COVID-19 Infection in Hematological Malignancies PatientsEPICOVIDEHANCT04733729
Covid-19 in Hematological Malignancies
An observational study of COVID-19 Infection in Hematological Malignancies Patients, run by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19 Infection in Hematological Malignancies Patients
- How many people
- 3,000 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Mar 2020to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Hematological diseases, other than hematological malignancies.
- Not tested positive for SARS-CoV-2
- Patients "off therapy" for more than 5 years
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jon Salmanton Garcia, Dr contact
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
ASST-Spedali Civili
Brescia
Chiara Cattaneo
- Recruiting
AOU Policlinico Federico II
Naples
Marco Picardi
- Recruiting
Fondazione Policlinico A. Gemelli IRCCS
Rome
Livio Pagano
Marianna Criscuolo
- Recruiting
Istituto Nazionale Tumori Regina Elena IFO
Rome
Francesco Marchesi
- Recruiting
Osp. di Circolo-Fondazione Macchi
Varese
Claudia Maria Basilico
- Recruiting
AOUI Verona
Verona
Gianpaolo Nadali
About this study
Official title: Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of COVID-19 infection in patients with hematological malignancies
to evaluate the epidemiology of COVID infection among all hema malignancies patients subgroups
Measured: 2020 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Mar 2020
- Primary completion30 Sep 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Infection in Hematological Malignancies PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
- Sponsor type
- University, hospital or other
- Collaborators
- European Hematology Association
- Responsible party
- Principal investigator, LIVIO PAGANO, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733729
- Sponsor's protocol ID
- EHA-IDWG
- Acronym
- EPICOVIDEHA
- Status last verified
- May 2025
- First submitted
- 31 Jan 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32798473Garcia-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.
PubMed 33032660Kuderer 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.
PubMed 32473681van 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.
PubMed 37058479
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey
- ClinicalTrials.gov ID
- NCT04733729
- Acronym / sponsor ID
- EPICOVIDEHA / EHA-IDWG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sorveglianza Epidemiologica Infezioni Fungine Emopatie MaligneUniversity, hospital or other
- Collaborators
- European Hematology Association
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Hematological diseases, other than hematological malignancies.
- Not tested positive for SARS-CoV-2
- Patients "off therapy" for more than 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of COVID-19 infection in patients with hematological malignancies
Time frame: 2020 (1 year)
to evaluate the epidemiology of COVID infection among all hema malignancies patients subgroups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: PubMed 32798473Passamonti 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.
- Results publication: PubMed 33032660Garcia-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.
- Results publication: PubMed 32473681Kuderer 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.
- Derived from this study: PubMed 37058479van 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.
- COVID-19 in pediatric malignanciesLink provided by the sponsor.
- ASH webpage on COVID in hematologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jon Salmanton Garcia, Dr contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection in Hematological Malignancies Patients, run by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact livio pagano, Prof (+390630154180, livio.pagano@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of COVID-19 infection in patients with hematological malignancies (time frame: 2020 (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733729, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.