key: cord-0789559-w5398qqu
authors: Bandera, Alessandra; Aliberti, Stefano; Gualtierotti, Roberta; Baldini, Marina; Blasi, Francesco; Cesari, Matteo; Costantino, Giorgio; Fracanzani, Anna Ludovica; Gori, Andrea; Montano, Nicola; Monzani, Valter; Nobili, Alessandro; Peyvandi, Flora; Pesenti, Antonio; Prati, Daniele; Valenti, Luca; Fusetti, Giuliana; Scudeller, Luigia; Bosari, Silvano
title: COVID-19 network: the response of an Italian reference Institute to research challenges about a new pandemia
date: 2020-06-30
journal: Clin Microbiol Infect
DOI: 10.1016/j.cmi.2020.06.028
sha: 8d6e38d42476d4a24aa540b7694fc31b80377701
doc_id: 789559
cord_uid: w5398qqu

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Alessandra Bandera MD, PhD 1,2* , Stefano Aliberti MD 2,3 , Roberta Gualtierotti MD 2,4 , Marina 3

Baldini MD 5 , Francesco Blasi MD 2,3 , Matteo Cesari MD, PhD 6,7 , Giorgio Costantino MD 7, 8 , Anna 4 Ludovica Fracanzani MD 2,9 , Andrea Gori MD 1,2 , Nicola Montano MD 7,10 , Valter Monzani MD 11 , 5

Alessandro Nobili MD 12 To the Editor, 1 on February 21 st , 2020, the first case of SARS-CoV-2 transmission within the Italian borders, with 2 no apparent link with imported cases, was reported (1). The number of confirmed infections has 3 therefore multiplied, and Italy is currently the second European country by number of recorded 4 cases, with Lombardy, the most affected region (2). The regional health service has been 5 reorganized, and COVID-19 units have rapidly been developed in most regional hospitals (3). 6 COVID-19 outbreak also represents a significant challenge for the organization of translational 7 research activity in a coordinated and multi-disciplinary approach. 8 interventional studies. The Ethical Committee meets on a daily basis to rapidly assess the scientific 20 and ethical value of studies. Moreover, we have opened the Registry to several Regional and 21 National centers to allow collection of data also for centers with limited research resources, and to 22 create a Network of different hospital units. To date, more than 984 patients overall have been 23 enrolled (641 observed at the coordinating centre, Policlinico Hospital), and more than 1000 24 biological samples have been stored. Moreover, researchers from this study group already produced

The COVID-19 network will also provide a platform for future national and international 1 multicenter studies and investigator-initiated satellite projects: we are planning not only 2 epidemiological studies, but also precision medicine studies with a multidisciplinary approach, 3 including immunology, virology, and omics approaches. To the best of our knowledge, only 3 4 others multi-centric registries are currently ongoing at a National level, focused on neonates, 5 children and intensive-care units. 6

Evaluating our experience as Reference Hospital facing COVID-19 epidemic, we think that the 7 tools that have facilitated research activities have been: (i) strong leadership in different disciplines 8 which proved fundamental in the management of COVID-19 patients; (ii) IT resources, such as 9

RedCap, i2b2, tele-conferencing systems; (iii) coordination between different research units; (iv) 10 involvement of data manager and technical personnel dedicated to data collection, sample 11 collection, processing and storage; v) collaboration with others Research Institutes and clinical 12 centers; vi) strong motivation and altruism of both clinical, research and support staff. 13

On the other hand, administrative issues linked to documents generation and approval often acted as 14 barriers. Furthermore, limited data available in clinical electronic records required large human 15 resources (data managers) to input high-granularity data. Finally, conducting interventional 16 pharmacological studies proved difficult, owing to the limited preclinical and clinical data on many 17 proposed drugs, and to centralization at national level of drug trials. 18

To fully exploit the potential of our registry, data sharing will be crucial: consistently with similar 19 initiatives at the national and international level, our data will be available for projects proposed by 20 basic and clinical research groups worldwide. 

Respiratory Unit and Cystic Fibrosis Adult Center: Francesco Blasi, Stefano Aliberti

Acute Internal Medicine: Valter Monzani

Internal Medicine: Marina Baldini

LS drafted the manuscript, all authors revised the manuscript 14 and contributed to intellectual content

Review of "First cases of coronavirus disease 2019 2 (COVID 19) in the WHO European Region

Coronavirus COVID-19 global cases by the Center for Systems Science and Engineering 5 (CSSE) at Johns Hopkins

Critical Care Utilization for the COVID-19 Outbreak in

Early Experience and Forecast During an Emergency Response

Defining the Epidemiology of Covid-19 -Studies Needed

We thank the health care workers of our Hospital, for their professional and indefatigable 8 commitment to COVID-19 patients' care, in these difficult times. 9We are also grateful to all the data managers, study coordinators, physicians, lab technician 10 involved in data and sample collection. 11We also thank all the personnel of Clinical Trial Center, Grant Office, IT service, and Human 12Resources of Policlinico di Milano for their constant support.