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Title: Remdesivir for 5 or 10 Days in Patients With Severe Covid-19
Author: Goldman, Jason D.
Lye, David C.B.
Hui, David S.
Marks, Kristen M.
Bruno, Raffaele
Montejano, Rocio
Spinner, Christoph D.
Galli, Massimo
Ahn, Mi‑Young
Nahass, Ronald G.
Chen, Yao-Shen
SenGupta, Devi
Hyland, Robert H.
Osinusi, Anu O.
Cao, Huyen
Blair, Christiana
Wei, Xuelian
Gaggar, Anuj
Brainard, Diana M.
Towner, William J.
Muñoz Gutiérrez, José
Mullane, Kathleen M.
Marty, Francisco M.
Tashima, Karen T.
Diaz, George
Subramanian, Aruna
GS-US-540-5773 Investigators
Keywords: COVID-19
Assaigs clínics
Clinical trials
Issue Date: 27-May-2020
Publisher: Massachusetts Medical Society
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 number, NCT04292899.).
Note: Reproducció del document publicat a:
It is part of: New England Journal of Medicine, 2020, vol. 383, p. 1827-1837
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ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (ISGlobal)

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