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

April 4, 2022 updated by: Fondazione per la Ricerca Ospedale Maggiore
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

Recruiting

Conditions

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 (Anticipated)

552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Recruiting
        • National Specialised Hospital for Active Treatment of Hematological Diseases
        • Contact:
        • Principal Investigator:
          • Margarita Guenova
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • University hospital Dubrava-School of Medicine University of Zagreb
        • Contact:
        • Principal Investigator:
          • Rajko Kusec, MD
  • France
      • Paris, France
        • Recruiting
        • Hôpital Saint-Louis
        • Principal Investigator:
          • Jean-Jacques Kiladjian
        • Contact:
  • Germany
      • Aachen, Germany
        • Recruiting
        • University Medical Center RWTH
        • Contact:
        • Principal Investigator:
          • Steffen Koschmieder
      • Greifswald, Germany, 17475
        • Recruiting
        • University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care
        • Contact:
        • Principal Investigator:
          • Florian H. Heidel
      • Minden, Germany
        • Recruiting
        • University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center
        • Contact:
        • Principal Investigator:
          • Martin Griesshammer
        • Sub-Investigator:
          • Kai Wille
    • Saale
      • Halle, Saale, Germany, 06112
        • Suspended
        • University Hospital Halle, Department of Hematology/Oncology
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
        • Contact:
        • Principal Investigator:
          • Monia Marchetti
      • Bergamo, Italy, 24127
      • Bologna, Italy, 40138
      • Brescia, Italy, 25123
      • Firenze, Italy, 50134
        • Recruiting
        • AOU Ospedale Careggi
        • Contact:
        • Principal Investigator:
          • Paola Guglielmelli
        • Sub-Investigator:
          • Alessandro M Vannucchi
      • Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Principal Investigator:
          • Fabio Ciceri
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Francesca Lunghi
      • Milano, Italy, 20122
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità
        • Principal Investigator:
          • Andrea Patriarca
        • Contact:
      • Pavia, Italy, 27100
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Universitario Fondazione Agostino Gemelli
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valerio De Stefano
        • Sub-Investigator:
          • Elena Rossi
        • Sub-Investigator:
          • Silvia Betti
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino
        • Contact:
        • Principal Investigator:
          • Giulia Benevolo
      • Verona, Italy, 37134
        • Recruiting
        • Ospedale Policlinico "G.B. Rossi" Borgo Roma
        • Contact:
        • Sub-Investigator:
          • Luigi Scaffidi
        • Sub-Investigator:
          • Emilia Florea
      • Vicenza, Italy, 36100
        • Recruiting
        • Ospedale San Bortolo
        • Contact:
        • Principal Investigator:
          • Giuseppe Carli
        • Sub-Investigator:
          • Ilaria Nichele
    • Monza Brianza
      • Monza, Monza Brianza, Italy, 20900
        • Recruiting
        • Ospedale San Gerardo di Monza
        • Principal Investigator:
          • Elena Elli
        • Contact:
        • Sub-Investigator:
          • Fabrizio Cavalca
  • Poland
      • Wrocław, Poland
        • Recruiting
        • Sobas Wroclaw Medical University ·
        • Contact:
        • Principal Investigator:
          • Marta Anna Sobas
  • Spain
      • Albacete, Spain
        • Recruiting
        • Servicio de Hematología Hospital General Universitario de Albacete
        • Contact:
        • Principal Investigator:
          • Alberto Marín Sánchez
      • Alicante, Spain
        • Recruiting
        • Hospital General de Elche
        • Contact:
        • Principal Investigator:
          • Emma López Abadía
      • Barcelona, Spain
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Laura Fox
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
        • Principal Investigator:
          • Beatriz Cuevas
      • Girona, Spain
        • Recruiting
        • ICO Girona Hospital Josep Trueta Servei d'hematologia
        • Contact:
        • Principal Investigator:
          • Anna Angona
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Mercedes Gasior Kabat
      • Madrid, Spain
        • Recruiting
        • Hospital Gregorio Marañon
        • Contact:
        • Principal Investigator:
          • Santiago Osorio
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Principal Investigator:
          • Maria Ángeles Foncillas
      • Madrid, Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • Valentin Garcia Gutierrez
      • Madrid, Spain
      • Madrid, Spain
        • Recruiting
        • FEA Hematología Hospital Universitario de Móstoles
        • Contact:
        • Principal Investigator:
          • Keina Susana Quiroz Cervantes
      • Madrid, Spain
        • Recruiting
        • Hospital Moncloa
        • Contact:
        • Principal Investigator:
          • Begoña Navas Elorza
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario
        • Principal Investigator:
          • Juan Carlos Hernández Boluda
        • Contact:
    • Barcellona
      • Barcelona, Barcellona, Spain
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
        • Principal Investigator:
          • Alberto Alvarez Larran
      • Barcelona, Barcellona, Spain
        • Recruiting
        • Hospital Del Mar
        • Contact:
        • Principal Investigator:
          • Marcio Miguel Andrade Campos
    • Barcelona
      • Badalona, Barcelona, Spain
        • Recruiting
        • Institut Català d' Oncologia - Hospital Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Blanca Xicoy Cirici
      • Sant Joan Despí, Barcelona, Spain
        • Recruiting
        • ICO L'Hospitalet - Hospital Moisès Broggi
        • Contact:
        • Principal Investigator:
          • Miguel Sagüés Serrano
    • Madrid
      • Alcalá De Henares, Madrid, Spain
        • Recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
        • Principal Investigator:
          • Elena Magro Mazo
    • Santa Cruz De Tenerife
      • Breña Alta, Santa Cruz De Tenerife, Spain
        • Not yet recruiting
        • Hospital General de La Palma
        • Contact:
        • Principal Investigator:
          • María Tapia Torres
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Guy's and St. Thomas' NHS Foundation Trust.
        • Contact:
        • Principal Investigator:
          • Claire Harrison
  • United States
    • New York
      • New York, New York, United States, 10065
        • Suspended
        • New York-Presbyterian/Weill Cornell Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Time Frame: 2 and a half months
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
Time Frame: 2 and a half months
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)
Time Frame: 2 and a half months
Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)
2 and a half months
invasive ventilation
Time Frame: 2 and a half months
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)
Time Frame: 2 and a half months
Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)
2 and a half months
death
Time Frame: 2 and a half months
incidence of death
2 and a half months
treatments and interventions applied for MPN
Time Frame: 2 and a half months

Type of treatments and interventions applied for MPN during COVID-19 and any change reported in therapy of MPN, particularly including:

  1. Mortality rate by discontinuation of cytoreductive drugs
  2. Mortality rate by time of exposure to cytoreductive drugs (before vs after Covid-19 pandemic)
  3. Mortality rate by cytoreductive drugs use and/or discontinuation and MPN type (MF, PV, ET, pre-PMF)
  4. Cause-specific mortality rate by cytoreductive drugs use and/or discontinuation
2 and a half months
treatments and interventions applied for COVID-19
Time Frame: 2 and a half months
Type of treatments and interventions applied for COVID-19,
2 and a half months
thrombotic events association to patients characteristic and treatments
Time Frame: 2 and a half months
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
Time Frame: 2 and a half months
incidence of death in phenotype subgroups and by cytoreductive categories of drug
2 and a half months
MPN progression rate
Time Frame: 2 and a half months
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

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione per la Ricerca Ospedale Maggiore

Collaborators

European Leukemia Net

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Actual)

February 15, 2022

Study Completion (Anticipated)

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 (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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