- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352556
COVID19-hematological Malignancies: the Italian Hematology Alliance
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marco Salvini, MD
- Email: marco.salvini@asst-settelaghi.it
Study Locations
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Alessandria, Italy
- Recruiting
- SC Ematologia Ospedale SS Antonio e Biagio e Cesare Arrigo
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Contact:
- Marco Ladetto, MD
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Ancona, Italy
- Recruiting
- UOC Ematologia, Ospedali Riuniti
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Ascoli Piceno, Italy
- Recruiting
- UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni
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Aviano, Italy
- Recruiting
- SC Oncologia Medica, CRO
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Bari, Italy
- Recruiting
- SC Ematologia, Policlinico Bari
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Bari, Italy
- Recruiting
- UOC Ematologia, I.R.C.C.S Istituto Tumori Giovanni Paolo II
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Biella, Italy
- Recruiting
- SSD Ematologia, Ospedale degli Infermi
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Contact:
- Anna Conconi, MD
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Bologna, Italy
- Recruiting
- UOC Ematologia, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi,
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Contact:
- Michele Cavo, MD
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Bolzano, Italy
- Recruiting
- Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano
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Contact:
- Atto Billio, MD
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Brescia, Italy
- Recruiting
- UO Ematologia e CTMO, ASST Spedali Civili
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Contact:
- Chiara Cattaneo, MD
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Busto Arsizio, Italy
- Recruiting
- UOC Onco-Ematologia ASST Valle Olona
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Contact:
- Fabrizio Ciambelli, MD
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Cagliari, Italy
- Recruiting
- SC Ematologia e CTMO AZIENDA OSPEDALIERA "G. BROTZU" - OSPEDALE ONCOLOGICO BUSINCO
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Contact:
- Giorgio La Nasa, MD
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Catania, Italy
- Recruiting
- UOC Ematologia, AOU Policlinico Vittorio Emanuele
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Contact:
- Francesco Di Raimondo, MD
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Como, Italy
- Recruiting
- Ematologia, Ospedale Valduce
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Contact:
- Mauro Turrini, MD
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Cosenza, Italy
- Recruiting
- UOC Ematologia, Azienda Ospedaliera di Cosenza
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Contact:
- Massimo Gentile, MD
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Cremona, Italy
- Recruiting
- UO Ematologia e CTMO, ASST Cremona
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Contact:
- Alfredo Molteni, MD
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Cuneo, Italy
- Recruiting
- SC Ematologia Ospedale S. Croce
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Contact:
- Massimo Massaia, MD
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Ferrara, Italy
- Recruiting
- UOC, Ematologia Azienda Ospedaliero Universitaria Arcispedale S. Anna
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Contact:
- Antonio Cuneo, MD
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Firenze, Italy
- Recruiting
- S.O.D. Ematologia, Azienda Ospedaliero Universitaria Careggi
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Contact:
- Alberto Bosi, MD
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Foggia, Italy
- Recruiting
- UOC Ematologia, Policlinico Ospedali Riuniti
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Contact:
- Celestino Ferrandina, MD
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Forlì, Italy
- Recruiting
- IRST-IRCC di Meldola
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Genova, Italy
- Recruiting
- UO Ematologia, Ospedale Policlinico S.Martino IRCCS
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Contact:
- Roberto Lemoli, MD
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Genova, Italy
- Recruiting
- UO Ematologia, Ospedale Policlinico San Martino
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Lecce, Italy
- Recruiting
- UOC di Ematologia e Trapianto di Cellule Staminali, P.O. Vito Fazzi
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Legnano, Italy
- Recruiting
- UOC di Ematologia, Ospedale di Legnano
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Contact:
- Alessandro Corso, MD
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Livorno, Italy
- Recruiting
- UO Dipartimento di Ematologia, USL 6
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Contact:
- Annarosa Cuccaro, MD
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Lodi, Italy
- Recruiting
- UOC Oncologia ASST Lodi
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Contact:
- Alessandro Inzoli, MD
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Messina, Italy
- Recruiting
- UOC Ematologia Azienda Ospedaliera Universitaria "G.Martino"
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Contact:
- Caterina Musolino, MD
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Mestre, Italy
- Recruiting
- UO Ematologia, Ospedale dell'Angelo di Mestre
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Contact:
- Renato Bassan, MD
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Milano, Italy
- Recruiting
- Ematologia, IEO
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Contact:
- Corrado Tarella, MD
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Milano, Italy
- Recruiting
- SC Ematologia, Istituto Nazionale dei Tumori
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Contact:
- Paolo Corradini, MD
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Milano, Italy
- Recruiting
- SC Ematologia, Ospedale Niguarda
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Contact:
- Roberto Cairoli, MD
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Milano, Italy
- Recruiting
- UO Ematologia, IRCCS Ospedale San Raffaele
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Contact:
- Fabio Ciceri, MD
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Milano, Italy
- Recruiting
- UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco
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Contact:
- Augusto Federici, MD
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Milano, Italy
- Recruiting
- UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Modena, Italy
- Recruiting
- UO Ematologia Policlinico di Modena
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Contact:
- Mario Luppi, MD
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Monza, Italy
- Recruiting
- UOC Ematologia, Ospedale S. Gerardo
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Contact:
- Carlo Gambacorti Passerini, MD
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Napoli, Italy
- Recruiting
- SC Ematologia Istituto Nazionale Tumori - IRCCS "Fondazione G. Pascale",
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Contact:
- Antonio Pinto, MD
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Napoli, Italy
- Recruiting
- UOC Ematologia e Trapianti di Midollo, AOU Federico II
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Contact:
- Fabrizio Pane, MD
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Napoli, Italy
- Recruiting
- UOC Ematologia, Ospedale Antonio Cardarelli
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Contact:
- Felicetto Ferrara, MD
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Novara, Italy
- Recruiting
- UOC Ematologia, Azienda Ospedaliero-Universitaria Maggiore della Carità
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Contact:
- Gianluca Gaidano, MD
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Orbassano, Italy
- Recruiting
- Ospedale San Luigi Gonzaga
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Padova, Italy
- Recruiting
- Ematologia Azienda Ospedaliera di Padova
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Contact:
- Giampietro Semenzato, MD
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Palermo, Italy
- Recruiting
- UO Ematologia, Policlinico Paolo Giaccone
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Parma, Italy
- Recruiting
- UOC Ematologia e CTMO, Azienda Ospedaliero-Universitaria di Parma
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Contact:
- Nicola Giuliani, MD
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Pavia, Italy
- Recruiting
- SC Ematologia, Fondazione IRCCS Policlinico San Matteo
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Perugia, Italy
- Recruiting
- SC Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera di Perugia
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Contact:
- Brunangelo Falini, MD
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Pesaro, Italy
- Recruiting
- UO Ematologia e CTMO, Azienda Ospedaliera Ospedali Riuniti
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Contact:
- Giuseppe Visani, MD
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Pescara, Italy
- Recruiting
- UOC di Ematologia, Ospedale Civile Spirito Santo
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Contact:
- Antonio Spadano, MD
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Piacenza, Italy
- Recruiting
- UO Ematologia e CTMO, Presidio Ospedaliero di Piacenza
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Contact:
- Daniele Vallisa, MD
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Pisa, Italy
- Recruiting
- UO Ematologia, AOU Pisana- Santa Chiara
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Contact:
- Sara Galimberti, MD
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Ravenna, Italy
- Recruiting
- UO Ematologia dell'Ospedale Santa Maria delle Croci
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Reggio Calabria, Italy
- Recruiting
- UOC Ematologia, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
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Contact:
- Bruno Martino, MD
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Reggio Emilia, Italy
- Recruiting
- SC Ematologia, Arcispedale Santa Maria Nuova
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Contact:
- Francesco Merli, MD
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Rimini, Italy
- Recruiting
- UO Ematologia, Ospedale Infermi
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Contact:
- Patrizia Tosi, MD
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Roma, Italy
- Recruiting
- AOU Azienda Ospedaliera Universitaria Sant'Andrea
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Contact:
- Agostino Tafuri, MD
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Roma, Italy
- Recruiting
- IFO - Ematologia e Trapianto Cellule -Istituto Nazionale del Cancro di Regina Elena
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Contact:
- Francesco Marchesi, MD
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Roma, Italy
- Recruiting
- SC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Contact:
- Livio Pagano, MD
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Roma, Italy
- Recruiting
- UO Ematologia e Trapianti di Cellule Staminali, A.O. S. Camillo-Forlanini
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Contact:
- Luigi Rigacci, MD
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Roma, Italy
- Recruiting
- UO Ematologia, Policlinico Tor Vergata
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Contact:
- Adriano Venditti, MD
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Roma, Italy
- Recruiting
- UOC Ematologia e trapianto di cellule staminali, Policlinico Universitario Campus Bio-Medico
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Contact:
- Giuseppe Avvisati, MD
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Roma, Italy
- Recruiting
- UOC Ematologia Policlinico Umberto I
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Roma, Italy
- Recruiting
- UOC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Roma, Italy
- Recruiting
- UOC Ematologia- Azienda Ospedaliera San Giovanni Addolorata
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Contact:
- Laura Cudillo, MD
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Rozzano, Italy
- Recruiting
- UO Ematologia, Istituto Clinico Humanitas
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Contact:
- Matteo Della Porta, MD
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Salerno, Italy
- Recruiting
- UOC Ematologia e centro trapianti cellule staminali emopoietiche, AOU San Giovanni Di Dio e Ruggi D'aragona
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Sanremo, Italy
- Recruiting
- Ematologia ASL Imperiese
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Contact:
- Tullio Calzamiglia, MD
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Savona, Italy
- Recruiting
- Medicina Interna ed Ematologia, Asl 1
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Contact:
- Marina Cavaliere, MD
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Siena, Italy
- Recruiting
- UOC Ematologia, Policlinico Santa Maria alle Scotte
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Taranto, Italy
- Recruiting
- UOC Ematologia e Trapianto Midollo Osseo, Ospedale S. G. Moscati
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Contact:
- Patrizio Mazza, MD
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Torino, Italy
- Recruiting
- SCDU Ematologia e terapie cellulari, Ospedale Mauriziano Umberto I
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Contact:
- Carmen Fava, MD
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Torino, Italy
- Recruiting
- UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
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Contact:
- Alessandro Busca, MD
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Treviso, Italy
- Recruiting
- UO Ematologia, Ospedale Civili Ca' Foncello
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Trieste, Italy
- Recruiting
- SC Ematologia, Azienda sanitaria universitaria Giuliano Isontina
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Udine, Italy
- Recruiting
- Clinica Ematologia, Azienda Ospedaliera-Universitaria Santa Maria della Misericordia
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Contact:
- Renato Fanin, MD
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Varese, Italy, 21100
- Recruiting
- UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi
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Verona, Italy
- Recruiting
- UOC Ematologia, Azienda Ospedaliera Integrata di Verona
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Contact:
- Carlo Visco, MD
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Vicenza, Italy
- Recruiting
- UOC Ematologia, Ospedale San Bortolo
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Contact:
- Marco Ruggeri, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Hematological diseases, other than hematological malignancies.
- SARS-CoV-2 negative test.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate mortality.
Time Frame: At 2 months from study initiation
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The percentage of HM patients with COVID-19 who died.
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At 2 months from study initiation
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To evaluate potential predictive biochemical parameters of mortality.
Time Frame: At 2 months from study initiation
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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.
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At 2 months from study initiation
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To evaluate potential predictive HM-related parameters of mortality.
Time Frame: At 2 months from study initiation
|
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
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To evaluate COVID severity as predictive parameter of mortality.
Time Frame: At 2 months from study initiation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity
Time Frame: At 6 months from study initiation
|
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)
|
At 6 months from study initiation
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Definition of complete clinical picture of COVID-19 in HM
Time Frame: At 2 months from study initiation
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Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.
|
At 2 months from study initiation
|
Evolution of HM
Time Frame: At 2 months from study initiation
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Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.
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At 2 months from study initiation
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To evaluate admission to ICU requiring mechanical ventilation or death per characteristics
Time Frame: At 2 months from study initiation
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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).
|
At 2 months from study initiation
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Viral dynamics in infected HM patients
Time Frame: At 12 months from study initiation
|
At 12 months from study initiation
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-COVID19-Italy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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