic, Marko / Troosters, Thierry / Crapo, James D / Silverman, Edwin K / Make, Barry J / Regan, Elizabeth A / Jensen, Robert / De Vos, Maarten / Janssens, Wim

Respiratory research

2023 Volume 24, Issue 1, Page(s) 20

Abstract: Background: Parameters from maximal expiratory flow-volume curves (MEFVC) have been linked to CT-based parameters of COPD. However, the association between MEFVC shape and phenotypes like emphysema, small airways disease (SAD) and bronchial wall ... ...

Abstract	Background: Parameters from maximal expiratory flow-volume curves (MEFVC) have been linked to CT-based parameters of COPD. However, the association between MEFVC shape and phenotypes like emphysema, small airways disease (SAD) and bronchial wall thickening (BWT) has not been investigated. Research question: We analyzed if the shape of MEFVC can be linked to CT-determined emphysema, SAD and BWT in a large cohort of COPDGene participants. Study design and methods: In the COPDGene cohort, we used principal component analysis (PCA) to extract patterns from MEFVC shape and performed multiple linear regression to assess the association of these patterns with CT parameters over the COPD spectrum, in mild and moderate-severe COPD. Results: Over the entire spectrum, in mild and moderate-severe COPD, principal components of MEFVC were important predictors for the continuous CT parameters. Their contribution to the prediction of emphysema diminished when classical pulmonary function test parameters were added. For SAD, the components remained very strong predictors. The adjusted R Interpretation: The shape of the maximal expiratory flow-volume curve as analyzed with PCA is not an appropriate screening tool for early disease phenotypes identified by CT scan. However, it contributes to assessing emphysema and SAD in moderate-severe COPD.
MeSH term(s)	Humans ; Principal Component Analysis ; Smoking ; Pulmonary Disease, Chronic Obstructive/diagnosis ; Pulmonary Disease, Chronic Obstructive/genetics ; Pulmonary Emphysema ; Emphysema ; Spirometry ; Phenotype ; Forced Expiratory Volume
Language	English
Publishing date	2023-01-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2041675-1
ISSN	1465-993X ; 1465-993X
ISSN (online)	1465-993X
ISSN	1465-993X
DOI	10.1186/s12931-023-02318-4
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Article ; Online: Factors associated to physical activity in patients with COPD: An ecological approach.

Blondeel, Astrid / Hermans, Fien / Breuls, Sofie / Wuyts, Marieke / Everaerts, Stephanie / Gyselinck, Iwein / De Maeyer, Nikolaas / Verniest, Thessa / Derom, Eric / Janssens, Wim / Troosters, Thierry / Demeyer, Heleen

Respiratory medicine

2023 Volume 219, Page(s) 107424

Abstract: Background: Physical activity (PA) is low in patients with Chronic Obstructive Pulmonary Disease (COPD). Identifying modifiable and non-modifiable correlates of PA give understanding of the individual behavior and provide future directions for PA ... ...

Abstract	Background: Physical activity (PA) is low in patients with Chronic Obstructive Pulmonary Disease (COPD). Identifying modifiable and non-modifiable correlates of PA give understanding of the individual behavior and provide future directions for PA enhancing interventions. As PA is complex and multidimensional, it should be embedded within a thorough framework. Objective: To identify correlates of PA in a comprehensive COPD population based on a broad ecological model, including physiological, psychological, socio-demographic and environmental dimensions. Methods: PA was objectively measured using the Dynaport Movemonitor and a comprehensive data collection of physiological, psychological, socio-demographic and environmental factors were collected. Bivariable and multivariable regression analyses (including principle component analysis) were executed. Results: For this cross-sectional analysis, we included 148 patients with COPD and valid PA data (mean (SD) age 68 (7) years, FEV1 57 (17) % predicted, 5613 (3596) steps per day). Significant bivariable associations were found for physiological (exercise capacity, muscle force, lung function, symptoms, comorbidities), psychological (e.g. fatigue, motivation, perceived difficulty with PA), socio-demographic (dog owning, use of activity tracker) and environmental (season, daylight, temperature) factors. Based on the multivariable regression model, exercise capacity, beliefs on motivation, importance and self-confidence regarding PA and weather conditions were independent correlates of mean steps per day (R Conclusion: Although a wide range of potential influence factors were evaluated, variance in PA was only partly explained, supporting that PA is a complex behavior which is difficult to predict.
MeSH term(s)	Humans ; Animals ; Dogs ; Aged ; Cross-Sectional Studies ; Pulmonary Disease, Chronic Obstructive ; Walking/physiology ; Comorbidity ; Regression Analysis
Language	English
Publishing date	2023-10-10
Publishing country	England
Document type	Journal Article
ZDB-ID	1003348-8
ISSN	1532-3064 ; 0954-6111
ISSN (online)	1532-3064
ISSN	0954-6111
DOI	10.1016/j.rmed.2023.107424
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Article: Patients' acceptance of outcome and experience measurements during hospitalisation for COPD exacerbations: a CICERO Clinical Research Collaboration-European Lung Foundation online patient survey.

Gyselinck, Iwein / Ramakrishnan, Sanjay / Vermeersch, Kristina / Halner, Andreas / Pott, Hendrik / Dobbels, Fabienne / Coleman, Courtney / Collis, Philip / Watz, Henrik / Greulich, Timm / Franssen, Frits M E / Burgel, Pierre-Régis / Bafadhel, Mona / Janssens, Wim

ERJ open research

2023 Volume 9, Issue 4

Abstract: Background: The lack of standardised outcome assessments during hospitalisation and follow-up for acute COPD exacerbations has hampered scientific progress and clinical proficiency. The objective of the present study was to evaluate patients' acceptance ...

Abstract	Background: The lack of standardised outcome assessments during hospitalisation and follow-up for acute COPD exacerbations has hampered scientific progress and clinical proficiency. The objective of the present study was to evaluate patients' acceptance of selected outcome and experience measurements during hospitalisations for COPD exacerbations and follow-up. Methods: An online survey was held amongst COPD patients in France, Belgium, The Netherlands, Germany and the UK. The European Lung Foundation COPD Patient Advisory Group was involved in the conceptualisation, development and dissemination of the survey. The survey was complementary to a previously obtained expert consensus. We assessed patients' views and acceptance of selected patient-reported outcomes or experiences and corresponding measurement instruments (for dyspnoea, frequent productive cough, health status and hospitalisation experience), and of selected clinical investigations (blood draw, pulmonary function test, 6-min walk test, chest computed tomography, echocardiography). Findings: 200 patients completed the survey. All selected outcomes and experiences were deemed important, and acceptance of their methods of assessment was high. The modified Medical Research Council scale and a numerical rating scale to address dyspnoea, the COPD Assessment Test for quality of life and frequent productive cough, and the Hospital Consumer Assessment of Healthcare Providers and Systems for hospital experiences were the instruments preferred by patients. Consensus on importance of blood draw and spirometry was higher compared with the other investigations. Interpretation: The survey results endorse the use of the selected outcome and experience measurements during hospitalisations for COPD exacerbations. They can be used to optimise standardised and patient-centred care and facilitate multicentric data collection.
Language	English
Publishing date	2023-07-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2827830-6
ISSN	2312-0541
ISSN	2312-0541
DOI	10.1183/23120541.00148-2023
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Article ; Online: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial.

Gyselinck, Iwein / Liesenborghs, Laurens / Landeloos, Ewout / Belmans, Ann / Verbeke, Geert / Verhamme, Peter / Vos, Robin / Janssens, W

Trials

2021 Volume 22, Issue 1, Page(s) 126

Abstract: Background: The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 ... ...

Abstract	Background: The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods: DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician's discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion: The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration: EU Clinical trials register EudraCT Nb 2020-001614-38 . Registered on 22 April 2020.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Azithromycin/administration & dosage ; Azithromycin/adverse effects ; Belgium/epidemiology ; COVID-19/epidemiology ; COVID-19/virology ; Female ; Humans ; Hydroxychloroquine/therapeutic use ; Length of Stay ; Male ; Middle Aged ; Multicenter Studies as Topic ; Polymerase Chain Reaction ; Proof of Concept Study ; Randomized Controlled Trials as Topic ; SARS-CoV-2/genetics ; Standard of Care ; Treatment Outcome ; Young Adult ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH) ; Azithromycin (83905-01-5)
Language	English
Publishing date	2021-02-09
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-021-05033-x
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