TY - JOUR
T1 - The clinical and translational research activities at the INT – IRCCS “Fondazione Pascale” cancer center (Naples, Italy) during the COVID-19 pandemic
AU - and the INT-Pascale COVID-19 Crisis Unit
AU - Buonaguro, Franco M.
AU - Botti, Gerardo
AU - Ascierto, Paolo Antonio
AU - Pignata, Sandro
AU - Ionna, Franco
AU - Delrio, Paolo
AU - Petrillo, Antonella
AU - Cavalcanti, Ernesta
AU - Di Bonito, Maurizio
AU - Perdonà, Sisto
AU - De Laurentiis, Michelino
AU - Fiore, Francesco
AU - Palaia, Raffaele
AU - Izzo, Francesco
AU - D’Auria, Stefania
AU - Rossi, Virginia
AU - Menegozzo, Simona
AU - Piccirillo, Mauro
AU - Celentano, Egidio
AU - Cuomo, Arturo
AU - Normanno, Nicola
AU - Tornesello, Maria Lina
AU - Saviano, Rocco
AU - Barberio, Daniela
AU - Buonaguro, Luigi
AU - Giannoni, Giovanni
AU - Muto, Paolo
AU - Miscio, Leonardo
AU - Bianchi, Attilio A.M.
AU - Cascella, Marco
AU - Ciavolino, Paolo
AU - Correra, Marco
AU - Di Franco, Rossella
AU - Di Pietro, Gaetano
AU - Franco, Pierluigi
AU - Grizzuti, Giovanni
AU - Labonia, Francesco
AU - Russo, Sergio
AU - Salzano, Giovanni
N1 - Funding Information:
This article represents an Institutional report of the internal reorganization implemented in order to continue the Cancer treatment activity, at the CCC INT-IRCCS “Fondazione Pascale” Cancer Center in Naples, and to protect from COVID-19 infection the hospitalized cancer patients and those attending the outpatient clinics, their caregivers and the Institute health workers. The established COVID-19 crisis units prevented the transmission of the infection to the hospitalized “fragile” cancer patients (particularly onco-hematological patients), immediately intercepting COVID-19 positive patients at the hospital admission, promptly identifying COVID-19 positive patients (n = 2), and transferring them to a temporary quarantine section of the semi-intensive care unit, as well as health workers infected outside of the Institute and activation of the mandatory home quarantine procedure. The Institute quick reaction at the mounting epidemics, even in absence of COVID-19 patients, achieved highly relevant research results and in particular highlighted the anaphylactoid component of the Acute Respiratory Distress Syndrome (ARDS) and the possibility of introducing anti-IL-6/IL-6R axis available drugs in particular Tocilizumab during the cytokine storm with drastic reduction of the Intensive Care Units (ICU) occupancy and the following intubation (9–11). This innovative treatment approach led to the elaboration of the Phase II clinical trial TOCIVID-19 [EudraCT number 2020–001110-38 – ClinicaltTrials.gov NCT04317092] approved by AIFA (the Italian Drug Agency) on March 17th [], representing the first non-profit anti-COVID-19 Italian clinical trial []. A similar study with a different anti-IL6R mAb (Sarilumab, distributed by Regeneron-Sanofi) was announced by the company on March 16th [] and by FDA on March 19th []. Since then, several research activities, particularly in the translational area, were coordinated by the Scientific Director, Dr. Gerardo Botti, with participation at the COVID-19 research programs launched and funded by the Campania Regional Government and by the Italian Ministry of Health. In this context other molecules were identified and their repurposing studied in particular Sofosbuvir [, ] along with Favipiravir and Camostat. Moreover, under the auspices of the Director General, Dr. Attilio Bianchi, who strongly supported long-term post-treatment and inter-treatment cancer health programs, an innovative home-based remote monitoring was elaborated and implemented with development of digital device and an appropriate IT platform for h24 collection of COVID-related vital date (including body temperature, SpO and ECG). This strategy allowed the home monitoring of COVID-19 positive subjects at risk of further progression to severe respiratory distress. 2
Publisher Copyright:
© 2020, The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12
Y1 - 2020/12
N2 - COVID-19 pandemic following the outbreak in China and Western Europe, where it finally lost the momentum, is now devastating North and South America. It has not been identified the reason and the molecular mechanisms of the two different patterns of the pulmonary host responses to the virus from a minimal disease in young subjects to a severe distress syndrome (ARDS) in older subjects, particularly those with previous chronic diseases (including diabetes) and cancer. The Management of the Istituto Nazionale Tumori - IRCCS “Fondazione Pascale” in Naples (INT-Pascale), along with all Health professionals decided not to interrupt the treatment of those hospitalized and to continue, even if after a careful triage in order not to allow SARS-CoV-2 positive subjects to access, to take care of cancer patients with serious conditions. Although very few (n = 3) patients developed a symptomatic COVID-19 and required the transfer to a COVID-19 area of the Institute, no patients died during the hospitalization and completed their oncology treatment. Besides monitoring of the patients, all employees of the Institute (physicians, nurses, researchers, lawyers, accountants, gatekeepers, guardians, janitors) have been tested for a possible exposure. Personnel identified as positive, has been promptly subjected to home quarantine and subdued to health surveillance. One severe case of respiratory distress has been reported in a positive employees and one death of a family member. Further steps to home monitoring of COVID-19 clinical course have been taken with the development of remote Wi-Fi connected digital devices for the detection of early signs of respiratory distress, including heart rate and oxygen saturation. In conclusion cancer care has been performed and continued safely also during COVID-19 pandemic and further remote home strategies are in progress to ensure the appropriate monitoring of cancer patients.
AB - COVID-19 pandemic following the outbreak in China and Western Europe, where it finally lost the momentum, is now devastating North and South America. It has not been identified the reason and the molecular mechanisms of the two different patterns of the pulmonary host responses to the virus from a minimal disease in young subjects to a severe distress syndrome (ARDS) in older subjects, particularly those with previous chronic diseases (including diabetes) and cancer. The Management of the Istituto Nazionale Tumori - IRCCS “Fondazione Pascale” in Naples (INT-Pascale), along with all Health professionals decided not to interrupt the treatment of those hospitalized and to continue, even if after a careful triage in order not to allow SARS-CoV-2 positive subjects to access, to take care of cancer patients with serious conditions. Although very few (n = 3) patients developed a symptomatic COVID-19 and required the transfer to a COVID-19 area of the Institute, no patients died during the hospitalization and completed their oncology treatment. Besides monitoring of the patients, all employees of the Institute (physicians, nurses, researchers, lawyers, accountants, gatekeepers, guardians, janitors) have been tested for a possible exposure. Personnel identified as positive, has been promptly subjected to home quarantine and subdued to health surveillance. One severe case of respiratory distress has been reported in a positive employees and one death of a family member. Further steps to home monitoring of COVID-19 clinical course have been taken with the development of remote Wi-Fi connected digital devices for the detection of early signs of respiratory distress, including heart rate and oxygen saturation. In conclusion cancer care has been performed and continued safely also during COVID-19 pandemic and further remote home strategies are in progress to ensure the appropriate monitoring of cancer patients.
KW - ARDS
KW - Cancer center
KW - COVID-19
KW - IL-6
KW - Italy
KW - Pascale
KW - SARS-CoV-2
KW - Tocilizumab
UR - http://www.scopus.com/inward/record.url?scp=85096600270&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096600270&partnerID=8YFLogxK
U2 - 10.1186/s13027-020-00330-7
DO - 10.1186/s13027-020-00330-7
M3 - Article
AN - SCOPUS:85096600270
SN - 1750-9378
VL - 15
JO - Infectious Agents and Cancer
JF - Infectious Agents and Cancer
IS - 1
M1 - 69
ER -