Official Title
Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey
Brief Summary

The overall purpose of this project is to better understand the epidemiology of COVID-19 in patients with hematological malignancies (including hematopoietic stem cell transplant recipients) in the different European Countries. The results obtained will allow us to better know the prevalence of this complication in the different categories of patients with hematological malignancies (HMs). In order to attain the objectives previously described we will develop a multicentre, international, observational, retrospective and prospective study of consecutive cases of COVID-19 among HMs. There will be a clinical follow-up of the patients included in this study to observe the survival rate. Data collected form this study will be evaluated with a descriptive analysis.

Detailed Description

At the moment, few data on the epidemiology of SARS-CoV-2 infection in patients suffering
from hematological malignancies are available. However, the COVID-19 pandemic presents unique
challenges and opportunities on hematological malignancies. The future trajectory of this
pandemic appears to be growing and hematology communities must continue to prepare for its
spread In this project, we will implement cooperation between all members of the hematology
departments both within the EHA and outside it, in order to evaluate the epidemiological data
on the incidence and outcome in patients with hematological malignancies infected with
SARS-CoV-2.

We will provide useful information to inform the individualized plan for patients with
hematological malignancies.

We aim to evaluate the epidemiology and outcomes of patients with HM infected with
COVID-19,estimate the incidence and type of disease, assess the acute and long-term mortality
rate and estimate the overall mortality rate of cases.

This is a cohort retrospective/prospective survey. In the retrospective phase of the study,
participating centers will retrospectively review episodes of COVID-19 disease that occurred
in patients with hematological malignancies identified at their institutions from February
2020 to December 2020. In the prospective phase of the study, the researchers will include
episodes of COVID-19 disease from the start of the study through December 31, 2021.

The study population will need to be over 18 with hematological malignancies and SARS-CoV-2
An electronic database with anonymization will be created and available to collect all
information with single access for each participating institution. The data collected will be
demographic data,epidemiological factors, admission information, COVID-19 disease severity,
history of hematological malignancies, disease status with past / current treatments, and 30
days of diagnosis.

Recruiting
COVID-19 Infection in Hematological Malignancies Patients
Eligibility Criteria

Inclusion Criteria:

- Age equal to or greater than 18 years of age.

- History of hematological malignancies (acute leukemias, myelodysplastic syndromes,
myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative
disorders) at any stage/status.

- Active hematological malignancies at any stage/status.

- Diagnosis of hematological malignancy (acute leukemias, myelodysplastic syndromes,
myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative
disorders) at any stage/status.

- SARS-CoV-2 positive test (nasopharyngeal, BAL, fecal), documented by Real-Time Reverse
Transcriptase (RT)-PCR Diagnostic Panels.

Exclusion Criteria:

- Hematological diseases, other than hematological malignancies.

- Not tested positive for SARS-CoV-2

- Patients "off therapy" for more than 5 years

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
Italy
Locations

ASST-Spedali Civili
Brescia, Italy

AOU Policlinico Federico II
Napoli, Italy

Fondazione Policlinico A. Gemelli IRCCS
Rome, Italy

Istituto Nazionale Tumori Regina Elena IFO
Rome, Italy

Osp. di Circolo-Fondazione Macchi
Varese, Italy

AOUI Verona
Verona, Italy

Contacts

livio pagano, Prof
+390630154180
livio.pagano@unicatt.it

Jon Salmanton Garcia, Dr
jon.salmanton-garcia@uk-koeln.de

European Hematology Association
NCT Number
MeSH Terms
Infections
COVID-19
Neoplasms
Hematologic Neoplasms