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http://hdl.handle.net/2445/174122
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DC Field | Value | Language |
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dc.contributor.author | Goldman, Jason D. | - |
dc.contributor.author | Lye, David C.B. | - |
dc.contributor.author | Hui, David S. | - |
dc.contributor.author | Marks, Kristen M. | - |
dc.contributor.author | Bruno, Raffaele | - |
dc.contributor.author | Montejano, Rocio | - |
dc.contributor.author | Spinner, Christoph D. | - |
dc.contributor.author | Galli, Massimo | - |
dc.contributor.author | Ahn, Mi‑Young | - |
dc.contributor.author | Nahass, Ronald G. | - |
dc.contributor.author | Chen, Yao-Shen | - |
dc.contributor.author | SenGupta, Devi | - |
dc.contributor.author | Hyland, Robert H. | - |
dc.contributor.author | Osinusi, Anu O. | - |
dc.contributor.author | Cao, Huyen | - |
dc.contributor.author | Blair, Christiana | - |
dc.contributor.author | Wei, Xuelian | - |
dc.contributor.author | Gaggar, Anuj | - |
dc.contributor.author | Brainard, Diana M. | - |
dc.contributor.author | Towner, William J. | - |
dc.contributor.author | Muñoz Gutiérrez, José | - |
dc.contributor.author | Mullane, Kathleen M. | - |
dc.contributor.author | Marty, Francisco M. | - |
dc.contributor.author | Tashima, Karen T. | - |
dc.contributor.author | Diaz, George | - |
dc.contributor.author | Subramanian, Aruna | - |
dc.contributor.author | GS-US-540-5773 Investigators | - |
dc.date.accessioned | 2021-02-22T10:53:04Z | - |
dc.date.available | 2021-02-22T10:53:04Z | - |
dc.date.issued | 2020-05-27 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/174122 | - |
dc.description.abstract | Background: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Methods: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. Results: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). Conclusions: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.). | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa2015301 | - |
dc.relation.ispartof | New England Journal of Medicine, 2020, vol. 383, p. 1827-1837 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa2015301 | - |
dc.rights | (c) Massachusetts Medical Society, 2020 | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | COVID-19 | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.other | COVID-19 | - |
dc.subject.other | Clinical trials | - |
dc.title | Remdesivir for 5 or 10 Days in Patients With Severe Covid-19 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 701486 | - |
dc.date.updated | 2021-02-22T10:53:04Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 32459919 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) Articles publicats en revistes (ISGlobal) |
Files in This Item:
File | Description | Size | Format | |
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701486.pdf | 532.91 kB | Adobe PDF | View/Open |
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