Covid-19 in Hematological Malignancies

NCT ID: NCT04733729

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

COVID-19 Infection in Hematological Malignancies Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Hematology Association

UNKNOWN

Sponsor Role: collaborator

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

OTHER

Sponsor Role: lead

Responsible Party

LIVIO PAGANO

Associated Professor of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASST-Spedali Civili

Brescia, , Italy

Site Status: RECRUITING

AOU Policlinico Federico II

Napoli, , Italy

Site Status: RECRUITING

Fondazione Policlinico A. Gemelli IRCCS

Rome, , Italy

Site Status: RECRUITING

Istituto Nazionale Tumori Regina Elena IFO

Rome, , Italy

Site Status: RECRUITING

Osp. di Circolo-Fondazione Macchi

Varese, , Italy

Site Status: RECRUITING

AOUI Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

livio pagano, Prof

Role: CONTACT

livio.pagano@unicatt.it

+390630154180

Jon Salmanton Garcia, Dr

Role: CONTACT

jon.salmanton-garcia@uk-koeln.de

Facility Contacts

Chiara Cattaneo

Role: primary

Marco Picardi

Role: primary

Livio Pagano

Role: primary

Marianna Criscuolo

Role: backup

Francesco Marchesi

Role: primary

Claudia Maria Basilico

Role: primary

Gianpaolo Nadali

Role: primary

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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van Doesum JA, Salmanton-Garcia J, Marchesi F, Di Blasi R, Falces-Romero I, Cabirta A, Farina F, Besson C, Weinbergerova B, Van Praet J, Schonlein M, Lopez-Garcia A, Lamure S, Guidetti A, De Ramon-Sanchez C, Batinic J, Gavriilaki E, Tragiannidis A, Tisi MC, Plantefeve G, Petzer V, Ormazabal-Velez I, Marques de Almeida J, Marchetti M, Maertens J, Machado M, Kulasekararaj A, Hernandez-Rivas JA, Gomes da Silva M, Fernandez N, Espigado I, Drgona L, Dragonetti G, Metafuni E, Calbacho M, Blennow O, Wolf D, van Anrooij B, Nunes Rodrigues R, Nordlander A, Martin-Gonzalez JA, Lievin R, Jimenez M, Grafe SK, Garcia-Sanz R, Cordoba R, Rahimli L, van Meerten T, Cornely OA, Pagano L. Impact of SARS-CoV-2 vaccination and monoclonal antibodies on outcome post-CD19-directed CAR T-cell therapy: an EPICOVIDEHA survey. Blood Adv. 2023 Jun 13;7(11):2645-2655. doi: 10.1182/bloodadvances.2022009578.

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Related Links

https://global.stjude.org/en-us/global-covid-19-observatory-and-resource-center-for-childhood-cancer/registry.html

COVID-19 in pediatric malignancies

https://www.hematology.org/covid-19/ash-astct-covid-19-and-vaccines

ASH webpage on COVID in hematology

Other Identifiers

EHA-IDWG

Identifier Type: -

Identifier Source: org_study_id