Gilead官宣，初步结果有效。 The treatment resulted in clinical improvement for 68% of the patients after a median follow-up of 18 days from the first dose, and no new safety signals were identified.
After 28 days of follow-up, 84% showed clinical improvement, defined as discharge from the hospital and/or a specific improvement on a predefined six-point scale. Seven of the 53 patients died.
Gilead's remdesivir shows positive effect in COVID-19 patients Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor A cohort analysis of 53 severely ill hospitalized COVID-19 patients who received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a compassionate use basis showed a treatment benefit. The data were just published in the New England Journal of Medicine.
64% (n=34/53) of patients were on mechanical ventilation at baseline, including four also on extracorporeal membrane oxygenation (blood is circulated through an artificial lung to oxygenate).
68% of patients receiving remdesivir experienced an improvement in oxygen support class over median follow-up of 18 days. 57% (n=17/30) of those on mechanical ventilation were extubated and 47% (25/53) of the total group were discharged from the hospital.
After 28 days of follow-up, the cumulative incidence of clinical improvement was 84% (discharge from hospital and/or at least a two-point improvement from baseline in predefined six-point scale).
The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a subgroup of patients on invasive ventilation.
No new safety signals were observed.
Two Phase 3 studies are in process with topline data from one, SIMPLE, expected this month.
A China-based study in severely ill COVID-19 patients has been terminated due to low enrollment while another in mild-to-moderately ill patients in ongoing.
More than 1,800 patients have received remdesivir to date.
18%降到了13% 【 在 nvs (drug) 的大作中提到: 】 : 标 题: Re: 瑞德西韦临床的结果不容乐观 : 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东) : : Gilead's remdesivir shows positive effect in COVID-19 patients : Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. : House, SA News Editor : A cohort analysis of 53 severely ill hospitalized COVID-19 patients who : received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a : compassionate use basis showed a treatment benefit. The data were just : published in the New England Journal of Medicine. : : 64% (n=34/53) of patients were on mechanical ventilation at baseline, : including four also on extracorporeal membrane oxygenation (blood is : circulated through an artificial lung to oxygenate). : : 68% of patients receiving remdesivir experienced an improvement in oxygen : support class over median follow-up of 18 days. 57% (n=17/30) of those on : mechanical ventilation were extubated and 47% (25/53) of the total group : were discharged from the hospital. : : After 28 days of follow-up, the cumulative incidence of clinical improvement : was 84% (discharge from hospital and/or at least a two-point improvement : from baseline in predefined six-point scale). : : The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a : subgroup of patients on invasive ventilation. : : No new safety signals were observed. : : Two Phase 3 studies are in process with topline data from one, SIMPLE, : expected this month. : : A China-based study in severely ill COVID-19 patients has been terminated : due to low enrollment while another in mild-to-moderately ill patients in : ongoing. : : More than 1,800 patients have received remdesivir to date. : --
More than half the patients in the study experienced side effect from the drug, ranging from a rash and diarrhea to acute kidney injury. 【 在 yuwenchengdu (吊丝) 的大作中提到: 】 : 标 题: Re: 瑞德西韦临床的结果不容乐观 : 发信站: BBS 未名空间站 (Fri Apr 10 19:56:42 2020, 美东) : : 似乎还是有效的啊 : : 18%降到了13% : 【 在 nvs (drug) 的大作中提到: 】 : : 标 题: Re: 瑞德西韦临床的结果不容乐观 : : 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东) : : : : Gilead's remdesivir shows positive effect in COVID-19 patients : : Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W : . : : House, SA News Editor : : A cohort analysis of 53 severely ill hospitalized COVID-19 patients who : : received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a : : compassionate use basis showed a treatment benefit. The data were just : : published in the New England Journal of Medicine. : : : : 64% (n=34/53) of patients were on mechanical ventilation at baseline, : : including four also on extracorporeal membrane oxygenation (blood is : : circulated through an artificial lung to oxygenate). : : : : 68% of patients receiving remdesivir experienced an improvement in oxygen : : support class over median follow-up of 18 days. 57% (n=17/30) of those on : : mechanical ventilation were extubated and 47% (25/53) of the total group : : were discharged from the hospital. : : : : After 28 days of follow-up, the cumulative incidence of clinical : improvement : : was 84% (discharge from hospital and/or at least a two-point improvement : : from baseline in predefined six-point scale). : : : : The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a : : subgroup of patients on invasive ventilation. : : : : No new safety signals were observed. : : : : Two Phase 3 studies are in process with topline data from one, SIMPLE, : : expected this month. : : : : A China-based study in severely ill COVID-19 patients has been terminated : : due to low enrollment while another in mild-to-moderately ill patients in : : ongoing. : : : : More than 1,800 patients have received remdesivir to date. : : --
【 在 yuwenchengdu (吊丝) 的大作中提到: 】 : 标 题: Re: 瑞德西韦临床的结果不容乐观 : 发信站: BBS 未名空间站 (Fri Apr 10 19:56:42 2020, 美东) : : 似乎还是有效的啊 : : 18%降到了13% : 【 在 nvs (drug) 的大作中提到: 】 : : 标 题: Re: 瑞德西韦临床的结果不容乐观 : : 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东) : : : : Gilead's remdesivir shows positive effect in COVID-19 patients : : Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W : . : : House, SA News Editor : : A cohort analysis of 53 severely ill hospitalized COVID-19 patients who : : received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a : : compassionate use basis showed a treatment benefit. The data were just : : published in the New England Journal of Medicine. : : : : 64% (n=34/53) of patients were on mechanical ventilation at baseline, : : including four also on extracorporeal membrane oxygenation (blood is : : circulated through an artificial lung to oxygenate). : : : : 68% of patients receiving remdesivir experienced an improvement in oxygen : : support class over median follow-up of 18 days. 57% (n=17/30) of those on : : mechanical ventilation were extubated and 47% (25/53) of the total group : : were discharged from the hospital. : : : : After 28 days of follow-up, the cumulative incidence of clinical : improvement : : was 84% (discharge from hospital and/or at least a two-point improvement : : from baseline in predefined six-point scale). : : : : The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a : : subgroup of patients on invasive ventilation. : : : : No new safety signals were observed. : : : : Two Phase 3 studies are in process with topline data from one, SIMPLE, : : expected this month. : : : : A China-based study in severely ill COVID-19 patients has been terminated : : due to low enrollment while another in mild-to-moderately ill patients in : : ongoing. : : : : More than 1,800 patients have received remdesivir to date. : : --
Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“...we have been informed that the study in patients with severe symptoms was stopped due to stalled enrollment".
不是副作用，是用药后出现的恶化，但是新冠重症本来就会出现这些恶化，所以无法判定是用药造成的。 【 在 yuwenchengdu (吊丝) 的大作中提到: 】 : 似乎提到了副作用 : More than half the patients in the study experienced side effect from the : drug, ranging from a rash and diarrhea to acute kidney injury. : W : oxygen : on : improvement : a : terminated : in
曹彬的实验设计也有问题，一是入组条件太僵化，比如之前一定不能用过其他药，其实这些可以通过设计克服。二是紧急情况特殊处理，很多人一听有安慰剂就不愿加入了，其实完全可以和克力芝，氯喹之类的盲比，事先配好每组一个针剂一个口服药的组合，要么针剂是安慰剂要么口服药是安慰剂，然后病人每天又打针又吃药，肯定愿意加入的一大堆。 【 在 libaliu () 的大作中提到: 】 : Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“ : ...we have : been informed that the study in patients with severe symptoms was stopped : due to stalled enrollment". : 太TM荒唐了，当时武汉乌泱乌泱的病人，危重症多的是，居然招不到病人。看来在关键 : 时刻不能指望厉害国。
【 在 libaliu () 的大作中提到: 】 : Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“ : ...we have : been informed that the study in patients with severe symptoms was stopped : due to stalled enrollment
1. Gilead在读取了中期结果后，大大增加了病人样本数量。学过统计的都知道这说明
按目前的样本大小做不出统计学意义。
2. 曹彬的实验同样在月初读取了数据，没有中止实验。说明瑞德西韦虽然无害，但目
前的数据也做不出统计意义。
3. 曹彬的实验定于4月27日公布结果，要是宣布无效，大盘恐怕会有一波暴跌。
gilead本来就不怎么波动......不是小药厂就只靠一两个药过日子的
【 在 Foxman (今狐冲) 的大作中提到: 】
: 1. Gilead在读取了中期结果后，大大增加了病人样本数量。学过统计的都知道这说明
: 按目前的样本大小做不出统计学意义。
: 2. 曹彬的实验同样在月初读取了数据，没有中止实验。说明瑞德西韦虽然无害，但目
: 前的数据也做不出统计意义。
: 3. 曹彬的实验定于4月27日公布结果，要是宣布无效，恐怕会有一波暴跌。
这个药有效与否对Gilead短期影响本来就不大，因为不可能靠他盈利
但我觉得对整个大盘可能会有很大的影响
【 在 investonly (我是朱坚强，不是范跑跑) 的大作中提到: 】
: gilead本来就不怎么波动......不是小药厂就只靠一两个药过日子的
没效果的话，不是应该中止实验？
怎么会增加人数？
没有meet overwhelming efficacy，但是也没有meet futility呗。
然后re-estimate sample size，继续试试看怎么样。
没细看，他们选的endpoint是啥？几天不发烧？
【 在 Noktard (万老) 的大作中提到: 】
: 没效果的话，不是应该中止实验？
: 怎么会增加人数？
跟大盘有什么关系？无非是他自家股票补跌个15%罢了。大盘从来就没有指望过有特效
药。
【 在 Foxman (今狐冲) 的大作中提到: 】
: 1. Gilead在读取了中期结果后，大大增加了病人样本数量。学过统计的都知道这说明
: 按目前的样本大小做不出统计学意义。
: 2. 曹彬的实验同样在月初读取了数据，没有中止实验。说明瑞德西韦虽然无害，但目
: 前的数据也做不出统计意义。
: 3. 曹彬的实验定于4月27日公布结果，要是宣布无效，大盘恐怕会有一波暴跌。
★ 发自iPhone App: ChinaWeb 1.1.5
增加病人数量是因为停止了同情用药的申请，而是让病人进入临床试验用药。
【在 Foxman(今狐冲)的大作中提到：】
：1. Gilead在读取了中期结果后，大大增加了病人样本数量。学过统计的都知道这说明
：按目前的样本大小做不出统计学意义。
Adaptive design?
【 在 robck (万廷) 的大作中提到: 】
: 增加病人数量是因为停止了同情用药的申请，而是让病人进入临床试验用药。
: ：1. Gilead在读取了中期结果后，大大增加了病人样本数量。学过统计的都知道这
说明
: ：按目前的样本大小做不出统计学意义。
大盘并不是看这个，影响不会太大
【 在 Foxman(今狐冲) 的大作中提到: 】
: 这个药有效与否对Gilead短期影响本来就不大，因为不可能靠他盈利
: 但我觉得对整个大盘可能会有很大的影响
吉利德科学：在有限的数据组中，瑞德西韦治疗能够改善68%的患者的临床症状。
估计是无效。中国区的数据应该出来了，只是没公布。中国都没有病人了，还能怎么做临床啊？只能是等其他国家地区的数据看还有没有希望。基本上是凉了。
Gilead官宣，初步结果有效。
The treatment resulted in clinical improvement for 68% of the patients after a median follow-up of 18 days from the first dose, and no new safety
signals were identified.
After 28 days of follow-up, 84% showed clinical improvement, defined as
discharge from the hospital and/or a specific improvement on a predefined
six-point scale. Seven of the 53 patients died.
Gilead's remdesivir shows positive effect in COVID-19 patients
Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
A cohort analysis of 53 severely ill hospitalized COVID-19 patients who
received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a
compassionate use basis showed a treatment benefit. The data were just
published in the New England Journal of Medicine.
64% (n=34/53) of patients were on mechanical ventilation at baseline,
including four also on extracorporeal membrane oxygenation (blood is
circulated through an artificial lung to oxygenate).
68% of patients receiving remdesivir experienced an improvement in oxygen
support class over median follow-up of 18 days. 57% (n=17/30) of those on
mechanical ventilation were extubated and 47% (25/53) of the total group
were discharged from the hospital.
After 28 days of follow-up, the cumulative incidence of clinical improvement was 84% (discharge from hospital and/or at least a two-point improvement
from baseline in predefined six-point scale).
The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a
subgroup of patients on invasive ventilation.
No new safety signals were observed.
Two Phase 3 studies are in process with topline data from one, SIMPLE,
expected this month.
A China-based study in severely ill COVID-19 patients has been terminated
due to low enrollment while another in mild-to-moderately ill patients in
ongoing.
More than 1,800 patients have received remdesivir to date.
依靠兲朝的数据做研究，那后面的东西谁敢信？
【 在 whitesand (whitesand) 的大作中提到: 】
: 标 题: Re: 瑞德西韦临床的结果不容乐观
: 发信站: BBS 未名空间站 (Fri Apr 10 15:44:21 2020, 美东)
:
: 估计是无效。中国区的数据应该出来了，只是没公布。中国都没有病人了，还能怎么做
: 临床啊？只能是等其他国家地区的数据看还有没有希望。基本上是凉了。
: --
美国有个大规模的三期，到5月中。国内那个组数据确实让人担心，国人吃吃中药一样
有效果。
【 在 ananpig (别瞅 变态辣椒 漫画的●○安安猪) 的大作中提到: 】
: 依靠兲朝的数据做研究，那后面的东西谁敢信？
周一GILD 可以回到85刀前其高点？
现在是初步结果，如果正式结果出来也不错的话FDA肯定会快速批准，那么股价100以上也不奇怪。
【 在 Gtrader(易交) 的大作中提到: 】
: 周一GILD 可以回到85刀前其高点？
似乎还是有效的啊
18%降到了13%
【 在 nvs (drug) 的大作中提到: 】
: 标 题: Re: 瑞德西韦临床的结果不容乐观
: 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东)
:
: Gilead's remdesivir shows positive effect in COVID-19 patients
: Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W.
: House, SA News Editor
: A cohort analysis of 53 severely ill hospitalized COVID-19 patients who
: received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a
: compassionate use basis showed a treatment benefit. The data were just
: published in the New England Journal of Medicine.
:
: 64% (n=34/53) of patients were on mechanical ventilation at baseline,
: including four also on extracorporeal membrane oxygenation (blood is
: circulated through an artificial lung to oxygenate).
:
: 68% of patients receiving remdesivir experienced an improvement in oxygen : support class over median follow-up of 18 days. 57% (n=17/30) of those on : mechanical ventilation were extubated and 47% (25/53) of the total group
: were discharged from the hospital.
:
: After 28 days of follow-up, the cumulative incidence of clinical
improvement
: was 84% (discharge from hospital and/or at least a two-point improvement : from baseline in predefined six-point scale).
:
: The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a : subgroup of patients on invasive ventilation.
:
: No new safety signals were observed.
:
: Two Phase 3 studies are in process with topline data from one, SIMPLE,
: expected this month.
:
: A China-based study in severely ill COVID-19 patients has been terminated : due to low enrollment while another in mild-to-moderately ill patients in : ongoing.
:
: More than 1,800 patients have received remdesivir to date.
: --
似乎提到了副作用
More than half the patients in the study experienced side effect from the
drug, ranging from a rash and diarrhea to acute kidney injury.
【 在 yuwenchengdu (吊丝) 的大作中提到: 】
: 标 题: Re: 瑞德西韦临床的结果不容乐观
: 发信站: BBS 未名空间站 (Fri Apr 10 19:56:42 2020, 美东)
:
: 似乎还是有效的啊
:
: 18%降到了13%
: 【 在 nvs (drug) 的大作中提到: 】
: : 标 题: Re: 瑞德西韦临床的结果不容乐观
: : 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东)
: :
: : Gilead's remdesivir shows positive effect in COVID-19 patients
: : Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W
: .
: : House, SA News Editor
: : A cohort analysis of 53 severely ill hospitalized COVID-19 patients who : : received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a
: : compassionate use basis showed a treatment benefit. The data were just
: : published in the New England Journal of Medicine.
: :
: : 64% (n=34/53) of patients were on mechanical ventilation at baseline,
: : including four also on extracorporeal membrane oxygenation (blood is
: : circulated through an artificial lung to oxygenate).
: :
: : 68% of patients receiving remdesivir experienced an improvement in
oxygen
: : support class over median follow-up of 18 days. 57% (n=17/30) of those
on
: : mechanical ventilation were extubated and 47% (25/53) of the total group
: : were discharged from the hospital.
: :
: : After 28 days of follow-up, the cumulative incidence of clinical
: improvement
: : was 84% (discharge from hospital and/or at least a two-point
improvement
: : from baseline in predefined six-point scale).
: :
: : The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a
: : subgroup of patients on invasive ventilation.
: :
: : No new safety signals were observed.
: :
: : Two Phase 3 studies are in process with topline data from one, SIMPLE,
: : expected this month.
: :
: : A China-based study in severely ill COVID-19 patients has been
terminated
: : due to low enrollment while another in mild-to-moderately ill patients
in
: : ongoing.
: :
: : More than 1,800 patients have received remdesivir to date.
: : --
死亡率百分之几的病试验几百个病人如果不严格匹配对照组恐怕很难看出差别，重症病人倒是可能容易看出差别。
初步感觉在这个范围还是不够有效
【 在 yuwenchengdu (吊丝) 的大作中提到: 】
: 标 题: Re: 瑞德西韦临床的结果不容乐观
: 发信站: BBS 未名空间站 (Fri Apr 10 19:56:42 2020, 美东)
:
: 似乎还是有效的啊
:
: 18%降到了13%
: 【 在 nvs (drug) 的大作中提到: 】
: : 标 题: Re: 瑞德西韦临床的结果不容乐观
: : 发信站: BBS 未名空间站 (Fri Apr 10 17:03:12 2020, 美东)
: :
: : Gilead's remdesivir shows positive effect in COVID-19 patients
: : Apr. 10, 2020 3:58 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W
: .
: : House, SA News Editor
: : A cohort analysis of 53 severely ill hospitalized COVID-19 patients who : : received Gilead Sciences' (NASDAQ:GILD) antiviral remdesivir on a
: : compassionate use basis showed a treatment benefit. The data were just
: : published in the New England Journal of Medicine.
: :
: : 64% (n=34/53) of patients were on mechanical ventilation at baseline,
: : including four also on extracorporeal membrane oxygenation (blood is
: : circulated through an artificial lung to oxygenate).
: :
: : 68% of patients receiving remdesivir experienced an improvement in
oxygen
: : support class over median follow-up of 18 days. 57% (n=17/30) of those
on
: : mechanical ventilation were extubated and 47% (25/53) of the total group
: : were discharged from the hospital.
: :
: : After 28 days of follow-up, the cumulative incidence of clinical
: improvement
: : was 84% (discharge from hospital and/or at least a two-point
improvement
: : from baseline in predefined six-point scale).
: :
: : The overall mortality rate was 13% (n=7/53), lower than 18% (n=6/34) in a
: : subgroup of patients on invasive ventilation.
: :
: : No new safety signals were observed.
: :
: : Two Phase 3 studies are in process with topline data from one, SIMPLE,
: : expected this month.
: :
: : A China-based study in severely ill COVID-19 patients has been
terminated
: : due to low enrollment while another in mild-to-moderately ill patients
in
: : ongoing.
: :
: : More than 1,800 patients have received remdesivir to date.
: : --
Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“...we have
been informed that the study in patients with severe symptoms was stopped
due to stalled enrollment".
太TM荒唐了，当时武汉乌泱乌泱的病人，危重症多的是，居然招不到病人。看来在关键时刻不能指望厉害国。
【 在 majiaabc (青蛙钓鱼啦) 的大作中提到: 】
: 美国有个大规模的三期，到5月中。国内那个组数据确实让人担心，国人吃吃中药一样
: 有效果。
不是副作用，是用药后出现的恶化，但是新冠重症本来就会出现这些恶化，所以无法判定是用药造成的。
【 在 yuwenchengdu (吊丝) 的大作中提到: 】
: 似乎提到了副作用
: More than half the patients in the study experienced side effect from the : drug, ranging from a rash and diarrhea to acute kidney injury.
: W
: oxygen
: on
: improvement
: a
: terminated
: in
曹彬的实验设计也有问题，一是入组条件太僵化，比如之前一定不能用过其他药，其实这些可以通过设计克服。二是紧急情况特殊处理，很多人一听有安慰剂就不愿加入了，其实完全可以和克力芝，氯喹之类的盲比，事先配好每组一个针剂一个口服药的组合，要么针剂是安慰剂要么口服药是安慰剂，然后病人每天又打针又吃药，肯定愿意加入的一大堆。
【 在 libaliu () 的大作中提到: 】
: Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“
: ...we have
: been informed that the study in patients with severe symptoms was stopped : due to stalled enrollment".
: 太TM荒唐了，当时武汉乌泱乌泱的病人，危重症多的是，居然招不到病人。看来在关键
: 时刻不能指望厉害国。
双盲，不愿意做安慰剂的那一组
【 在 libaliu () 的大作中提到: 】
: Gilead CEO发布的消息中提到，在中国的重症组实验已经由于招募不到病人而停止：“
: ...we have
: been informed that the study in patients with severe symptoms was stopped : due to stalled enrollment
★ 发自iPhone App: ChinaWeb 1.1.5