ZT Compassionate Use of Remdesivir for Patients with severe Covi

ORIGINAL ARTICLE

Compassionate Use of Remdesivir for Patients with Severe Covid-19

List of authors.

• Jonathan Grein, M.D., 
• Norio Ohmagari, M.D., Ph.D., 
• Daniel Shin, M.D., 
• George Diaz, M.D., 
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• et al.

April 10, 2020
DOI: 10.1056/NEJMoa2007016

• Article
• Figures/Media

Metrics

• 29 References

Abstract

BACKGROUND

Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.

METHODS

We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day.

RESULTS

Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

CONCLUSIONS

In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)

所有跟帖： 

• 这个资料最大的问题：1.不是双盲实验，没有对照。2.是生产厂家赞助的，包括多国的病人也不知他们是如何选择的病例。 -老道- ♂ (0 bytes) () 04/10/2020 postreply 17:08:44

• +, 特殊时期，双盲可省略。没有对照，硬伤。 -欲千北- ♂ (0 bytes) () 04/10/2020 postreply 19:28:46

• 这篇文章作为病例报道是没问题的，但无法以此证明这个药有效。 -老道- ♂ (0 bytes) () 04/10/2020 postreply 19:41:07

• 这药，美国临床试验5月份才结束，等看结果报告。 -pickshell- ♀ (0 bytes) () 04/10/2020 postreply 18:40:39