5 results on '"Verschelden, Gil"'
Search Results
2. Plasma zinc status and hyperinflammatory syndrome in hospitalized COVID-19 patients: An observational study.
- Author
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Verschelden G, Noeparast M, Noparast M, Goossens MC, Lauwers M, Cotton F, Michel C, Goyvaerts C, and Hites M
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- Aged, COVID-19 blood, Cytokine Release Syndrome blood, Female, Hospitalization, Humans, Male, Middle Aged, Prospective Studies, Zinc physiology, COVID-19 complications, Cytokine Release Syndrome etiology, SARS-CoV-2, Zinc blood
- Abstract
Zinc deficiency is associated with impaired antiviral response, cytokine releasing syndrome (CRS), and acute respiratory distress syndrome. Notably, similar complications are being observed during severe SARS-CoV-2 infection. We conducted a prospective, single-center, observational study in a tertiary university hospital (CUB-Hôpital Erasme, Brussels) to address the zinc status, the association between the plasma zinc concentration, development of CRS, and the clinical outcomes in PCR-confirmed and hospitalized COVID-19 patients. One hundred and thirty-nine eligible patients were included between May 2020 and November 2020 (median age of 65 years [IQR = 54, 77]). Our cohort's median plasma zinc concentration was 57 µg/dL (interquartile range [IQR] = 45, 67) compared to 74 µg/dL (IQR = 64, 84) in the retrospective non-COVID-19 control group (N = 1513; p < 0.001). Markedly, the absolute majority of COVID-19 patients (96%) were zinc deficient (<80 µg/dL). The median zinc concentration was lower in patients with CRS compared to those without CRS (-5 µg/dL; 95% CI = -10.5, 0.051; p = 0.048). Among the tested outcomes, zinc concentration is significantly correlated with only the length of hospital stay (rho = -0.19; p = 0.022), but not with mortality or morbidity. As such, our findings do not support the role of zinc as a robust prognostic marker among hospitalized COVID-19 patients who in our cohort presented a high prevalence of zinc deficiency. It might be more beneficial to explore the role of zinc as a biomarker for assessing the risk of developing a tissue-damaging CRS and predicting outcomes in patients diagnosed with COVID-19 at the early stage of the disease., (Copyright © 2021 Elsevier B.V. All rights reserved.)
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- 2021
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3. Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.
- Author
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Declercq, Jozefien, Van Damme, Karel F A, De Leeuw, Elisabeth, Maes, Bastiaan, Bosteels, Cedric, Tavernier, Simon J, De Buyser, Stefanie, Colman, Roos, Hites, Maya, Verschelden, Gil, Fivez, Tom, Moerman, Filip, Demedts, Ingel K, Dauby, Nicolas, De Schryver, Nicolas, Govaerts, Elke, Vandecasteele, Stefaan J, Van Laethem, Johan, Anguille, Sebastien, and van der Hilst, Jeroen
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CYTOKINE release syndrome ,COVID-19 ,INTERLEUKIN-1 ,HOSPITAL admission & discharge ,OXYGEN therapy ,LYMPHOPENIA - Abstract
Infections with SARS-CoV-2 continue to cause significant morbidity and mortality. Interleukin (IL)-1 and IL-6 blockade have been proposed as therapeutic strategies in COVID-19, but study outcomes have been conflicting. We sought to study whether blockade of the IL-6 or IL-1 pathway shortened the time to clinical improvement in patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome. We did a prospective, multicentre, open-label, randomised, controlled trial, in hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium. Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO 2 :FiO 2) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 μg/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 μg/L, which had been increasing over the previous 24 h, or lymphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 μg/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL). The COV-AID trial has a 2 × 2 factorial design to evaluate IL-1 blockade versus no IL-1 blockade and IL-6 blockade versus no IL-6 blockade. Patients were randomly assigned by means of permuted block randomisation with varying block size and stratification by centre. In a first randomisation, patients were assigned to receive subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade (1:2). In a second randomisation step, patients were allocated to receive a single dose of siltuximab (11 mg/kg) intravenously, or a single dose of tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade (1:1:1). The primary outcome was the time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive. The primary and supportive efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in the safety population. This study is registered online with ClinicalTrials.gov (NCT04330638) and EudraCT (2020-001500-41) and is complete. Between April 4, and Dec 6, 2020, 342 patients were randomly assigned to IL-1 blockade (n=112) or no IL-1 blockade (n=230) and simultaneously randomly assigned to IL-6 blockade (n=227; 114 for tocilizumab and 113 for siltuximab) or no IL-6 blockade (n=115). Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54–73), and median Systematic Organ Failure Assessment (SOFA) score at randomisation was 3 (2–4). All 342 patients were included in the primary intention-to-treat analysis. The estimated median time to clinical improvement was 12 days (95% CI 10–16) in the IL-1 blockade group versus 12 days (10–15) in the no IL-1 blockade group (hazard ratio [HR] 0·94 [95% CI 0·73–1·21]). For the IL-6 blockade group, the estimated median time to clinical improvement was 11 days (95% CI 10–16) versus 12 days (11–16) in the no IL-6 blockade group (HR 1·00 [0·78–1·29]). 55 patients died during the study, but no evidence for differences in mortality between treatment groups was found. The incidence of serious adverse events and serious infections was similar across study groups. Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk. Belgian Health Care Knowledge Center and VIB Grand Challenges program. [ABSTRACT FROM AUTHOR]
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- 2021
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4. Presumed Urinary Tract Infection in Patients Admitted with COVID-19: Are We Treating Too Much?
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Van Laethem, Johan, Wuyts, Stephanie C. M., Pierreux, Jan, Seyler, Lucie, Verschelden, Gil, Depondt, Thibault, Meuwissen, Annelies, Lacor, Patrick, Piérard, Denis, and Allard, Sabine D.
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URINARY tract infections ,COVID-19 ,DRUGS ,COMMUNICABLE diseases ,DRUG prescribing - Abstract
Despite the low rates of bacterial co-/superinfections in COVID-19 patients, antimicrobial drug use has been liberal since the start of the COVID-19 pandemic. Due to the low specificity of markers of bacterial co-/superinfection in the COVID-19 setting, overdiagnosis and antimicrobial overprescription have become widespread. A quantitative and qualitative evaluation of urinary tract infection (UTI) diagnoses and antimicrobial drug prescriptions for UTI diagnoses was performed in patients admitted to the COVID-19 ward of a university hospital between 17 March and 2 November 2020. A team of infectious disease specialists performed an appropriateness evaluation for every diagnosis of UTI and every antimicrobial drug prescription covering a UTI. A driver analysis was performed to identify factors increasing the odds of UTI (over)diagnosis. A total of 622 patients were included. UTI was present in 13% of included admissions, and in 12%, antimicrobials were initiated for a UTI diagnosis (0.71 daily defined doses (DDDs)/admission; 22% were scored as 'appropriate'). An evaluation of UTI diagnoses by ID specialists revealed that of the 79 UTI diagnoses, 61% were classified as probable overdiagnosis related to the COVID-19 hospitalization. The following factors were associated with UTI overdiagnosis: physicians who are unfamiliar working in an internal medicine ward, urinary incontinence, mechanical ventilation and female sex. Antimicrobial stewardship teams should focus on diagnostic stewardship of UTIs, as UTI overdiagnosis seems to be highly prevalent in admitted COVID-19 patients. [ABSTRACT FROM AUTHOR]
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- 2021
- Full Text
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5. Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial
- Author
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Benoit Misset, Hans Slabbynck, Ursula Smole, Linos Vandekerckhove, Nicolas Dauby, Helena Catharine Aegerter, Nicolas De Schryver, Jozefien Declercq, Catherine Legrand, Levi Hoste, Gil Verschelden, Fre Bauters, Xavier Wittebole, Bastiaan Maes, Eva Van Braeckel, Sébastien Anguille, Catherine Van Der Straeten, Marc Buyse, Sylvie Rottey, Tom Fivez, Dieter Stevens, Stefaan J. Vandecasteele, Maya Hites, Elke Govaerts, I Peene, Karel Van Damme, Simon Tavernier, Frank Hulstaert, Roos Colman, Stefanie De Buyser, Elisabeth De Leeuw, Jeroen Van der Hilst, Filip Moerman, Fabienne Liénart, Leen J M Seys, Leslie Naesens, Filomeen Haerynck, Ingel K. Demedts, Cedric Bosteels, Victor Bosteels, Pieter Depuydt, Johan Van Laethem, Bart N. Lambrecht, Internal Medicine, Supporting clinical sciences, Faculty of Medicine and Pharmacy, UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (SLuc) Service de soins intensifs, UCL - SSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles, Van Laethem, Johan/0000-0002-2490-216X, Hoste, Levi/0000-0001-9733-1049, Naesens, Leslie/0000-0003-1715-0665, Declercq , Jozefien, Van Damme, Karel F. A., De Leeuw, Elisabeth, Maes, Bastiaan, Bosteels, Cedric, Tavernier, Simon J., De Buyser, Stefanie, Colman, Roos, Hites, Maya, Verschelden, Gil, Fivez, Tom, Moerman , Filip, Demedts, Ingel K., Dauby, Nicolas, De Schryver, Nicolas, Govaerts , Elke, Vandecasteele, Stefaan J., Van Laethem, Johan, Anguille, Sebastien, VAN DER HILST, Jeroen, Misset, Benoit, Slabbynck, Hans, Wittebole, Xavier, Lienart, Fabienne, LEGRAND, Catherine, BUYSE, Marc, Stevens, Dieter, Bauters, Fre, Seys, Leen J. M., Aegerter, Helena, Smole, Ursula, Bosteels, Victor, Hoste , Levi, Naesens, Leslie, Haerynck, Filomeen, Vandekerckhove, Linos, Depuydt, Pieter, van Braeckel, Eva, Rottey, Sylvie, Peene, Isabelle, Van Der Straeten, Catherine, Hulstaert, Frank, and Lambrecht, Bart N.
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Male ,Pulmonary and Respiratory Medicine ,Population ,Antibodies, Monoclonal, Humanized ,law.invention ,Belgium ,Randomized controlled trial ,law ,Fraction of inspired oxygen ,medicine ,Humans ,Prospective Studies ,Hypoxia ,education ,Aged ,education.field_of_study ,Interleukin-6 ,SARS-CoV-2 ,business.industry ,Comment ,Hazard ratio ,COVID-19 ,Antibodies, Monoclonal ,Middle Aged ,medicine.disease ,COVID-19 Drug Treatment ,Blockade ,Oxygen ,Cytokine release syndrome ,Treatment Outcome ,Respiratory failure ,Anesthesia ,Ferritins ,Female ,SOFA score ,Human medicine ,Cytokine Release Syndrome ,Respiratory Insufficiency ,business ,Interleukin-1 - Abstract
Background Infections with SARS-CoV-2 continue to cause significant morbidity and mortality. Interleukin (IL)-1 and IL-6 blockade have been proposed as therapeutic strategies in COVID-19, but study outcomes have been conflicting. We sought to study whether blockade of the IL-6 or IL-1 pathway shortened the time to clinical improvement in patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome. Methods We did a prospective, multicentre, open-label, randomised, controlled trial, in hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium. Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2:FiO(2)) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 mu g/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 mu g/L, which had been increasing over the previous 24 h, or lyrnphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 mu g/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL). The COV-AID trial has a 2 x 2 factorial design to evaluate IL-1 blockade versus no IL-1 blockade and IL-6 blockade versus no IL-6 blockade. Patients were randomly assigned by means of permuted block randomisation with varying block size and stratification by centre. In a first randomisation, patients were assigned to receive subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade (1:2). In a second randomisation step, patients were allocated to receive a single dose of siltuximab (11 mg/kg) intravenously, or a single dose of tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade (1:1:1). The primary outcome was the time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive. The primary and supportive efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in the safety population. This study is registered online with ClinicalTrials.gov (NCT04330638) and EudraCT (2020-001500-41) and is complete. Findings Between April 4, and Dec 6,2020,342 patients were randomly assigned to IL-1 blockade n=112) or no IL-1 blockade (n=230) and simultaneously randomly assigned to IL-6 blockade (n=227; 114 for tocilizumab and 113 for siltuximab) or no IL-6 blockade (n=115). Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54-73), and median Systematic Organ Failure Assessment (SOFA) score at randomisation was 3 (2-4). All 342 patients were included in the primary intention-to-treat analysis. The estimated median time to clinical improvement was 12 days (95% CI 10-16) in the IL-1 blockade group versus 12 days (10-15) in the no IL-1 blockade group (hazard ratio [HR] 0.94 [95% CI 0.73-1.21]). For the IL-6 blockade group, the estimated median time to clinical improvement was 11 days (95% CI 10-16) versus 12 days (11-16) in the no IL-6 blockade group (HR 1.00[0-78-1-29]). 55 patients died during the study, but no evidence for differences in mortality between treatment groups was found. The incidence of serious adverse events and serious infections was similar across study groups. Interpretation Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk. Copyright (C) 2021 Elsevier Ltd. All rights reserved. Belgian Health Care Knowledge Center; VIB Grand Challenges program The authors acknowledge professional support and committed efforts from various organisations and individuals involved in this trial and thank all trial participants and clinicians involved in patient recruitment at the different participating sites. This study was funded by KCE, and KCE was involved in various aspects of the study design, management, and execution (Nelle Stocquart, Jillian Harrison). The VIB Grand Challenges Program (Sofie Bekaert) funded measurements of cytokines and the Ghent University Special Research Fund (BOF) supported the clinical follow-up of patients at Ghent University Hospital (UZ Ghent). The clinical trial team of the Department of Respiratory Medicine at UZ Ghent (Stefanie Vermeersch, Benedicte Demeyere, Anja Delporte) were involved in protocol development, amendment filing, and eCRF construction. The Health Innovation and Research Institute of UZ Ghent was involved in eCRF design, protocol design, ethical committee reporting, drug dispensing, trial monitoring, data cleaning, and sponsor site management (Charlotte Clauwaert, Dries Loncke, Hanife Kokur, Lieselot Van Landuyt, Joke Tommelein, Hélène De Naeyer). The hospital pharmacy of UZ Ghent dispensed drugs to all study sites (Els Kestens). Team members of the Primary Immune Deficiency laboratory (Karlien Claes, Veronique Debacker, Lisa Roels, Zara Declercq) handled samples from all study sites. The authors acknowledge the insights of the data safety monitoring board (Drs Renaat Peleman, Geert Leroux-Roels, Steven Callens, Frank Vermassen, Piet Hoebeke, Karim Vermaelen, A Dupont, Tomasz Burzykowski, and Marnik Vuylsteke under the chairmanship of SR).
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- 2021
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