这是刊登在著名《新英格兰医学杂志》的非双盲remdesivir 三期临床试验，说明有随机开放的三期试验，不能由此判断是编造的

来源: 于 2021-02-05 17:14:26 [博客] [旧帖] [给我悄悄话] 本文已被阅读：次

https://www.nejm.org/doi/full/10.1056/NEJMoa2015301

方法

我们进行了一项随机，开放标签的3期临床试验，涉及住院患者的确诊SARS-CoV-2感染，呼吸环境空气时氧饱和度不超过94％以及肺炎的放射学证据。患者按1：1比例随机分配，接受5天或10天静脉注射雷姆昔韦。所有患者均在第1天接受200 mg瑞地昔韦，随后几天每天接受100 mg一次。主要终点为第14天的临床状态，按7点顺序量表进行评估。

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

List of authors.

  • Jason D. Goldman, M.D., M.P.H., 
  • David C.B. Lye, M.B., B.S., 
  • David S. Hui, M.D., 
  • Kristen M. Marks, M.D., 
  • Raffaele Bruno, M.D., 
  • Rocio Montejano, M.D.,

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. opens in new tab.)