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

Sponsor
Fondazione per la Ricerca Ospedale Maggiore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04385160
Collaborator
European Leukemia Net (Other)
552
44
27.6
12.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    552 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Myeloproliferative Neoplasms (MPN) and COVID-19
    Actual Study Start Date :
    May 13, 2020
    Actual Primary Completion Date :
    Feb 15, 2022
    Anticipated Study Completion Date :
    Aug 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. pulmonary embolism (PE) [2 and a half months]

      Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism

    Secondary Outcome Measures

    1. fatal or non fatal thrombotic event [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. Continuous Positive Airway Pressure (CPAP) [2 and a half months]

      Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)

    3. invasive ventilation [2 and a half months]

      Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation

    4. admission in Intensive Care Unit (ICU) [2 and a half months]

      Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)

    5. death [2 and a half months]

      incidence of death

    6. treatments and interventions applied for MPN [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: 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

    7. treatments and interventions applied for COVID-19 [2 and a half months]

      Type of treatments and interventions applied for COVID-19,

    8. thrombotic events association to patients characteristic and treatments [2 and a half months]

      Odds Ratios (ORs) of the outcome and 95% Confidence Intervals (CIs) associated with patients' characteristics and treatments

    9. Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment [2 and a half months]

      incidence of death in phenotype subgroups and by cytoreductive categories of drug

    10. MPN progression rate [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York-Presbyterian/Weill Cornell Medical Center New York New York United States 10065
    2 National Specialised Hospital for Active Treatment of Hematological Diseases Sofia Bulgaria
    3 University hospital Dubrava-School of Medicine University of Zagreb Zagreb Croatia
    4 Hopital Saint-Louis Paris France
    5 University Hospital Halle, Department of Hematology/Oncology Halle Saale Germany 06112
    6 University Medical Center RWTH Aachen Germany
    7 University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care Greifswald Germany 17475
    8 University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center Minden Germany
    9 Ospedale San Gerardo di Monza Monza Monza Brianza Italy 20900
    10 A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria Alessandria Italy 15121
    11 ASST-Papa Giovanni XXIII Bergamo Italy 24127
    12 Policlinico S.Orsola-Malpighi Bologna Italy 40138
    13 ASST-Spedali Civili Brescia Italy 25123
    14 AOU Ospedale Careggi Firenze Italy 50134
    15 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Italy 20122
    16 IRCCS Ospedale San Raffaele Milano Italy 20132
    17 Azienda Ospedaliero Universitaria Maggiore della Carità Novara Italy 28100
    18 IRCCS Policlinico San Matteo Pavia Italy 27100
    19 Policlinico Universitario Fondazione Agostino Gemelli Roma Italy 00168
    20 A.O.U. Città della Salute e della Scienza di Torino Torino Italy 10126
    21 Ospedale Policlinico "G.B. Rossi" Borgo Roma Verona Italy 37134
    22 Ospedale San Bortolo Vicenza Italy 36100
    23 Sobas Wroclaw Medical University · Wrocław Poland
    24 Hospital Clínic De Barcelona Barcelona Barcellona Spain
    25 Hospital del Mar Barcelona Barcellona Spain
    26 Institut Català d' Oncologia - Hospital Germans Trias i Pujol Badalona Barcelona Spain
    27 ICO L'Hospitalet - Hospital Moisès Broggi Sant Joan Despí Barcelona Spain
    28 Hospital Universitario Príncipe de Asturias Alcalá De Henares Madrid Spain
    29 Hospital General de La Palma Breña Alta Santa Cruz De Tenerife Spain
    30 Servicio de Hematología Hospital General Universitario de Albacete Albacete Spain
    31 Hospital General de Elche Alicante Spain
    32 Hospital Vall d'Hebron Barcelona Spain
    33 Hospital Universitario de Burgos Burgos Spain
    34 ICO Girona Hospital Josep Trueta Servei d'hematologia Girona Spain
    35 FEA Hematología Hospital Universitario de Móstoles Madrid Spain
    36 Hospital 12 de octubre Madrid Spain
    37 Hospital Clínico San Carlos Madrid Spain
    38 Hospital Gregorio Marañón Madrid Spain
    39 Hospital Moncloa Madrid Spain
    40 Hospital Ramón y Cajal Madrid Spain
    41 Hospital Universitario Infanta Leonor Madrid Spain
    42 Hospital Universitario La Paz Madrid Spain
    43 Hospital Clínico Universitario Valencia Spain
    44 Guy's and St. Thomas' NHS Foundation Trust. London United Kingdom

    Sponsors and Collaborators

    • Fondazione per la Ricerca Ospedale Maggiore
    • European Leukemia Net

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione per la Ricerca Ospedale Maggiore
    ClinicalTrials.gov Identifier:
    NCT04385160
    Other Study ID Numbers:
    • FROM - O-MPN-COVID-2020
    First Posted:
    May 12, 2020
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione per la Ricerca Ospedale Maggiore
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022