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Darko Antic; Natasa Milic; Thomas Chatzikonstantinou; Lydia Scarfò; Vladimir Otasevic; Nina Rajovic; David Allsup; Alejandro Alonso Cabrero; Martin Andres; Monica Baile Gonzales; Antonella Capasso; Rosa Collado; Raul Cordoba; Carolina Cuéllar-García; Juan Gonzalo Correa; Lorenzo De Paoli; Maria Rosaria De Paolis; Giovanni Del Poeta; Maria Dimou; Michael Doubek; Maria Efstathopoulou; Shaimaa El-Ashwah; Alicia Enrico; Blanca Espinet; Lucia Farina; Angela Ferrari; Myriam Foglietta; Alberto Lopez-Garcia; José A. García-Marco; Rocío García-Serra; Massimo Gentile; Eva Gimeno; Maria Gomes Silva; Odit Gutwein; Yervand K. Hakobyan; Yair Herishanu; José Ángel Hernández-Rivas; Tobias Herold; Gilad Itchaki; Ozren Jaksic; Ann Janssens; Оlga B. Kalashnikova; Elżbieta Kalicińska; Arnon P. Kater; Sabina Kersting; Maya Koren-Michowitz; Jorge Labrador Gomez; Deepesh Lad; Luca Laurenti; Alberto Fresa; Mark-David Levin; Carlota Mayor Bastida; Lara Malerba; Roberto Marasca; Monia Marchetti; Juan Marquet; Biljana Mihaljevic; Ivana Milosevic; Fatima Mirás; Marta Morawska; Marina Motta; Talha Munir; Roberta Murru; Raquel Nunes; Jacopo Olivieri; Miguel Arturo Pavlovsky; Inga Piskunova; Viola Maria Popov; Francesca Maria Quaglia; Giulia Quaresmini; Gianluigi Reda; Gian Matteo Rigolin; Amit Shrestha; Martin Šimkovič; Svetlana Smirnova; Martin Špaček; Paolo Sportoletti; Oana Stanca; Niki Stavroyianni; Doreen Te Raa; Kristina Tomic; Sanne Tonino; Livio Trentin; Ellen Der Spek; Michel Gelder; Marzia Varettoni; Andrea Visentin; Candida Vitale; Vojin Vukovic; Ewa Wasik-Szczepanek; Tomasz Wróbel; Lucrecia Yáñez San Segundo; Mohamed Yassin; Marta Coscia; Alessandro Rambaldi; Emili Montserrat; Robin Foà; Antonio Cuneo; Marc Carrier; Paolo Ghia; Kostas Stamatopoulos.
researchsquare; 2022.


Background: Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to COVID-19 related poor outcomes, including thrombosis and death, due to the advanced age, the presence of comorbidities, and the disease and treatment-related immune deficiency. In this retrospective multicenter study, conducted by ERIC, the European Research Initiative on CLL, we assessed the risk of thrombosis and bleeding in patients with CLL affected by severe COVID-19.Methods: The study included patients from 79 centers across 22 countries. Data collection was conducted between April and May 2021.Results: A total of 793 patients from 79 centers were included in the study with 593 being hospitalized (74.8%). Among these, 518 were defined as having severe COVID: 162 were admitted to the ICU while 356 received oxygen supplementation outside the ICU. Most patients (90%) were receiving thromboprophylaxis. During COVID-19 treatment, 8.8% developed a thromboembolic event, while 4.8% experienced bleeding. Thrombosis developed in 20.5% of patients who were not receiving thromboprophylaxis, but only in 8.1% of patients who were on thromboprophylaxis. Bleeding episodes were more frequent in patients receiving intermediate/therapeutic versus prophylactic doses of low-molecular-weight heparin (LWMH) (11.1% vs. 4.2%, respectively) and in elderly. In multivariate analysis, peak D-dimer level was a poor prognostic factor for thrombosis occurrence (OR=1.020, 95%CI 1.006‒1.033), while thromboprophylaxis use was protective (OR=0.194, 95%CI 0.061‒0.614). Age and LMWH intermediate/therapeutic dose administration were prognostic factors in multivariate model for bleeding (OR=1.055, 95%CI 1.013-1.103 and OR=2.490, 95%CI 1.044-5.935, respectively). Conclusions: Patients with CLL affected by severe COVID-19 are at a high risk of thrombosis if thromboprophylaxis is not used, but also at increased risk of bleeding under the LMWH intermediate/therapeutic dose administration.  

medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.04.08.22273602


ImportanceIn patients with hematologic malignancies, the immunogenicity of the standard 2-dose mRNA-1273 coronavirus disease 19 (COVID-19) vaccination schedule is often insufficient due to underlying disease and current or recent therapy. ObjectiveTo determine whether a 3rd mRNA-1273 vaccination raises antibody concentrations in immunocompromised hematology patients to levels obtained in healthy individuals after the standard 2-dose mRNA-1273 vaccination schedule. DesignProspective observational cohort study. SettingFour academic hospitals in the Netherlands. Participants584 evaluable immunocompromised hematology patients, all grouped in predefined cohorts spanning the spectrum of hematologic malignancies. ExposureOne additional vaccination with mRNA-1273 5 months after completion of the standard 2-dose mRNA-1273 vaccination schedule. Main Outcomes and MeasuresSerum IgG antibodies to spike subunit 1 (S1) antigens prior to and 4 weeks after each vaccination, and pseudovirus neutralization of wildtype, delta and omicron variants in a subgroup of patients. ResultsIn immunocompromised hematology patients, a 3rd mRNA-1273 vaccination led to median S1 IgG concentrations comparable to concentrations obtained by healthy individuals after the 2-dose mRNA-1273 schedule. The rise in S1 IgG concentration after the 3rd vaccination was most pronounced in patients with a recovering immune system, but potent responses were also observed in patients with persistent immunodeficiencies. Specifically, patients with myeloid malignancies or multiple myeloma, and recipients of autologous or allogeneic hematopoietic cell transplantation (HCT) reached median S1 IgG concentrations similar to those obtained by healthy individuals after a 2-dose schedule. Patients on or shortly after rituximab therapy, CD19-directed chimeric antigen receptor T cell therapy recipients, and chronic lymphocytic leukemia patients on ibrutinib were less or unresponsive to the 3rd vaccination. In the 27 patients who received cell therapy between the 2nd and 3rd vaccination, S1 antibodies were preserved, but a 3rd mRNA-1273 vaccination did not significantly enhance S1 IgG concentrations except for multiple myeloma patients receiving autologous HCT. A 3rd vaccination significantly improved neutralization capacity per antibody. Conclusions and RelevanceThe primary schedule for immunocompromised patients with hematologic malignancies should be supplemented with a delayed 3rd vaccination. B cell lymphoma patients and allogeneic HCT recipients need to be revaccinated after treatment or transplantation. Trial RegistrationEudraCT 2021-001072-41 Key pointsO_ST_ABSQuestionC_ST_ABSCan a 3rd mRNA-1273 vaccination improve COVID-19 antibody concentrations in immunocompromised hematology patients to levels similar to healthy adults after the standard 2-dose mRNA-1273 schedule? FindingsIn this prospective observational cohort study that included 584 immunocompromised hematology patients, a 3rd mRNA-1273 vaccination significantly improved SARS-CoV-2 antibody concentrations to levels not significantly different from those obtained by healthy individuals after the standard 2-dose mRNA-1273 vaccination schedule. Pseudovirus neutralization capacity per antibody of wild type virus and variants of concern also significantly improved. MeaningThe primary COVID-19 vaccination schedule for immunocompromised patients with hematologic malignancies should be supplemented with a delayed 3rd vaccination.

medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.04.04.22273314


Background: Severely immunocompromised patients are at risk for severe COVID-19. Benefit from convalescent plasma in these patients is suggested but data from randomised trials are lacking. The aim of this study is to determine efficacy of SARS-CoV-2 hyperimmune globulin (COVIG) in treatment of severely immunocompromised, hospitalised COVID-19 patients. Methods: In this randomised, controlled, double-blind, multicentre, phase 3 trial, severely immunocompromised patients who were hospitalised with symptomatic COVID-19 were randomly assigned (1:1) to receive 15 grams of COVIG or 15 grams of intravenous immunoglobulin without SARS-CoV-2 antibodies (IVIG, control). Patients included were solid organ transplant patients with three drugs from different immunosuppressive classes or patient with disease or treatment severely affecting B-cell function. Patients that required mechanical ventilation or high flow nasal oxygen were excluded. All investigators, research staff, and participants were masked to group allocation. The primary endpoint was occurrence of severe COVID-19 evaluated up until day 28 after treatment, defined as the need for mechanical ventilation, high-flow nasal oxygen, readmission for COVID-19 after hospital discharge or lack of clinical improvement on day seven or later. This trial is registered with Netherlands Trial Register (NL9436). Findings: From April, 2021, to July, 2021, 18 participants were enrolled at three sites in the Netherlands; 18 patients were analysed. Recruitment was halted prematurely when casirivimab/imdevimab became the recommended therapy in the Dutch COVID-19 treatment guideline for seronegative, hospitalised COVID-19 patients. Median age was 58 years and all but two were negative for SARS-CoV-2 spike IgG at baseline. Severe COVID-19 was observed in two out of ten (20%) patients treated with COVIG compared to seven of eight (88%) in the IVIG control group (p = 0.015, Fisher's exact test). Interpretation: COVIG reduced the incidence of severe COVID-19 in severely immunocompromised patients, hospitalised with COVID-19. COVIG may be a valuable treatment in this patient group and can be used when no monoclonal antibody therapies are available. Funding: The Netherlands Organisation for Health Research and Development, Sanquin Blood Supply Foundation.