当前位置: X-MOL 学术JAMA › 论文详情
Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics
JAMA ( IF 51.273 ) Pub Date : 2020-03-24 , DOI: 10.1001/jama.2020.4742
Andre C. Kalil

In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease (EVD), and numerous therapies were tested against this virus, including chloroquine, hydroxychloroquine, favipiravir, brincidofovir, monoclonal antibodies, antisense RNA, and convalescent plasma, among many others. With such a large number of therapeutic interventions given to affected patients, the goal was to determine which was efficacious against Ebola. Ultimately, none proved to be efficacious or safe. Why were new therapies not discovered? One reason is because virtually all studies were single-group interventions without concurrent controls, which led to no definitive conclusion related to efficacy or safety. Despite much resistance and controversy regarding asking patients with EVD to participate in a randomized clinical trial (RCT),1 the National Institutes of Health (NIH) conducted the first and only RCT during that outbreak. It took several months to design the trial, but it was implemented and successfully launched during the outbreak; however, it was too late for the RCT to be completed.2 This tragedy of not discovering new therapies during an outbreak cannot be repeated. The world is now facing a pandemic of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the cause of COVID-19), for which no proven specific therapies are available, other than supportive care. In China, and now Italy, France, and Spain, a large number of patients have received off-label and compassionate use therapies such as chloroquine, hydroxychloroquine, azithromycin, lopinavir-ritonavir, favipiravir, remdesivir, ribavirin, interferon, convalescent plasma, steroids, and anti–IL-6 inhibitors, based on either their in vitro antiviral or anti-inflammatory properties. These therapies have been mostly given without controls, except for a few randomized trials started in China, and more recently in the US.3
更新日期:2020-03-26

 

全部期刊列表>>
宅家赢大奖
向世界展示您的会议墙报和演示文稿
全球疫情及响应:BMC Medicine专题征稿
新版X-MOL期刊搜索和高级搜索功能介绍
化学材料学全球高引用
ACS材料视界
x-mol收录
自然科研论文编辑服务
南方科技大学
南方科技大学
西湖大学
中国科学院长春应化所于聪-4-8
复旦大学
课题组网站
X-MOL
深圳大学二维材料实验室张晗
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug