Prof. Tiziano Barbui, MD, Scientific Director , Foundation of Clinical Research-FROM , Ospedale Papa Giovanni XXIII, Bergamo, Italy: “It is not known whether patients with MPN have a particularly high infectious disease severity with SARS-CoV-19 or whether the necessary suspension or modification of the doses of the drugs used for MPN can influence the history of this disease.”
Coronavirus disease 2019 (Covid-19) has been declared a global pandemic by the World Health Organisation and is spreading extensively across Europe. Early evidence suggests that thrombogenesis is one of the major pathogenic factors implicated in SARS-CoV-19 infection. 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.
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. The interplay of MPN and Covid-19 on thrombogenesis also creates challenges in optimal drug treatment, particularly the role of antithrombotic therapy, managing cytoreductive treatment and the possible interaction of MPN drugs with those used to combat Covid-19.
This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease using the power of the HARMONY Big Data Platform. As part of a predetermined protocol, around 80 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 captured and collated in the HARMONY platform, 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.
Timeframe: Start 15 February 2020 | End 30 June 2020