Patients with hematological malignancies may be immunosuppressed due to both their disease and treatment they may be receiving, making them more likely to suffer infections. There is a lack of data around the relative benefits and risks faced by these patients given the current COVID-19 pandemic and so a paucity of guidance on how best to adapt individualized treatment plans.
Livio Pagano, Universitario A. Gemelli – IRCCS - Università Cattolica del Sacro Cuore, Italy.
In this project, which commenced in May 2020, participating centers will retrospectively review all episodes of COVID-19 in patients with hematological malignancies identified at their institutions since February 2020. A prospective phase of the study will include episodes of COVID-19 occurring from study start to 31 October 2020. The survey will finish in December 2021.
The current outbreak caused by the novel human coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes 2019 novel coronavirus disease (COVID-19), has been declared a global pandemic by the World Health Organization (WHO). The potential threat posed by COVID-19 to immune-compromised patients is thought to be significant. However, limited data exist on the effects of COVID-19 in those who are immunosuppressed, particularly patients with hematological malignancies (HM).
The systemic immunosuppressive effects of HMs, such as acute and chronic leukemias, lymphomas and myeloma, and those of anticancer treatments, increase patient susceptibility to infections, which may pose an increased risk in a pandemic situation. Conversely, the benefits of treatment for HM have been well documented; effective treatments can significantly change the course of disease. Given the novel nature of COVID-19 and the lack of data in HM patients, there is a need for further studies in a greater number of patients to allow a more educated assessment of benefit and risk when designing individualized treatment plans for these patients.
This non-interventional observational study will both retrospectively and prospectively gather data from researchers in different European countries for all cases of COVID-19 occurring in patients with HMs at their institutions. Data will be entered into an anonymized electronic database and will include demographics, epidemiological factors, admission information, severity of COVID-19 disease, history of hematological malignancies, disease status with past/ongoing treatments, and outcome at 30 days from diagnosis. No formal sample size is planned; however, given that this is a multicenter cohort study on a high-incident disease with an elevated expected number of events (death, complications and co-infections), it is anticipated that data from over 600 patients will be collected. The study will assess the epidemiology and outcomes of patients with HM who are infected with COVID-19. The study will also aim to estimate the prevalence and type of COVID-19 disease (i.e. symptomatic, asymptomatic or severe), the prevalence of severe COVID-19 cases requiring intensive care unit (ICU) admission, the frequency of pre-existing co-morbidities, the acute mortality rate, the overall case-fatality rate, and the spatial-geographical patterns of disease. Patients will also be stratified per off-therapy/on-therapy, type of therapy (chemotherapy, immunotherapy, cell therapy or stem cell transplant).
Overall, this study aims to build an up-to-date and comprehensive picture of the potential threat of COVID-19 to immune-compromised patients with HM. Findings will enable doctors to more accurately assess the risks and benefits faced by patients with HM currently undergoing treatment, and thus determine whether treatment can continue or if the treatment plan requires modification. Ultimately, it is hoped that knowledge gained from the study will lead to improved therapeutic strategies and optimized outcomes for these patients.
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