Myeloproliferative Neoplasms (MPN) and COVID-19

COVID Clinical Trial

— MPN-COVID  

Official title:

Myeloproliferative Neoplasms (MPN) and COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385160
• Other study ID #: FROM - O-MPN-COVID-2020
• Status: Recruiting
• Start date: May 13, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2022
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: Francesca Fenili
• Phone: 0352678926
• Email: ffenili[@]fondazionefrom.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 552
• Est. completion date: August 31, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms

Locations

Country	Name	City	State
Bulgaria	National Specialised Hospital for Active Treatment of Hematological Diseases	Sofia
Croatia	University hospital Dubrava-School of Medicine University of Zagreb	Zagreb
France	Hopital Saint-Louis	Paris
Germany	University Medical Center RWTH	Aachen
Germany	University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care	Greifswald
Germany	University Hospital Halle, Department of Hematology/Oncology	Halle	Saale
Germany	University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center	Minden
Italy	A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria	Alessandria
Italy	ASST-Papa Giovanni XXIII	Bergamo
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	ASST-Spedali Civili	Brescia
Italy	AOU Ospedale Careggi	Firenze
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Ospedale San Gerardo di Monza	Monza	Monza Brianza
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità	Novara
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Policlinico Universitario Fondazione Agostino Gemelli	Roma
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino
Italy	Ospedale Policlinico "G.B. Rossi" Borgo Roma	Verona
Italy	Ospedale San Bortolo	Vicenza
Poland	Sobas Wroclaw Medical University ·	Wroclaw
Spain	Servicio de Hematología Hospital General Universitario de Albacete	Albacete
Spain	Hospital Universitario Príncipe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital General de Elche	Alicante
Spain	Institut Català d' Oncologia - Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic De Barcelona	Barcelona	Barcellona
Spain	Hospital del Mar	Barcelona	Barcellona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital General de La Palma	Breña Alta	Santa Cruz De Tenerife
Spain	Hospital Universitario de Burgos	Burgos
Spain	ICO Girona Hospital Josep Trueta Servei d'hematologia	Girona
Spain	FEA Hematología Hospital Universitario de Móstoles	Madrid
Spain	Hospital 12 de octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Moncloa	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	ICO L'Hospitalet - Hospital Moisès Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Clínico Universitario	Valencia
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust.	London
United States	New York-Presbyterian/Weill Cornell Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore	European Leukemia Net

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary embolism (PE)	Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism	2 and a half months
Secondary	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	2 and a half months
Secondary	Continuous Positive Airway Pressure (CPAP)	Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)	2 and a half months
Secondary	invasive ventilation	Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation	2 and a half months
Secondary	admission in Intensive Care Unit (ICU)	Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)	2 and a half months
Secondary	death	incidence of death	2 and a half months
Secondary	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	2 and a half months
Secondary	treatments and interventions applied for COVID-19	Type of treatments and interventions applied for COVID-19,	2 and a half months
Secondary	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	2 and a half months
Secondary	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	2 and a half months
Secondary	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	2 and a half months