COVID19-hematological Malignancies: the Italian Hematology Alliance
SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance
1 other identifier
observational
250
1 country
81
Brief Summary
This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2020
CompletedFirst Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedSeptember 23, 2022
September 1, 2022
2.5 years
April 9, 2020
September 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To evaluate mortality.
The percentage of HM patients with COVID-19 who died.
At 2 months from study initiation
To evaluate potential predictive biochemical parameters of mortality.
We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.
At 2 months from study initiation
To evaluate potential predictive HM-related parameters of mortality.
We will assess the correlation between HM-related parameters at diagnosis of COVID \[i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)\] and mortality.
At 2 months from study initiation
To evaluate COVID severity as predictive parameter of mortality.
We will assess the correlation between COVID severity \[mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 \< 300 and/or lung infiltrates \> 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)\] and mortality
At 2 months from study initiation
Secondary Outcomes (5)
Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity
At 6 months from study initiation
Definition of complete clinical picture of COVID-19 in HM
At 2 months from study initiation
Evolution of HM
At 2 months from study initiation
To evaluate admission to ICU requiring mechanical ventilation or death per characteristics
At 2 months from study initiation
Viral dynamics in infected HM patients
At 12 months from study initiation
Eligibility Criteria
The study population will must be older than 18 years of age with Hematological malignancies and SARS-CoV-2 infection.
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).
- Active hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma) 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.
- SARS-CoV-2 negative test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
SC Ematologia Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
UOC Ematologia, Ospedali Riuniti
Ancona, Italy
UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni
Ascoli Piceno, Italy
SC Oncologia Medica, CRO
Aviano, Italy
SC Ematologia, Policlinico Bari
Bari, Italy
UOC Ematologia, I.R.C.C.S Istituto Tumori Giovanni Paolo II
Bari, Italy
SSD Ematologia, Ospedale degli Infermi
Biella, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi,
Bologna, Italy
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano
Bolzano, Italy
UO Ematologia e CTMO, ASST Spedali Civili
Brescia, Italy
UO Ematologia e CTMO, ASST Spedali Civili
Brescia, Italy
UOC Onco-Ematologia ASST Valle Olona
Busto Arsizio, Italy
SC Ematologia e CTMO AZIENDA OSPEDALIERA "G. BROTZU" - OSPEDALE ONCOLOGICO BUSINCO
Cagliari, Italy
UOC Ematologia, AOU Policlinico Vittorio Emanuele
Catania, Italy
Ematologia, Ospedale Valduce
Como, Italy
UOC Ematologia, Azienda Ospedaliera di Cosenza
Cosenza, Italy
UO Ematologia e CTMO, ASST Cremona
Cremona, Italy
SC Ematologia Ospedale S. Croce
Cuneo, Italy
UOC, Ematologia Azienda Ospedaliero Universitaria Arcispedale S. Anna
Ferrara, Italy
S.O.D. Ematologia, Azienda Ospedaliero Universitaria Careggi
Florence, Italy
UOC Ematologia, Policlinico Ospedali Riuniti
Foggia, Italy
IRST-IRCC di Meldola
Forlì, Italy
UO Ematologia, Ospedale Policlinico S.Martino IRCCS
Genova, Italy
UO Ematologia, Ospedale Policlinico San Martino
Genova, Italy
UOC di Ematologia e Trapianto di Cellule Staminali, P.O. Vito Fazzi
Lecce, Italy
UOC di Ematologia, Ospedale di Legnano
Legnano, Italy
UO Dipartimento di Ematologia, USL 6
Livorno, Italy
UOC Oncologia ASST Lodi
Lodi, Italy
UOC Ematologia Azienda Ospedaliera Universitaria "G.Martino"
Messina, Italy
UO Ematologia, Ospedale dell'Angelo di Mestre
Mestre, Italy
Ematologia, IEO
Milan, Italy
SC Ematologia, Istituto Nazionale dei Tumori
Milan, Italy
SC Ematologia, Ospedale Niguarda
Milan, Italy
UO Ematologia, IRCCS Ospedale San Raffaele
Milan, Italy
UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco
Milan, Italy
UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
UO Ematologia Policlinico di Modena
Modena, Italy
UOC Ematologia, Ospedale S. Gerardo
Monza, Italy
SC Ematologia Istituto Nazionale Tumori - IRCCS "Fondazione G. Pascale",
Napoli, Italy
UOC Ematologia e Trapianti di Midollo, AOU Federico II
Napoli, Italy
UOC Ematologia, Ospedale Antonio Cardarelli
Napoli, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Maggiore della CaritÃ
Novara, Italy
Ospedale san Luigi Gonzaga
Orbassano, Italy
Ematologia Azienda Ospedaliera di Padova
Padua, Italy
UO Ematologia, Policlinico Paolo Giaccone
Palermo, Italy
UOC Ematologia e CTMO, Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
SC Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
SC Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera di Perugia
Perugia, Italy
UO Ematologia e CTMO, Azienda Ospedaliera Ospedali Riuniti
Pesaro, Italy
UOC di Ematologia, Ospedale Civile Spirito Santo
Pescara, Italy
UO Ematologia e CTMO, Presidio Ospedaliero di Piacenza
Piacenza, Italy
UO Ematologia, AOU Pisana- Santa Chiara
Pisa, Italy
UO Ematologia dell'Ospedale Santa Maria delle Croci
Ravenna, Italy
UOC Ematologia, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
SC Ematologia, Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
UO Ematologia, Ospedale Infermi
Rimini, Italy
AOU Azienda Ospedaliera Universitaria Sant'Andrea
Roma, Italy
IFO - Ematologia e Trapianto Cellule -Istituto Nazionale del Cancro di Regina Elena
Roma, Italy
SC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
UO Ematologia e Trapianti di Cellule Staminali, A.O. S. Camillo-Forlanini
Roma, Italy
UO Ematologia, Policlinico Tor Vergata
Roma, Italy
UOC Ematologia e trapianto di cellule staminali, Policlinico Universitario Campus Bio-Medico
Roma, Italy
UOC Ematologia Policlinico Umberto I
Roma, Italy
UOC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
UOC Ematologia- Azienda Ospedaliera San Giovanni Addolorata
Roma, Italy
UO Ematologia, Istituto Clinico Humanitas
Rozzano, Italy
UOC Ematologia e centro trapianti cellule staminali emopoietiche, AOU San Giovanni Di Dio e Ruggi D'aragona
Salerno, Italy
Ematologia ASL Imperiese
Sanremo, Italy
Medicina Interna ed Ematologia, Asl 1
Savona, Italy
UOC Ematologia, Policlinico Santa Maria alle Scotte
Siena, Italy
UOC Ematologia e Trapianto Midollo Osseo, Ospedale S. G. Moscati
Taranto, Italy
SCDU Ematologia e terapie cellulari, Ospedale Mauriziano Umberto I
Torino, Italy
UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
Torino, Italy
UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
Torino, Italy
UO Ematologia, Ospedale Civili Ca' Foncello
Treviso, Italy
SC Ematologia, Azienda sanitaria universitaria Giuliano Isontina
Trieste, Italy
Clinica Ematologia, Azienda Ospedaliera-Universitaria Santa Maria della Misericordia
Udine, Italy
UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi
Varese, 21100, Italy
UOC Ematologia, Azienda Ospedaliera Integrata di Verona
Verona, Italy
UOC Ematologia, Azienda Ospedaliera Integrata di Verona
Verona, Italy
UOC Ematologia, Ospedale San Bortolo
Vicenza, Italy
Related Publications (7)
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013BACKGROUNDLu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
PMID: 32007145BACKGROUNDXia Y, Jin R, Zhao J, Li W, Shen H. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e180. doi: 10.1016/S1470-2045(20)30150-9. Epub 2020 Mar 3. No abstract available.
PMID: 32142622BACKGROUNDWang H, Zhang L. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e181. doi: 10.1016/S1470-2045(20)30149-2. Epub 2020 Mar 3. No abstract available.
PMID: 32142621BACKGROUNDCorrao G, Rea F, Di Martino M, De Palma R, Scondotto S, Fusco D, Lallo A, Belotti LMB, Ferrante M, Pollina Addario S, Merlino L, Mancia G, Carle F. Developing and validating a novel multisource comorbidity score from administrative data: a large population-based cohort study from Italy. BMJ Open. 2017 Dec 26;7(12):e019503. doi: 10.1136/bmjopen-2017-019503.
PMID: 29282274BACKGROUNDVisco C, Marcheselli L, Mina R, Sassone M, Guidetti A, Penna D, Cattaneo C, Bonuomo V, Busca A, Ferreri AJM, Bruna R, Petrucci L, Cairoli R, Salvini M, Bertu L, Ladetto M, Pilerci S, Pinto A, Ramadan S, Marchesi F, Cavo M, Arcaini L, Coviello E, Romano A, Musto P, Massaia M, Fracchiolla N, Marchetti M, Scattolin A, Tisi MC, Cuneo A, Della Porta M, Trentin L, Turrini M, Gherlinzoni F, Tafuri A, Galimberti S, Bocchia M, Cardinali V, Cilloni D, Corso A, Armiento D, Rigacci L, La Barbera EO, Gambacorti-Passerini C, Visani G, Vallisa D, Venditti A, Selleri C, Conconi A, Tosi P, Lanza F, Candoni A, Krampera M, Corradini P, Passamonti F, Merli F; ITA-HEMA-COV investigators. A prognostic model for patients with lymphoma and COVID-19: a multicentre cohort study. Blood Adv. 2022 Jan 11;6(1):327-338. doi: 10.1182/bloodadvances.2021005691.
PMID: 34644385DERIVEDPassamonti 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: 32798473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Passamonti, MD
Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 20, 2020
Study Start
April 7, 2020
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
September 23, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share