Myeloproliferative Neoplasms (MPN) and COVID-19

NCT ID: NCT04385160

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 552 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2022-08-31

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.

Conditions

Myeloproliferative Neoplasm; COVID

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: collaborator

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiziano Barbui, Prof

Role: STUDY_CHAIR

Fondazione per la Ricerca Ospedale di Bergamo

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

Florence, , Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

IRCCS Ospedale San Raffaele

Milan, , 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 ·

Wroclaw, , 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

Countries

United States; Bulgaria; Croatia; France; Germany; Italy; Poland; Spain; United Kingdom

Other Identifiers

FROM - O-MPN-COVID-2020

Identifier Type: -

Identifier Source: org_study_id