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.
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
552
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
pulmonary embolism (PE)
Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
Time frame: 2 and a half months
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
Time frame: 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)
Time frame: 2 and a half months
invasive ventilation
Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation
Time frame: 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)
Time frame: 2 and a half months
death
incidence of death
Time frame: 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: 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
Time frame: 2 and a half months
treatments and interventions applied for COVID-19
Type of treatments and interventions applied for COVID-19,
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 and a half months
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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
...and 34 more locations