Official Title
Myeloproliferative Neoplasms (MPN) and COVID-19
Brief Summary

An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

Detailed Description

This is an European multicenter observational study that will include around 550 MPN patients
with a confirmed diagnosis of Covid-19 will be followed for at least one month. Detailed
information on the clinical characteristics of these patients and their disease outcomes will
be retrospectively and prospectively collected in a specific eCRF, including MPN
characteristics, treatment and comorbidities pre-Covid-19, time of Covid-19 diagnosis,
drugs/device used for the treatment of Covid-19, any change in MPN therapy, antithrombotic
prophylaxis employed during the period of infection and - for hospitalised patients only -
key blood and laboratory parameters. A particular focus will be on exploring final outcomes
for patients in this study, most notably the incidence of fatal and non-fatal thrombotic
events. Statistical analyses will also be performed looking for any independent factors that
can significantly predict patient outcomes after Covid-19 diagnosis.

Ultimately, this project will provide important insights into disease severity and
progression in patients with MPN and Covid-19 and uncover the key clinical factors which
drive outcomes and mortality. Results may help clinicians better understand how patient
characteristics and management decisions can impact on disease trajectory when MPN and
Covid-19 collide.

Recruiting
Myeloproliferative Neoplasm
COVID
Eligibility Criteria

Inclusion Criteria:

- Age > 18 years

- Confirmed diagnosed of MPN according to WHO criteria

- Diagnosis of COVID-19 based by the positivity of oropharyngeal swab performed between
15 February 2020 up to 15 February 2022

- Signed informed consent

Exclusion Criteria:

- None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Bulgaria
Croatia
France
Germany
Italy
Poland
Spain
United Kingdom
United States
Locations

New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States

National Specialised Hospital for Active Treatment of Hematological Diseases
Sofia, Bulgaria

University hospital Dubrava-School of Medicine University of Zagreb
Zagreb, Croatia

Hopital Saint-Louis
Paris, France

University Hospital Halle, Department of Hematology/Oncology
Halle, Saale, Germany

University Medical Center RWTH
Aachen, Germany

University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care
Greifswald, Germany

University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center
Minden, Germany

Ospedale San Gerardo di Monza
Monza, Monza Brianza, Italy

A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
Alessandria, Italy

ASST-Papa Giovanni XXIII
Bergamo, Italy

Policlinico S.Orsola-Malpighi
Bologna, Italy

ASST-Spedali Civili
Brescia, Italy

AOU Ospedale Careggi
Firenze, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Italy

IRCCS Ospedale San Raffaele
Milano, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy

IRCCS Policlinico San Matteo
Pavia, Italy

Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy

Ospedale Policlinico "G.B. Rossi" Borgo Roma
Verona, Italy

Ospedale San Bortolo
Vicenza, Italy

Sobas Wroclaw Medical University ·
Wrocław, Poland

Hospital Clínic De Barcelona
Barcelona, Barcellona, Spain

Hospital del Mar
Barcelona, Barcellona, Spain

Institut Català d' Oncologia - Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain

ICO L'Hospitalet - Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain

Hospital Universitario Príncipe de Asturias
Alcalá De Henares, Madrid, Spain

Hospital General de La Palma
Breña Alta, Santa Cruz De Tenerife, Spain

Servicio de Hematología Hospital General Universitario de Albacete
Albacete, Spain

Hospital General de Elche
Alicante, Spain

Hospital Vall d'Hebron
Barcelona, Spain

Hospital Universitario de Burgos
Burgos, Spain

ICO Girona Hospital Josep Trueta Servei d'hematologia
Girona, Spain

FEA Hematología Hospital Universitario de Móstoles
Madrid, Spain

Hospital 12 de octubre
Madrid, Spain

Hospital Clínico San Carlos
Madrid, Spain

Hospital Gregorio Marañón
Madrid, Spain

Hospital Moncloa
Madrid, Spain

Hospital Ramón y Cajal
Madrid, Spain

Hospital Universitario Infanta Leonor
Madrid, Spain

Hospital Universitario La Paz
Madrid, Spain

Hospital Clínico Universitario
Valencia, Spain

Guy's and St. Thomas' NHS Foundation Trust.
London, United Kingdom

Contacts

Francesca Fenili
0352678926
ffenili@fondazionefrom.it

Alessandra Carobbio, BioStat
acarobbio@fondazionefrom.it

Tiziano Barbui, Prof, Study Chair
Fondazione per la Ricerca Ospedale di Bergamo

European Leukemia Net
NCT Number
Keywords
thrombosis
MeSH Terms
Neoplasms
Myeloproliferative Disorders