Cargando…

Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status

SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of rem...

Descripción completa

Detalles Bibliográficos
Autores principales: Antinori, Spinello, Cossu, Maria Vittoria, Ridolfo, Anna Lisa, Rech, Roberto, Bonazzetti, Cecilia, Pagani, Gabriele, Gubertini, Guido, Coen, Massimo, Magni, Carlo, Castelli, Antonio, Borghi, Beatrice, Colombo, Riccardo, Giorgi, Riccardo, Angeli, Elena, Mileto, Davide, Milazzo, Laura, Vimercati, Stefania, Pellicciotta, Martina, Corbellino, Mario, Torre, Alessandro, Rusconi, Stefano, Oreni, Letizia, Gismondo, Maria Rita, Giacomelli, Andrea, Meroni, Luca, Rizzardini, Giuliano, Galli, Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212963/
https://www.ncbi.nlm.nih.gov/pubmed/32407959
http://dx.doi.org/10.1016/j.phrs.2020.104899
_version_ 1783531706652819456
author Antinori, Spinello
Cossu, Maria Vittoria
Ridolfo, Anna Lisa
Rech, Roberto
Bonazzetti, Cecilia
Pagani, Gabriele
Gubertini, Guido
Coen, Massimo
Magni, Carlo
Castelli, Antonio
Borghi, Beatrice
Colombo, Riccardo
Giorgi, Riccardo
Angeli, Elena
Mileto, Davide
Milazzo, Laura
Vimercati, Stefania
Pellicciotta, Martina
Corbellino, Mario
Torre, Alessandro
Rusconi, Stefano
Oreni, Letizia
Gismondo, Maria Rita
Giacomelli, Andrea
Meroni, Luca
Rizzardini, Giuliano
Galli, Massimo
author_facet Antinori, Spinello
Cossu, Maria Vittoria
Ridolfo, Anna Lisa
Rech, Roberto
Bonazzetti, Cecilia
Pagani, Gabriele
Gubertini, Guido
Coen, Massimo
Magni, Carlo
Castelli, Antonio
Borghi, Beatrice
Colombo, Riccardo
Giorgi, Riccardo
Angeli, Elena
Mileto, Davide
Milazzo, Laura
Vimercati, Stefania
Pellicciotta, Martina
Corbellino, Mario
Torre, Alessandro
Rusconi, Stefano
Oreni, Letizia
Gismondo, Maria Rita
Giacomelli, Andrea
Meroni, Luca
Rizzardini, Giuliano
Galli, Massimo
author_sort Antinori, Spinello
collection PubMed
description SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of remdesivir, which was conducted at Luigi Sacco Hospital, Milan, Italy, between February 23 and March 20, 2020, involved patients with SARS-CoV-2 pneumonia aged ≥18 years undergoing mechanical ventilation or with an oxygen saturation level of ≤94 % in air or a National Early Warning Score 2 of ≥4. The primary outcome was the change in clinical status based on a 7-category ordinal scale (1 = not hospitalised, resuming normal daily activities; 7 = deceased). The 35 patients enrolled from February 23 to March 20, 2020, included 18 in intensive care unit (ICU), and 17 in our infectious diseases ward (IDW). The 10-day course of remdesivir was completed by 22 patients (63 %) and discontinued by 13, of whom eight (22.8 %) discontinued because of adverse events. The median follow-up was 39 days (IQR 25–44). At day 28, 14 (82.3 %) patients from IDW were discharged, two were still hospitalized and one died (5.9 %), whereas in ICU 6 (33.3 %) were discharged, 8 (44.4 %) patients died, three (16.7 %) were still mechanically ventilated and one (5.6 %) was improved but still hospitalized. Hypertransaminasemia and acute kidney injury were the most frequent severe adverse events observed (42.8 % and 22.8 % of the cases, respectively). Our data suggest that remdesivir can benefit patients with SARS-CoV-2 pneumonia hospitalised outside ICU where clinical outcome was better and adverse events are less frequently observed. Ongoing randomised controlled trials will clarify its real efficacy and safety, who to treat, and when.
format Online
Article
Text
id pubmed-7212963
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Elsevier Ltd.
record_format MEDLINE/PubMed
spelling pubmed-72129632020-05-11 Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status Antinori, Spinello Cossu, Maria Vittoria Ridolfo, Anna Lisa Rech, Roberto Bonazzetti, Cecilia Pagani, Gabriele Gubertini, Guido Coen, Massimo Magni, Carlo Castelli, Antonio Borghi, Beatrice Colombo, Riccardo Giorgi, Riccardo Angeli, Elena Mileto, Davide Milazzo, Laura Vimercati, Stefania Pellicciotta, Martina Corbellino, Mario Torre, Alessandro Rusconi, Stefano Oreni, Letizia Gismondo, Maria Rita Giacomelli, Andrea Meroni, Luca Rizzardini, Giuliano Galli, Massimo Pharmacol Res Article SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of remdesivir, which was conducted at Luigi Sacco Hospital, Milan, Italy, between February 23 and March 20, 2020, involved patients with SARS-CoV-2 pneumonia aged ≥18 years undergoing mechanical ventilation or with an oxygen saturation level of ≤94 % in air or a National Early Warning Score 2 of ≥4. The primary outcome was the change in clinical status based on a 7-category ordinal scale (1 = not hospitalised, resuming normal daily activities; 7 = deceased). The 35 patients enrolled from February 23 to March 20, 2020, included 18 in intensive care unit (ICU), and 17 in our infectious diseases ward (IDW). The 10-day course of remdesivir was completed by 22 patients (63 %) and discontinued by 13, of whom eight (22.8 %) discontinued because of adverse events. The median follow-up was 39 days (IQR 25–44). At day 28, 14 (82.3 %) patients from IDW were discharged, two were still hospitalized and one died (5.9 %), whereas in ICU 6 (33.3 %) were discharged, 8 (44.4 %) patients died, three (16.7 %) were still mechanically ventilated and one (5.6 %) was improved but still hospitalized. Hypertransaminasemia and acute kidney injury were the most frequent severe adverse events observed (42.8 % and 22.8 % of the cases, respectively). Our data suggest that remdesivir can benefit patients with SARS-CoV-2 pneumonia hospitalised outside ICU where clinical outcome was better and adverse events are less frequently observed. Ongoing randomised controlled trials will clarify its real efficacy and safety, who to treat, and when. Elsevier Ltd. 2020-08 2020-05-11 /pmc/articles/PMC7212963/ /pubmed/32407959 http://dx.doi.org/10.1016/j.phrs.2020.104899 Text en © 2020 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Antinori, Spinello
Cossu, Maria Vittoria
Ridolfo, Anna Lisa
Rech, Roberto
Bonazzetti, Cecilia
Pagani, Gabriele
Gubertini, Guido
Coen, Massimo
Magni, Carlo
Castelli, Antonio
Borghi, Beatrice
Colombo, Riccardo
Giorgi, Riccardo
Angeli, Elena
Mileto, Davide
Milazzo, Laura
Vimercati, Stefania
Pellicciotta, Martina
Corbellino, Mario
Torre, Alessandro
Rusconi, Stefano
Oreni, Letizia
Gismondo, Maria Rita
Giacomelli, Andrea
Meroni, Luca
Rizzardini, Giuliano
Galli, Massimo
Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title_full Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title_fullStr Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title_full_unstemmed Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title_short Compassionate remdesivir treatment of severe Covid-19 pneumonia in intensive care unit (ICU) and Non-ICU patients: Clinical outcome and differences in post-treatment hospitalisation status
title_sort compassionate remdesivir treatment of severe covid-19 pneumonia in intensive care unit (icu) and non-icu patients: clinical outcome and differences in post-treatment hospitalisation status
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212963/
https://www.ncbi.nlm.nih.gov/pubmed/32407959
http://dx.doi.org/10.1016/j.phrs.2020.104899
work_keys_str_mv AT antinorispinello compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT cossumariavittoria compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT ridolfoannalisa compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT rechroberto compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT bonazzetticecilia compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT paganigabriele compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT gubertiniguido compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT coenmassimo compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT magnicarlo compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT castelliantonio compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT borghibeatrice compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT colomboriccardo compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT giorgiriccardo compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT angelielena compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT miletodavide compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT milazzolaura compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT vimercatistefania compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT pellicciottamartina compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT corbellinomario compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT torrealessandro compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT rusconistefano compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT oreniletizia compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT gismondomariarita compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT giacomelliandrea compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT meroniluca compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT rizzardinigiuliano compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus
AT gallimassimo compassionateremdesivirtreatmentofseverecovid19pneumoniainintensivecareuniticuandnonicupatientsclinicaloutcomeanddifferencesinposttreatmenthospitalisationstatus