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SARS-CoV-2 InfectionNCT04352556

COVID19-hematological Malignancies: the Italian Hematology Alliance

An observational study of SARS-CoV-2 Infection and Hematological Malignancies, run by Ospedale di Circolo - Fondazione Macchi at 81 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
250 participants
Where
81 sitesItaly
Study dates
7 Apr 2020to 1 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will must be older than 18 years of age with Hematological malignancies and SARS-CoV-2 infection.

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).
  • 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.

Who cannot join

  • Hematological diseases, other than hematological malignancies.
  • SARS-CoV-2 negative test.

Trial locations and contacts

81 sites in 1 country.

Francesco Passamonti, MD contact

+39-0332-393648

francesco.passamonti@asst-settelaghi.it

Marco Salvini, MD contact

marco.salvini@asst-settelaghi.it

81 sites in 1 country

Italy81 sites, 81 recruiting

  • SC Ematologia Ospedale SS Antonio e Biagio e Cesare Arrigo

    Alessandria

    Marco Ladetto, MD

    Recruiting

  • UOC Ematologia, Ospedali Riuniti

    Ancona

    Attilio Olivieri, MD

    Recruiting

  • UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni

    Ascoli Piceno

    Piero Galieni, MD

    Recruiting

  • SC Oncologia Medica, CRO

    Aviano

    Michele Spina, MD

    Recruiting

  • SC Ematologia, Policlinico Bari

    Bari

    Pellegrino Musto, MD

    Recruiting

  • UOC Ematologia, I.R.C.C.S Istituto Tumori Giovanni Paolo II

    Bari

    Attilio Guarini, MD

    Recruiting

  • SSD Ematologia, Ospedale degli Infermi

    Biella

    Anna Conconi, MD

    Recruiting

  • UOC Ematologia, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi,

    Bologna

    Michele Cavo, MD

    Recruiting

  • Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano

    Bolzano

    Atto Billio, MD

    Recruiting

  • UO Ematologia e CTMO, ASST Spedali Civili

    Brescia

    Domenico Russo, MD

    Recruiting

  • UO Ematologia e CTMO, ASST Spedali Civili

    Brescia

    Chiara Cattaneo, MD

    Recruiting

  • UOC Onco-Ematologia ASST Valle Olona

    Busto Arsizio

    Fabrizio Ciambelli, MD

    Recruiting

  • SC Ematologia e CTMO AZIENDA OSPEDALIERA "G. BROTZU" - OSPEDALE ONCOLOGICO BUSINCO

    Cagliari

    Giorgio La Nasa, MD

    Recruiting

  • UOC Ematologia, AOU Policlinico Vittorio Emanuele

    Catania

    Francesco Di Raimondo, MD

    Recruiting

  • Ematologia, Ospedale Valduce

    Como

    Mauro Turrini, MD

    Recruiting

  • UOC Ematologia, Azienda Ospedaliera di Cosenza

    Cosenza

    Massimo Gentile, MD

    Recruiting

  • UO Ematologia e CTMO, ASST Cremona

    Cremona

    Alfredo Molteni, MD

    Recruiting

  • SC Ematologia Ospedale S. Croce

    Cuneo

    Massimo Massaia, MD

    Recruiting

  • UOC, Ematologia Azienda Ospedaliero Universitaria Arcispedale S. Anna

    Ferrara

    Antonio Cuneo, MD

    Recruiting

  • S.O.D. Ematologia, Azienda Ospedaliero Universitaria Careggi

    Florence

    Alberto Bosi, MD

    Recruiting

  • UOC Ematologia, Policlinico Ospedali Riuniti

    Foggia

    Celestino Ferrandina, MD

    Recruiting

  • IRST-IRCC di Meldola

    Forlì

    Giovanni Martinelli, MD

    Recruiting

  • UO Ematologia, Ospedale Policlinico S.Martino IRCCS

    Genova

    Roberto Lemoli, MD

    Recruiting

  • UO Ematologia, Ospedale Policlinico San Martino

    Genova

    Emanuele Angelucci, MD

    Recruiting

  • UOC di Ematologia e Trapianto di Cellule Staminali, P.O. Vito Fazzi

    Lecce

    Nicola Di Renzo, MD

    Recruiting

  • UOC di Ematologia, Ospedale di Legnano

    Legnano

    Alessandro Corso, MD

    Recruiting

  • UO Dipartimento di Ematologia, USL 6

    Livorno

    Annarosa Cuccaro, MD

    Recruiting

  • UOC Oncologia ASST Lodi

    Lodi

    Alessandro Inzoli, MD

    Recruiting

  • UOC Ematologia Azienda Ospedaliera Universitaria "G.Martino"

    Messina

    Caterina Musolino, MD

    Recruiting

  • UO Ematologia, Ospedale dell'Angelo di Mestre

    Mestre

    Renato Bassan, MD

    Recruiting

  • Ematologia, IEO

    Milan

    Corrado Tarella, MD

    Recruiting

  • SC Ematologia, Istituto Nazionale dei Tumori

    Milan

    Paolo Corradini, MD

    Recruiting

  • SC Ematologia, Ospedale Niguarda

    Milan

    Roberto Cairoli, MD

    Recruiting

  • UO Ematologia, IRCCS Ospedale San Raffaele

    Milan

    Fabio Ciceri, MD

    Recruiting

  • UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco

    Milan

    Augusto Federici, MD

    Recruiting

  • UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

    Nicola Fracchiolla, MD

    Recruiting

  • UO Ematologia Policlinico di Modena

    Modena

    Mario Luppi, MD

    Recruiting

  • UOC Ematologia, Ospedale S. Gerardo

    Monza

    Carlo Gambacorti Passerini, MD

    Recruiting

  • SC Ematologia Istituto Nazionale Tumori - IRCCS "Fondazione G. Pascale",

    Naples

    Antonio Pinto, MD

    Recruiting

  • UOC Ematologia e Trapianti di Midollo, AOU Federico II

    Naples

    Fabrizio Pane, MD

    Recruiting

  • UOC Ematologia, Ospedale Antonio Cardarelli

    Naples

    Felicetto Ferrara, MD

    Recruiting

  • UOC Ematologia, Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara

    Gianluca Gaidano, MD

    Recruiting

  • Ospedale san Luigi Gonzaga

    Orbassano

    Daniela Cilloni, MD

    Recruiting

  • Ematologia Azienda Ospedaliera di Padova

    Padova

    Giampietro Semenzato, MD

    Recruiting

  • UO Ematologia, Policlinico Paolo Giaccone

    Palermo

    Sergio Siragusa, MD

    Recruiting

  • UOC Ematologia e CTMO, Azienda Ospedaliero-Universitaria di Parma

    Parma

    Nicola Giuliani, MD

    Recruiting

  • SC Ematologia, Fondazione IRCCS Policlinico San Matteo

    Pavia

    Luca Arcaini, MD

    Recruiting

  • SC Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera di Perugia

    Perugia

    Brunangelo Falini, MD

    Recruiting

  • UO Ematologia e CTMO, Azienda Ospedaliera Ospedali Riuniti

    Pesaro

    Giuseppe Visani, MD

    Recruiting

  • UOC di Ematologia, Ospedale Civile Spirito Santo

    Pescara

    Antonio Spadano, MD

    Recruiting

  • UO Ematologia e CTMO, Presidio Ospedaliero di Piacenza

    Piacenza

    Daniele Vallisa, MD

    Recruiting

  • UO Ematologia, AOU Pisana- Santa Chiara

    Pisa

    Sara Galimberti, MD

    Recruiting

  • UO Ematologia dell'Ospedale Santa Maria delle Croci

    Ravenna

    Francesco Lanza, MD

    Recruiting

  • UOC Ematologia, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria

    Bruno Martino, MD

    Recruiting

  • SC Ematologia, Arcispedale Santa Maria Nuova

    Reggio Emilia

    Francesco Merli, MD

    Recruiting

  • UO Ematologia, Ospedale Infermi

    Rimini

    Patrizia Tosi, MD

    Recruiting

  • AOU Azienda Ospedaliera Universitaria Sant'Andrea

    Roma

    Agostino Tafuri, MD

    Recruiting

  • IFO - Ematologia e Trapianto Cellule -Istituto Nazionale del Cancro di Regina Elena

    Roma

    Francesco Marchesi, MD

    Recruiting

  • SC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Livio Pagano, MD

    Recruiting

  • UO Ematologia e Trapianti di Cellule Staminali, A.O. S. Camillo-Forlanini

    Roma

    Luigi Rigacci, MD

    Recruiting

  • UO Ematologia, Policlinico Tor Vergata

    Roma

    Adriano Venditti, MD

    Recruiting

  • UOC Ematologia e trapianto di cellule staminali, Policlinico Universitario Campus Bio-Medico

    Roma

    Giuseppe Avvisati, MD

    Recruiting

  • UOC Ematologia Policlinico Umberto I

    Roma

    Maurizio Martelli, MD

    Recruiting

  • UOC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Valerio De Stefano, MD

    Recruiting

  • UOC Ematologia- Azienda Ospedaliera San Giovanni Addolorata

    Roma

    Laura Cudillo, MD

    Recruiting

  • UO Ematologia, Istituto Clinico Humanitas

    Rozzano

    Matteo Della Porta, MD

    Recruiting

  • UOC Ematologia e centro trapianti cellule staminali emopoietiche, AOU San Giovanni Di Dio e Ruggi D'aragona

    Salerno

    Carmine Selleri, MD

    Recruiting

  • Ematologia ASL Imperiese

    Sanremo

    Tullio Calzamiglia, MD

    Recruiting

  • Medicina Interna ed Ematologia, Asl 1

    Savona

    Marina Cavaliere, MD

    Recruiting

  • UOC Ematologia, Policlinico Santa Maria alle Scotte

    Siena

    Monica Bocchia, MD

    Recruiting

  • UOC Ematologia e Trapianto Midollo Osseo, Ospedale S. G. Moscati

    Taranto

    Patrizio Mazza, MD

    Recruiting

  • SCDU Ematologia e terapie cellulari, Ospedale Mauriziano Umberto I

    Torino

    Carmen Fava, MD

    Recruiting

  • UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista

    Torino

    Benedetto Bruno, MD

    Recruiting

  • UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista

    Torino

    Alessandro Busca, MD

    Recruiting

  • UO Ematologia, Ospedale Civili Ca' Foncello

    Treviso

    Filippo Gherlinzoni, MD

    Recruiting

  • SC Ematologia, Azienda sanitaria universitaria Giuliano Isontina

    Trieste

    Francesco Zaja, MD

    Recruiting

  • Clinica Ematologia, Azienda Ospedaliera-Universitaria Santa Maria della Misericordia

    Udine

    Renato Fanin, MD

    Recruiting

  • UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi

    Varese, 21100

    Francesco Passamonti, MD

    Recruiting

  • UOC Ematologia, Azienda Ospedaliera Integrata di Verona

    Verona

    Mauro Krampera, MD

    Recruiting

  • UOC Ematologia, Azienda Ospedaliera Integrata di Verona

    Verona

    Carlo Visco, MD

    Recruiting

  • UOC Ematologia, Ospedale San Bortolo

    Vicenza

    Marco Ruggeri, MD

    Recruiting

Other trials in Italy

About this study

Official title: SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance

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.

Read the detailed description

This is a retrospective/prospective, cohort, non-interventional observational study. An informed consensus for the participation is available. In this section we provide informations on sample size and statistical analysis.

In Italy, the projected estimate of complete HM prevalence at Jan 1, 2020 has been established as 48,254 cases for Hodgkin lymphoma, 110.715 cases for non Hodgkin Lymphomas, 67,301 for leukemias, and 25,066 for multiple myeloma (Guzzinati et al, BMC Cancer 2018). The Italian Dipartimento della Protezione Civile website reported (March 23, 2020) that 63,927 cases are currently infected with SARS-CoV-2. No formal sample size calculation was made for this project but, on the basis of data available to date, considering the prevalence of hematological patients in Italy (0.4%) and assuming that these patients have the same risk of contracting COVID-19 as the general population, we supposed to enroll at least 250 patients (at March 24, 2020).

Statistical analyses All data collected will be summarized using appropriate descriptive statistics: absolute and relative frequencies for discrete variables; mean, standard deviation, median and interquartile range for continuous ones. To identify factors significantly associated with composite endpoint, log-binomial regression will be used for modelling risk ratio together with 95% confidence interval estimated.

The least absolute shrinkage and selection operator (LASSO) method will be applied for selecting the factors able to independently predict primary end-point. LASSO selects variables correlates to the measured outcome by shrinking coefficients weights, down to zero for the ones not correlated to outcome. In addition, machine learning techniques will be used for validating results from LASSO. A weight will be assigned to each coefficient of the selected predictors and weights will be summed to produce a total aggregate score. Predictive performance will be assessed through discrimination and calibration. Discrimination indicates how well the model can distinguish individuals with the outcome from those without the outcome. Two, the net reclassification improvement (NRI) will be calculated for assessing the 'net' number of individuals correctly reclassified using "the new model" over a comparator index [i.e., CCI (Charlson Comorbidity Score) or MCS (Multisource Comorbidity Score), or HM-disease specific]. Calibration ascertains the concordance between the model's predictions and observed outcomes, which we evaluated using a calibration plot. Cartographic and geostatistical methods will be used to exploring the spatial patterns of disease. An Exploratory Spatial Data Analysis (ESDA) and the Kriging method will be also applied to describe and model spatial (geographical) pattern.

Keywords
Hematological Malignancies, Covid-19, SARS-CoV-2, Italian Hematology Alliance, Leukemia, Lymphoma, Multiple Myeloma
Medical subject headings
COVID-19, Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate mortality.

    The percentage of HM patients with COVID-19 who died.

    Measured: At 2 months from study initiation

  2. 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.

    Measured: At 2 months from study initiation

  3. 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.

    Measured: At 2 months from study initiation

  4. 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

    Measured: At 2 months from study initiation

Secondary outcomes (5)

  1. Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity

    Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of 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 disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)

    Measured: At 6 months from study initiation

  2. Definition of complete clinical picture of COVID-19 in HM

    Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.

    Measured: At 2 months from study initiation

  3. Evolution of HM

    Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.

    Measured: At 2 months from study initiation

  4. To evaluate admission to ICU requiring mechanical ventilation or death per characteristics

    Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).

    Measured: At 2 months from study initiation

  5. Viral dynamics in infected HM patients

    Measured: At 12 months from study initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start7 Apr 2020
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Resources

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
Other
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04352556
Sponsor's protocol ID
HM-COVID19-Italy
Status last verified
Sep 2022
First submitted
9 Apr 2020
Last updated
23 Sep 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32109013

  • Lu 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.

    PubMed 32007145

  • Xia 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.

    PubMed 32142622

  • Wang 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.

    PubMed 32142621

  • Corrao 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.

    PubMed 29282274

  • Visco 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.

    PubMed 34644385

  • 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 32798473

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 Infection and Hematological Malignancies, run by Ospedale di Circolo - Fondazione Macchi at 81 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesco Passamonti, MD (+39-0332-393648, francesco.passamonti@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate mortality. (time frame: At 2 months from study initiation). The study lists 4 primary outcomes in all. 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 NCT04352556, which also lists 7 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 23 Sep 2022.

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