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.
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
Primary outcome:
1. pulmonary embolism (PE) (Time Frame - 2 and a half months):
Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
Secondary outcome:
1. 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. 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)
3. invasive ventilation (Time Frame - 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) (Time Frame - 2 and a half months):
Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)
5. death (Time Frame - 2 and a half months):
incidence of death
6. 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:
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 (Time Frame - 2 and a half months):
Type of treatments and interventions applied for COVID-19,
8. 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
9. 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
10. 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
Quelle: ClinicalTrials.gov
