Covid-19 in Hematological Malignancies

NCT04733729 | Recruiting

• 1 other identifier: EHA-IDWG
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID-19 Infection in Hematological Malignancies Patients

Outcome Measures

Primary Outcomes (1)

• Epidemiology of COVID-19 infection in patients with hematological malignancies

  to evaluate the epidemiology of COVID infection among all hema malignancies patients subgroups

  2020 (1 year)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No formal sample size is planned for this study because not only the main hypothesis will be assessed. However, this is a multicentre cohort study on a high incident disease, with an elevated expected number of events (death, complications, and co-infections) to be observed. So more than 2000 patients are expected to be included.

You may qualify if:

• 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.

You may not qualify if:

• Hematological diseases, other than hematological malignancies.
• Not tested positive for SARS-CoV-2
• Patients "off therapy" for more than 5 years

Sponsors & Collaborators

• Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne: lead
• European Hematology Association: collaborator

Study Sites (6)

ASST-Spedali Civili

Brescia, Italy

RECRUITING

AOU Policlinico Federico II

Napoli, Italy

RECRUITING

Fondazione Policlinico A. Gemelli IRCCS

Rome, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena IFO

Rome, Italy

RECRUITING

Osp. di Circolo-Fondazione Macchi

Varese, Italy

RECRUITING

AOUI Verona

Verona, Italy

RECRUITING

Related Publications (4)

• Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, Angelucci E, Krampera M, Cairoli R, Della Porta MG, Fracchiolla N, Ladetto M, Gambacorti Passerini C, Salvini M, Marchetti M, Lemoli R, Molteni A, Busca A, Cuneo A, Romano A, Giuliani N, Galimberti S, Corso A, Morotti A, Falini B, Billio A, Gherlinzoni F, Visani G, Tisi MC, Tafuri A, Tosi P, Lanza F, Massaia M, Turrini M, Ferrara F, Gurrieri C, Vallisa D, Martelli M, Derenzini E, Guarini A, Conconi A, Cuccaro A, Cudillo L, Russo D, Ciambelli F, Scattolin AM, Luppi M, Selleri C, Ortu La Barbera E, Ferrandina C, Di Renzo N, Olivieri A, Bocchia M, Gentile M, Marchesi F, Musto P, Federici AB, Candoni A, Venditti A, Fava C, Pinto A, Galieni P, Rigacci L, Armiento D, Pane F, Oberti M, Zappasodi P, Visco C, Franchi M, Grossi PA, Bertu L, Corrao G, Pagano L, Corradini P; ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol. 2020 Oct;7(10):e737-e745. doi: 10.1016/S2352-3026(20)30251-9. Epub 2020 Aug 13.

  PMID: 32798473 BACKGROUND

• Garcia-Suarez J, de la Cruz J, Cedillo A, Llamas P, Duarte R, Jimenez-Yuste V, Hernandez-Rivas JA, Gil-Manso R, Kwon M, Sanchez-Godoy P, Martinez-Barranco P, Colas-Lahuerta B, Herrera P, Benito-Parra L, Alegre A, Velasco A, Matilla A, Alaez-Uson MC, Martos-Martinez R, Martinez-Chamorro C, Susana-Quiroz K, Del Campo JF, de la Fuente A, Herraez R, Pascual A, Gomez E, Perez-Oteyza J, Ruiz E, Alonso A, Gonzalez-Medina J, Martin-Buitrago LN, Canales M, Gonzalez-Gascon I, Vicente-Ayuso MC, Valenciano S, Roa MG, Monteliu PE, Lopez-Jimenez J, Escobar CE, Ortiz-Martin J, Diez-Martin JL, Martinez-Lopez J; Asociacion Madrilena de Hematologia y Hemoterapia (AMHH). Impact of hematologic malignancy and type of cancer therapy on COVID-19 severity and mortality: lessons from a large population-based registry study. J Hematol Oncol. 2020 Oct 8;13(1):133. doi: 10.1186/s13045-020-00970-7.

  PMID: 33032660 BACKGROUND

• Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G Jr, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL; COVID-19 and Cancer Consortium. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet. 2020 Jun 20;395(10241):1907-1918. doi: 10.1016/S0140-6736(20)31187-9. Epub 2020 May 28.

  PMID: 32473681 BACKGROUND

• 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.

  PMID: 37058479 DERIVED

Related Links

• COVID-19 in pediatric malignancies
• ASH webpage on COVID in hematology

Central Study Contacts

livio pagano, Prof

CONTACT

+390630154180; livio.pagano@unicatt.it

Jon Salmanton Garcia, Dr

CONTACT

jon.salmanton-garcia@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of Hematology

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 2, 2021
• Study Start: March 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)