Myeloproliferative Neoplasms (MPN) and COVID-19 (MPN-COVID)

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.

Study Overview

• Status: Completed
• Conditions: COVID; Myeloproliferative Neoplasm

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.

• Study Type: Observational
• Enrollment (Actual): 552

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • National Specialised Hospital for Active Treatment of Hematological Diseases
• Croatia
  • Zagreb, Croatia
    • University hospital Dubrava-School of Medicine University of Zagreb
• France
  • Paris, France
    • Hôpital Saint-Louis
• Germany
  • Aachen, Germany
    • University Medical Center RWTH
  • Greifswald, Germany, 17475
    • University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care
  • Minden, Germany
    • University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center
  • Saale
    • Halle, Saale, Germany, 06112
      • University Hospital Halle, Department of Hematology/Oncology
• Italy
  • Alessandria, Italy, 15121
    • A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
  • Bergamo, Italy, 24127
    • ASST-Papa Giovanni XXIII
  • Bologna, Italy, 40138
    • Policlinico S.Orsola-Malpighi
  • Brescia, Italy, 25123
    • ASST-Spedali Civili
  • Florence, Italy, 50134
    • AOU Ospedale Careggi
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20132
    • Irccs Ospedale San Raffaele
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore Della Carità
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
  • Roma, Italy, 00168
    • Policlinico Universitario Fondazione Agostino Gemelli
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e Della Scienza di Torino
  • Verona, Italy, 37134
    • Ospedale Policlinico "G.B. Rossi" Borgo Roma
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo
  • Monza Brianza
    • Monza, Monza Brianza, Italy, 20900
      • Ospedale San Gerardo di Monza
• Poland
  • Wroclaw, Poland
    • Sobas Wroclaw Medical University ·
• Spain
  • Albacete, Spain
    • Servicio de Hematología Hospital General Universitario de Albacete
  • Alicante, Spain
    • Hospital General de Elche
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Girona, Spain
    • ICO Girona Hospital Josep Trueta Servei d'hematologia
  • Madrid, Spain
    • Hospital Ramon y Cajal
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Hospital Gregorio Marañón
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain
    • Hospital Moncloa
  • Madrid, Spain
    • FEA Hematología Hospital Universitario de Móstoles
  • Valencia, Spain
    • Hospital Clínico Universitario
  • Barcellona
    • Barcelona, Barcellona, Spain
      • Hospital Clinic De Barcelona
    • Barcelona, Barcellona, Spain
      • Hospital del Mar
  • Barcelona
    • Badalona, Barcelona, Spain
      • Institut Català d' Oncologia - Hospital Germans Trias i Pujol
    • Sant Joan Despí, Barcelona, Spain
      • ICO L'Hospitalet - Hospital Moisès Broggi
  • Madrid
    • Alcalá de Henares, Madrid, Spain
      • Hospital Universitario Príncipe de Asturias
  • Santa Cruz De Tenerife
    • Breña Alta, Santa Cruz De Tenerife, Spain
      • Hospital General de La Palma
• United Kingdom
  • London, United Kingdom
    • Guy's and St. Thomas' NHS Foundation Trust.
• United States
  • New York
    • New York, New York, United States, 10065
      • New York-Presbyterian/Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Myeloproliferative Neoplasm (Polycythemia Vera, Essential Polycythemia, Myelofibrosis) diagnosed with COVID-19 between 15 February 2020 and 15 February 2022

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary embolism (PE)	Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism	2 and a half months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatal or non fatal thrombotic event	Incidence of cases reporting at least one fatal or non fatal thrombotic event reported in therapy of MPN, , with particular focus to those occurred during hospitalization	2 and a half months
Continuous Positive Airway Pressure (CPAP)	Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)	2 and a half months
invasive ventilation	Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation	2 and a half months
admission in Intensive Care Unit (ICU)	Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)	2 and a half months
death	incidence of death	2 and a half months
treatments and interventions applied for MPN	Type of treatments and interventions applied for MPN during COVID-19 and any change reported in therapy of MPN, particularly including: Mortality rate by discontinuation of cytoreductive drugs; Mortality rate by time of exposure to cytoreductive drugs (before vs after Covid-19 pandemic); Mortality rate by cytoreductive drugs use and/or discontinuation and MPN type (MF, PV, ET, pre-PMF); Cause-specific mortality rate by cytoreductive drugs use and/or discontinuation	2 and a half months
treatments and interventions applied for COVID-19	Type of treatments and interventions applied for COVID-19,	2 and a half months
thrombotic events association to patients characteristic and treatments	Odds Ratios (ORs) of the outcome and 95% Confidence Intervals (CIs) associated with patients' characteristics and treatments	2 and a half months
Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment	incidence of death in phenotype subgroups and by cytoreductive categories of drug	2 and a half months
MPN progression rate	Incidence of evolution to leukemia, myelofirbrosis and/or second cancers MPN, evaluated by cytoreductive drugs and therapy administered for COVID-19 as terms of interaction	2 and a half months

Collaborators and Investigators

• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
• Collaborators: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Investigators: Study Chair: Tiziano Barbui, Prof, Fondazione per la Ricerca Ospedale di Bergamo

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: thrombosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Thrombosis; Myeloproliferative Disorders
• Other Study ID Numbers: FROM - O-MPN-COVID-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Each participant can visualize its own data on eCRF after the completion patient's electronic data form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No