NCT04385160

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
9 countries

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

May 11, 2020

Last Update Submit

September 9, 2025

Conditions

Keywords

thrombosis

Outcome Measures

Primary Outcomes (1)

  • pulmonary embolism (PE)

    Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism

    2 and a half months

Secondary Outcomes (10)

  • fatal or non fatal thrombotic event

    2 and a half months

  • Continuous Positive Airway Pressure (CPAP)

    2 and a half months

  • invasive ventilation

    2 and a half months

  • admission in Intensive Care Unit (ICU)

    2 and a half months

  • death

    2 and a half months

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

National Specialised Hospital for Active Treatment of Hematological Diseases

Sofia, Bulgaria

Location

University hospital Dubrava-School of Medicine University of Zagreb

Zagreb, Croatia

Location

Hopital Saint-Louis

Paris, France

Location

University Hospital Halle, Department of Hematology/Oncology

Halle, Saale, 06112, Germany

Location

University Medical Center RWTH

Aachen, Germany

Location

University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care

Greifswald, 17475, Germany

Location

University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center

Minden, Germany

Location

Ospedale San Gerardo di Monza

Monza, Monza Brianza, 20900, Italy

Location

A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria

Alessandria, 15121, Italy

Location

ASST-Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

ASST-Spedali Civili

Brescia, 25123, Italy

Location

AOU Ospedale Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Policlinico Universitario Fondazione Agostino Gemelli

Roma, 00168, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Ospedale Policlinico "G.B. Rossi" Borgo Roma

Verona, 37134, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Sobas Wroclaw Medical University ·

Wroclaw, Poland

Location

Hospital Clínic De Barcelona

Barcelona, Barcellona, Spain

Location

Hospital del Mar

Barcelona, Barcellona, Spain

Location

Institut Català d' Oncologia - Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

ICO L'Hospitalet - Hospital Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital General de La Palma

Breña Alta, Santa Cruz De Tenerife, Spain

Location

Servicio de Hematología Hospital General Universitario de Albacete

Albacete, Spain

Location

Hospital General de Elche

Alicante, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

ICO Girona Hospital Josep Trueta Servei d'hematologia

Girona, Spain

Location

FEA Hematología Hospital Universitario de Móstoles

Madrid, Spain

Location

Hospital 12 de octubre

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Moncloa

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Clínico Universitario

Valencia, Spain

Location

Guy's and St. Thomas' NHS Foundation Trust.

London, United Kingdom

Location

MeSH Terms

Conditions

Myeloproliferative DisordersThrombosis

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Tiziano Barbui, Prof

    Fondazione per la Ricerca Ospedale di Bergamo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 12, 2020

Study Start

May 13, 2020

Primary Completion

February 15, 2022

Study Completion

August 31, 2022

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Each participant can visualize its own data on eCRF after the completion patient's electronic data form.

Locations