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.


Journal

Pharmacological research
ISSN: 1096-1186
Titre abrégé: Pharmacol Res
Pays: Netherlands
ID NLM: 8907422

Informations de publication

Date de publication:
08 2020
Historique:
received: 03 05 2020
revised: 03 05 2020
accepted: 04 05 2020
pubmed: 15 5 2020
medline: 21 7 2020
entrez: 15 5 2020
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 32407959
pii: S1043-6618(20)31207-X
doi: 10.1016/j.phrs.2020.104899
pmc: PMC7212963
pii:
doi:

Substances chimiques

Antiviral Agents 0
remdesivir 3QKI37EEHE
Adenosine Monophosphate 415SHH325A
Transaminases EC 2.6.1.-
Alanine OF5P57N2ZX

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

104899

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

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Auteurs

Spinello Antinori (S)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy. Electronic address: spinello.antinori@unimi.it.

Maria Vittoria Cossu (MV)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Anna Lisa Ridolfo (AL)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Roberto Rech (R)

Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.

Cecilia Bonazzetti (C)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.

Gabriele Pagani (G)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.

Guido Gubertini (G)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Massimo Coen (M)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Carlo Magni (C)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Antonio Castelli (A)

Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.

Beatrice Borghi (B)

Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.

Riccardo Colombo (R)

Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.

Riccardo Giorgi (R)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Elena Angeli (E)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Davide Mileto (D)

Diagnostic Services, Clinical Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli-Sacco, Milan, Italy.

Laura Milazzo (L)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Stefania Vimercati (S)

Pharmaceutical Department, ASST Fatebenefratelli-Sacco, Milan, Italy.

Martina Pellicciotta (M)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Mario Corbellino (M)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Alessandro Torre (A)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Stefano Rusconi (S)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Letizia Oreni (L)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Maria Rita Gismondo (MR)

Diagnostic Services, Clinical Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli-Sacco, Milan, Italy.

Andrea Giacomelli (A)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Luca Meroni (L)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Giuliano Rizzardini (G)

Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Massimo Galli (M)

Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

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