Tags

Type your tag names separated by a space and hit enter

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.
Pharmacol Res. 2020 08; 158:104899.PR

Abstract

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.

Authors+Show Affiliations

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.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.Intensive Care Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Diagnostic Services, Clinical Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Pharmaceutical Department, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Diagnostic Services, Clinical Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli-Sacco, Milan, Italy.Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.

Pub Type(s)

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

Language

eng

PubMed ID

32407959

Citation

Antinori, Spinello, et al. "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." Pharmacological Research, vol. 158, 2020, p. 104899.
Antinori S, Cossu MV, Ridolfo AL, et al. 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. Pharmacol Res. 2020;158:104899.
Antinori, S., Cossu, M. V., Ridolfo, A. L., Rech, R., Bonazzetti, C., Pagani, G., Gubertini, G., Coen, M., Magni, C., Castelli, A., Borghi, B., Colombo, R., Giorgi, R., Angeli, E., Mileto, D., Milazzo, L., Vimercati, S., Pellicciotta, M., Corbellino, M., ... Galli, M. (2020). 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. Pharmacological Research, 158, 104899. https://doi.org/10.1016/j.phrs.2020.104899
Antinori S, et al. 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. Pharmacol Res. 2020;158:104899. PubMed PMID: 32407959.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Antinori,Spinello, AU - Cossu,Maria Vittoria, AU - Ridolfo,Anna Lisa, AU - Rech,Roberto, AU - Bonazzetti,Cecilia, AU - Pagani,Gabriele, AU - Gubertini,Guido, AU - Coen,Massimo, AU - Magni,Carlo, AU - Castelli,Antonio, AU - Borghi,Beatrice, AU - Colombo,Riccardo, AU - Giorgi,Riccardo, AU - Angeli,Elena, AU - Mileto,Davide, AU - Milazzo,Laura, AU - Vimercati,Stefania, AU - Pellicciotta,Martina, AU - Corbellino,Mario, AU - Torre,Alessandro, AU - Rusconi,Stefano, AU - Oreni,Letizia, AU - Gismondo,Maria Rita, AU - Giacomelli,Andrea, AU - Meroni,Luca, AU - Rizzardini,Giuliano, AU - Galli,Massimo, Y1 - 2020/05/11/ PY - 2020/05/03/received PY - 2020/05/03/revised PY - 2020/05/04/accepted PY - 2020/5/15/pubmed PY - 2020/7/21/medline PY - 2020/5/15/entrez KW - COVID-19 KW - Remdesivir KW - SARS-CoV-2 SP - 104899 EP - 104899 JF - Pharmacological research JO - Pharmacol Res VL - 158 N2 - 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. SN - 1096-1186 UR - https://www.unboundmedicine.com/medline/citation/32407959/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1043-6618(20)31207-X DB - PRIME DP - Unbound Medicine ER -