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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385160
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : November 12, 2021
Sponsor:
Collaborator:
European Leukemia Net
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

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
Myeloproliferative Neoplasm COVID

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.

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





Primary Outcome Measures :
  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 Measures :
  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:

    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

  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385160


Contacts
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Contact: Arianna Masciulli, PharmD 0352678926 amasciulli@fondazionefrom.it
Contact: Alessandra Carobbio, BioStat acarobbio@fondazionefrom.it

Locations
Show Show 41 study locations
Sponsors and Collaborators
Fondazione per la Ricerca Ospedale Maggiore
European Leukemia Net
Investigators
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Study Chair: Tiziano Barbui, Prof Fondazione per la Ricerca Ospedale di Bergamo
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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    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Each participant can visualize its own data on eCRF after the completion patient's electronic data form.

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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:
thrombosis
Additional relevant MeSH terms:
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Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases