Clinical trial NCT04385160: Myeloproliferative Neoplasms (MPN) and COVID-19
Official title: Myeloproliferative Neoplasms (MPN) and COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myeloproliferative Neoplasm
COVID
Keywords: thrombosis
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
Collaborators: name: European Leukemia Net
First posted: 2020-05-12
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility 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

Primary outcomes:
measure: pulmonary embolism (PE)
timeFrame: 2 and a half months
Secondary outcomes:
measure: fatal or non fatal thrombotic event
timeFrame: 2 and a half months
measure: Continuous Positive Airway Pressure (CPAP)
timeFrame: 2 and a half months
measure: invasive ventilation
timeFrame: 2 and a half months
measure: admission in Intensive Care Unit (ICU)
timeFrame: 2 and a half months
measure: death
timeFrame: 2 and a half months
measure: treatments and interventions applied for MPN
timeFrame: 2 and a half months
measure: treatments and interventions applied for COVID-19
timeFrame: 2 and a half months
measure: thrombotic events association to patients characteristic and treatments
timeFrame: 2 and a half months
measure: Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment
timeFrame: 2 and a half months
measure: MPN progression rate
timeFrame: 2 and a half months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York-Presbyterian/Weill Cornell Medical Center
state: New York
city: Sofia
country: Bulgaria
facility: National Specialised Hospital for Active Treatment of Hematological Diseases
city: Zagreb
country: Croatia
facility: University hospital Dubrava-School of Medicine University of Zagreb
city: Paris
country: France
facility: Hopital Saint-Louis
city: Halle
country: Germany
facility: University Hospital Halle, Department of Hematology/Oncology
state: Saale
city: Aachen
country: Germany
facility: University Medical Center RWTH
city: Greifswald
country: Germany
facility: University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care
city: Minden
country: Germany
facility: University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center
city: Monza
country: Italy
facility: Ospedale San Gerardo di Monza
state: Monza Brianza
city: Alessandria
country: Italy
facility: A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
city: Bergamo
country: Italy
facility: ASST-Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: ASST-Spedali Civili
city: Firenze
country: Italy
facility: AOU Ospedale Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Policlinico Universitario Fondazione Agostino Gemelli
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
city: Verona
country: Italy
facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Wrocław
country: Poland
facility: Sobas Wroclaw Medical University ·
city: Barcelona
country: Spain
facility: Hospital Clínic De Barcelona
state: Barcellona
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Barcellona
city: Badalona
country: Spain
facility: Institut Català d' Oncologia - Hospital Germans Trias i Pujol
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: ICO L'Hospitalet - Hospital Moisès Broggi
state: Barcelona
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Breña Alta
country: Spain
facility: Hospital General de La Palma
state: Santa Cruz De Tenerife
city: Albacete
country: Spain
facility: Servicio de Hematología Hospital General Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General de Elche
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: ICO Girona Hospital Josep Trueta Servei d'hematologia
city: Madrid
country: Spain
facility: FEA Hematología Hospital Universitario de Móstoles
city: Madrid
country: Spain
facility: Hospital 12 de octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Moncloa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust.
Study officials:
affiliation: Fondazione per la Ricerca Ospedale di Bergamo
name: Tiziano Barbui, Prof
role: STUDY_CHAIR
References: