Myeloproliferative Neoplasms (MPN) and COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Myeloproliferative Neoplasms (MPN) and COVID-19

Conditions
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Myeloproliferative Neoplasm, COVID

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombosis