Myeloproliferative NeoplasmMPN-COVIDNCT04385160
Myeloproliferative Neoplasms (MPN) and COVID-19
An observational study of Myeloproliferative Neoplasm and COVID, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 44 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, COVID
- How many people
- 552 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 13 May 2020to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Myeloproliferative Neoplasm (Polycythemia Vera, Essential Polycythemia, Myelofibrosis) diagnosed with COVID-19 between 15 February 2020 and 15 February 2022
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
Spain20 sites
Servicio de Hematología Hospital General Universitario de Albacete
Albacete
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital General de Elche
Alicante
Institut Català d' Oncologia - Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Clínic De Barcelona
Barcelona, Barcellona
Hospital del Mar
Barcelona, Barcellona
Hospital Vall d'Hebron
Barcelona
Hospital General de La Palma
Breña Alta, Santa Cruz De Tenerife
Hospital Universitario de Burgos
Burgos
ICO Girona Hospital Josep Trueta Servei d'hematologia
Girona
FEA Hematología Hospital Universitario de Móstoles
Madrid
Hospital 12 de octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Gregorio Marañón
Madrid
Hospital Moncloa
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
ICO L'Hospitalet - Hospital Moisès Broggi
Sant Joan Despí, Barcelona
Hospital Clínico Universitario
Valencia
Italy14 sites
A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
Alessandria, 15121
ASST-Papa Giovanni XXIII
Bergamo, 24127
Policlinico S.Orsola-Malpighi
Bologna, 40138
ASST-Spedali Civili
Brescia, 25123
AOU Ospedale Careggi
Florence, 50134
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
IRCCS Ospedale San Raffaele
Milan, 20132
Ospedale San Gerardo di Monza
Monza, Monza Brianza, 20900
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
IRCCS Policlinico San Matteo
Pavia, 27100
Policlinico Universitario Fondazione Agostino Gemelli
Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126
Ospedale Policlinico "G.B. Rossi" Borgo Roma
Verona, 37134
Ospedale San Bortolo
Vicenza, 36100
Germany4 sites
University Medical Center RWTH
Aachen
University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care
Greifswald, 17475
University Hospital Halle, Department of Hematology/Oncology
Halle, Saale, 06112
University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center
Minden
United States1 site
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Bulgaria1 site
National Specialised Hospital for Active Treatment of Hematological Diseases
Sofia
Croatia1 site
University hospital Dubrava-School of Medicine University of Zagreb
Zagreb
United Kingdom1 site
Guy's and St. Thomas' NHS Foundation Trust.
London
About this study
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.
Read the 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.
- Conditions
- Myeloproliferative Neoplasm, COVID
- Keywords
- thrombosis
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary embolism (PE)
Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
Measured: 2 and a half months
Secondary outcomes (10)
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
Measured: 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)
Measured: 2 and a half months
invasive ventilation
Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation
Measured: 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)
Measured: 2 and a half months
death
incidence of death
Measured: 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
Measured: 2 and a half months
treatments and interventions applied for COVID-19
Type of treatments and interventions applied for COVID-19,
Measured: 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
Measured: 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
Measured: 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
Measured: 2 and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start13 May 2020
- Primary completion15 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Responsible party
- Sponsor
- Investigators
- Tiziano Barbui, Prof, Study chair, Fondazione per la Ricerca Ospedale di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385160
- Sponsor's protocol ID
- FROM - O-MPN-COVID-2020
- Acronym
- MPN-COVID
- Status last verified
- Sep 2025
- First submitted
- 11 May 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each participant can visualize its own data on eCRF after the completion patient's electronic data form.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloproliferative Neoplasms (MPN) and COVID-19
- ClinicalTrials.gov ID
- NCT04385160
- Acronym / sponsor ID
- MPN-COVID / FROM - O-MPN-COVID-2020
- Conditions
- Myeloproliferative Neoplasm, COVID
- Keywords
- thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Study start
- 13 May 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Myeloproliferative Neoplasm (Polycythemia Vera, Essential Polycythemia, Myelofibrosis) diagnosed with COVID-19 between 15 February 2020 and 15 February 2022
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pulmonary embolism (PE)
Time frame: 2 and a half months
Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
10 secondary outcomes
fatal or non fatal thrombotic event
Time frame: 2 and a half months
Continuous Positive Airway Pressure (CPAP)
Time frame: 2 and a half months
invasive ventilation
Time frame: 2 and a half months
admission in Intensive Care Unit (ICU)
Time frame: 2 and a half months
death
Time frame: 2 and a half months
treatments and interventions applied for MPN
Time frame: 2 and a half months
treatments and interventions applied for COVID-19
Time frame: 2 and a half months
thrombotic events association to patients characteristic and treatments
Time frame: 2 and a half months
Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment
Time frame: 2 and a half months
MPN progression rate
Time frame: 2 and a half months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. Each participant can visualize its own data on eCRF after the completion patient's electronic data form.
Related trials for Myeloproliferative Neoplasm
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RecruitingPhase 2
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Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziano Barbui, Prof study chair
Fondazione per la Ricerca Ospedale di Bergamo
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm and COVID, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 44 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, Italy, Germany, United States, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary embolism (PE) (time frame: 2 and a half months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.