Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House that the results “don’t seem like a knockout,” though he noted that “it is a very important proof of concept.”
Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House that the results “don’t seem like a knockout,” though he noted that “it is a very important proof of concept.”
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.” 怎么能理解成 FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.” 怎么能理解成 FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
violabb 发表于 4/29/2020 12:35:14 PM
他这种级别的不都是being told ? 你还真期待他跳下来自己分析数据??? 揣着明白装糊涂吗? 再者 文章第一段 White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news.” contrast that with his statement on hydroxycholoroquinine
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.” 怎么能理解成 FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
The main concern, they say, stems from the fact that the Gilead trial expected to read out this week, which was conducted among patients with severe disease, lacks a control group — that is, patients who are randomly assigned to receive the best treatment available, but not remdesivir. As designed, the only randomization is the duration of treatment: either five days or 10 days of drug. Without a true control group of patients, many experts say, it will be difficult to determine whether remdesivir is effective.
“The overall study itself has little or no scientific value since all patients are receiving the drug,” said Steven Nissen, the chief academic officer at the Cleveland Clinic and lead investigator of many trials for heart drugs that have been approved by the Food and Drug Administration.
“The study, as designed, is essentially useless and cannot be used by the FDA for consideration of remdesivir for approval to treat coronavirus,” Nissen said.
Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called the situation “frustrating.”
“For them to run the trial in severe but not include a control group, it’s just such a waste,” Bach said. cannie 发表于 4/29/2020 9:34:27 AM
As we've been saying for some time now, accumulating data on Remdesivir suggests it's active against covid and there's now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line.
Gilead’s remdesivir, along with therapeutic antibodies and improved testing, is part of “a robust toolbox,” Dr. Scott Gottlieb says. “All of this is going to put us in a much different posture for the fall.” https://cnb.cx/2SgbRfu
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.” 怎么能理解成 FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.” 怎么能理解成 FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
Two groups were randomly selected. All patients were already sick enough to be hospitalized, but none of them was enough to be put on ventilators before the trial started
Yup. he also added that it will be part of the standard of care. This will change lots of things going forward. HCQ trial by MN will come out in 10 days or so too. Fingers crossed.
NIAID press release confirms Fauci comments in WH press pool: Median time to recovery (reached statistical significance): - 11 days for remdesivir group - 15 days for placebo group Mortality rate (not stat. sig.): - 8% for remdesivir - 11% for placebo
Dr. Fauci says the randomized, placebo-controlled study enrolled ~1,090 patients. The primary endpoint was the time to recovery and the ability to be discharged from the hospital. The independent Data Monitoring Committee informed him that remdesivir's clinical benefit was "clear-cut" and highly statistically significant (p<0.001). The drug's mortality benefit, while numerically better, is not yet statistically significant. Remdesivir represents a new standard-of-care for COVID-19. Studies testing remdesivir combined with other meds are next up.
1. Fauci statements below. and CNBC video here: https://twitter.com/nbcnews/status/1255541788154224641?s=21 - NYT: FDA to announce Emergency Use of remdesivir as early as Wednesday 2. 北京这次怎么这么恶心啊。刚出了好消息，然后就把在中国的“failed" study 结果贴在了lancet上。你们这些人，做事要有点良心。一次次刷底线，要脸么？ 3. 这个帖子一下子看出来需要屏蔽的id是什么。
两个Gilead自己的发布：
1. 第一个。这个是美国政府的双盲。
Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.
Gilead will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.
2.randomized trial Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
-- Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir --
Business Wire
FOSTER CITY, Calif. -- April 29, 2020
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.
In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.
Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.
Impact of Earlier Treatment
In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.
Key efficacy and safety results from the study are included in the table below.
5-Day RDV 10-Day RDV Baseline adjusted n=200 n=197 p-value^1 Clinical Efficacy Outcomes at Day 14 ≥ 2-point improvement in ordinal scale 129 (65) 107 (54) 0.16 Clinical recovery 129 (65) 106 (54) 0.17 Discharge 120 (60) 103 (52) 0.44 Death 16 (8) 21 (11) 0.70 Safety Any adverse event (AE) 141 (71) 145 (74) 0.86 Grade ≥3 study drug-related AE 8 (4) 10 (5) 0.65 Study drug-related serious adverse 3 (2) 4 (2) 0.73 event (SAE) AE leading to discontinuation 9 (5) 20 (10) 0.07
^1Adjusted for baseline clinical status
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19 infection.
The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, administered intravenously, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom.
A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.
NIAID press release confirms Fauci comments in WH press pool: Median time to recovery (reached statistical significance): - 11 days for remdesivir group - 15 days for placebo group Mortality rate (not stat. sig.): - 8% for remdesivir - 11% for placebo Jordan 发表于 2020-04-29 14:36
link please
Dr. Anthony Fauci, the NIAID’s director, told reporters at the White House that the results “don’t seem like a knockout,” though he noted that “it is a very important proof of concept.”
中国提交的报告，是大大的“NEGATIVE”，结论是，不建议对此药进行其他的实验
Cnbc 就有啊
https://www.cnbc.com/2020/04/29/dr-anthony-fauci-says-data-from-remdesivir-coronavirus-drug-trial-shows-quite-good-news.html
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.”
怎么能理解成
FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
宁死都不吃 用生命捍卫中药
他这种级别的不都是being told ? 你还真期待他跳下来自己分析数据??? 揣着明白装糊涂吗?
再者 文章第一段 White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news.” contrast that with his statement on hydroxycholoroquinine
那个比较慢还没出来，他家已上市的il6抑制剂，kevzara的结果出来了，对不插管的患者无效所以二期终止，现在就剩高剂量对插管患者的三期还在继续
说得有道理，福西自己没吃过这药就都是扯谎
说这话之前有点脑子，要有用，吃5天就够了不需要吃10天，懂么？收入都不足5000人民币的人，哪来那么大自信
I’m so happy!!!
反人类心态
。。。。。。 这个trial的目的就是看看能不能五天用药而不是十天阿，需要实证，不是你拍拍脑袋就说少吃肯定比多吃好的 但是吧，五天跟十天完全没有统计意义上的区别，就有好坏很多种解释了
嗯，对SARS也有效果。本质就是就是阻断以RNA作为遗传物质的病毒的自我繁殖，对RNA病毒都有效果，并非是来治愈人体组织，或者杀死活着的病毒。但是能够阻断病毒的自我繁殖，已经对人体很有意义了。可以做一个比喻，人体免疫系统和病毒两军交战，“人民的希望”是来断病毒大军的粮草的。
不光是冠状病毒，任何病毒都不容易克服。人类迄今为止，只有战胜过“天花”病毒，也是因为天花碰巧有个猪队友叫做牛痘。种牛痘也只是让人体免疫系统能够识别天花而已，并非能杀死人体内的天花病毒。严格意义来说，人类抗击病毒唯一的武器只有自身的免疫系统。疫苗和药物都只是辅助作用而已。但是不要小瞧这点辅助作用。
以小人之心，度君子之腹，原来这句成语就是为你这样的人定制的。
有对照组的结果还没出来。但是全世界感染病毒的两百多万，重症死亡率一目了然。华尔街不是傻子。
作为前FDA的负责人, 他肯定知道外界没有的信息, 他这样确信, 应该没问题了。前几天, 连Jeb Bush 都顶Dr. Gottlieb的推特了, 楼里的五毛外宣, 该散了。脱钩进行的怎么样了, 美华也非常支持脱钩啊, 北朝鲜挺适合你们, 而且人家不祸害世界, 你们努力啊, 加油!
觉得中国确实该讨打讨骂。人家为了抗疫，药方都公布了，让你随便用。结果为了自己那点屁利益，连个反馈都不给，好不好使的让人家主人知道一下不行吗？太自私！
大陆这次整个灾害中一再自我侮辱，世界上还有哪个国家更辱华？大陆帮帮忙，不要一再使我们在中国之外的华人脸上无光。
内行人一看就知道结论是人造的。生物统计的test 设计是很严格的。哪能这样乱来。
这波炒作，就是华尔街想割韭菜。不信的就进场接盘。
唯有脱钩一条路可走, 所以我们应该给楼里的几毛外宣加加油, 助脱钩成功!
我昨天在一个群里看见国内有人说，江浙沪其实用了不少此药
赶紧批准吧，这药再没用的话真的是都要绝望了
呵呵，呵呵，呵呵呵呵呵。
是啊，希望最后是有用的结论。
我记得看到报道带去意大利的仿药，盒子上标的就是浙江某厂生产的，如果国内用了，我不会惊讶
花街这波炒作真是无耻啊。偷梁换柱，混淆视听，指鹿为马。
不significant ，这些结果有鬼用啊？？
Fauci said he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.”
怎么能理解成
FAUCI: DATA SHOWS REMDESIVIR `CLEAR CUT' POSITIVE EFFECT
你第一句话不对。
一个药若能将病程缩短哪怕25%的时间，对医院对经济对社会的正面影响都会是巨大的。ask any economist, doctor, public health guy。因为我们现在讨论的不是单一的个体，而是指数成长的pandemic
你们几个翻来覆去的互相顶有意思吗？前几贴不是贴了对照组结果了吗？你是不认识汉字还是读不懂英文呢还是有别的目的呢？ 这肯定不是特效药，但比那个双黄连强到哪里去了。我就好奇没有人去测测双黄连和莲花清瘟里有没有人民的希望的成分。你们洗得这么弱智那还是不要洗了。
啥表演？
我希望看到两组都是15天的结果. 你要知道第一个组吃了药之后11天并不是都好了,11天之后死的就不计在内了
不太明白你的意思。上面有人引用time to recover is 11 days， recover的含义应该包括继续活下去吧
No. 用人民希望五天，两周后出院率只有63%。 还比不上用氯喹的。
因为他们根本不看英文的原版报道和视频，wm看到这个结果要疯了。
NIAID这个一千多病人的临床实验是双盲，效果显著，P value是0.001, statistically highly significant
Dr Fauci讲得很清楚，听听这个https://twitter.com/nbcnews/status/1255541788154224641?s=21
Two groups were randomly selected. All patients were already sick enough to be hospitalized, but none of them was enough to be put on ventilators before the trial started
对，我也刚看了这个视频，讲的很清楚了。这个帖子里能看出多少人颠倒黑白。
Yup. he also added that it will be part of the standard of care. This will change lots of things going forward.
HCQ trial by MN will come out in 10 days or so too. Fingers crossed.
haha [tuzki33]
我一直追的就是这个临床，2月就在https://clinicaltrials.gov/上显示了
别说毛们还挺敬业的，深夜坚持上班。不过也有可能是什么使领馆、国企之类的驻美人员和家属，就不用深夜加班这么辛苦了。
理它都是多余，屏蔽掉它就好了
去听了一下这个，非常positive啊，楼里一堆人在带什么节奏？难道他们比Dr. Fauci还专业？
制造恐慌带节奏，能坑美国一点是一点，已经彻底不要脸了
这药的实验结果，基本上跟 吃维生素C 的效果一样啊。 。
美国还在大辩论的时候，那边早就进入战时操作了，那边的想法就是对敌人要无所不用其极的攻击
吃维生素C 有对照组吗？能降低吗？
能降低好事呀，和瑞德西韦又不冲突，一起吃起来
他们这样做实在太坏了，别有用心的坏！损人不利己、见不得别人好的劣根性一览无余。现在证实此药有效，真的太令人开心了，希望有越来越多好消息！
你丫扯淡。
顶LZ一下。
由此可以看到WHO有多恶心。
呵呵，看来是金融小白。华尔街如果要割韭菜，就应该卖。华尔街自己砸钱进来，是送韭菜还是割韭菜啊。美股和A股不一样。你以为美股是散户的天下？美股散户全部资金打入市场，也掀不起一滴浪花。美股大盘上下涨幅，基本都是机构一起做起来的（而且不止单个机构）。你顶多可以说机构割机构。华尔街没人有兴趣去割韭菜。韭菜那点钱，还不够一个小机构塞牙缝。。。
偷偷用了别人给的药方其实有用，然后还非要告诉别人你们这药没用千万别用，怎么能这么坏！
太好了！
我知道的有3个垂危病人用药后转危为安的例子：
1. 美国第一个病人西雅图相亲小哥
2. 新泽西第一个病人James Cai
3. 纽约医生Arnold Weg，用药前他家已经开始为他准备后事。
这些病人虽然还没有插管但如果不用这个药面临的是死亡或插管后死亡，人民的希望救了他们的命，请你告诉我他们如果用VC会不会活下来？
另外前几天报道纽约插管病人接近90%死亡，但下面这篇科学论文给出的有限的病例显示用药后只有18%的插管病人死亡，请你告诉我这些用药后活下来的插管病人如果用VC会不会活下来？
意思应该就是 remdesivir 不能在中国卖了。至于会不会进一步操作把仿药换个包装当作神药单独或跟其他中国特色药组合卖，就不清楚了
这个结果非常好啊，这么好的效果，按理中国做三百人也应该比中国公布的效果更好，不理解。
它们的目的就是保证版面上一眼看过去，有能让美国混乱的信息就可以了，它们所有的帖子标题一定鲜明的点出美国玩完
https://www.nytimes.com/2020/04/29/us/coronavirus-usa-cases-deaths.html?action=click&module=RelatedLinks&pgtype=Article