研究组织者： Sponsor: Capital Medical University Collaborator: Chinese Academy of Medical Sciences Information provided by (Responsible Party): Bin Cao, China-Japan Friendship Hospital
入选条件：
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Criteria Inclusion Criteria: [list=1] Age ≥18 years at time of signing Informed Consent Form Laboratory (RT-PCR) confirmed infection with 2019-nCoV. Lung involvement confirmed with chest imaging Hospitalised with: Fever - ≥36.7℃ -axilla or Oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal or And at least one of Respiratory rate >24/min Or Cough
≤8 days since illness onset Willingness of study participant to accept randomization to any assigned treatment arm. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
Exclusion Criteria: [list=1] Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit) SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg Known allergic reaction to remdesivir Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Pregnant or breastfeeding, or positive pregnancy test in a predose examination Will be transferred to another hospital which is not the study site within 72 hours. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation. 再问你：你有什么证据说入选条件是fda订的？
要求30天内没有使用其他药物治疗，这一点就掐死大多数病人了。 purplebasil 发表于 2/18/2020 11:43:59 AM
Exclusion Criteria: [list=1] Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit) Pregnant or breastfeeding, or positive pregnancy test in a predose examination Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Will be transferred to another hospital which is not the study site within 72 hours. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit) SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg Known allergic reaction to remdesivir Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Pregnant or breastfeeding, or positive pregnancy test in a predose examination Will be transferred to another hospital which is not the study site within 72 hours. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
I think taking tylenol or ibuprofen should not be an issue, fever-reducing is not experimental treatment
Exclusion Criteria: [list=1] Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit) Pregnant or breastfeeding, or positive pregnancy test in a predose examination Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Will be transferred to another hospital which is not the study site within 72 hours. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
Zhao Jianping, a doctor at Wuhan Tongji Hospital who is heading a team advising on the treatment of coronavirus patients, said in a Feb. 7 press conference that two-thirds of the severe patients in the trials would be given the drug while the other third would be given a placebo. Those in the placebo group would also receive the standard treatment, Dr. Zhao said.
Zhao Jianping, a doctor at Wuhan Tongji Hospital who is heading a team advising on the treatment of coronavirus patients, said in a Feb. 7 press conference that two-thirds of the severe patients in the trials would be given the drug while the other third would be given a placebo. Those in the placebo group would also receive the standard treatment, Dr. Zhao said.
🔥 最新回帖
如果吃的不是处方药，自己在家吃过啥药谁能知道？西药OTC也不可能挨家挨户差啊。这些药也没可能尿检血检出来。
说的好像美国人不会自己吃药一样，那么多otc都白瞎了吗？
那你是低级红？？
🛋️ 沙发板凳
要求30天内没有使用其他药物治疗 (treatment)，这一点就掐死大多数病人了。
... it is not practical...
是，critiera不能调整吗
这个在中国几乎不可能吧。国人生病习惯自己吃点抗生素， 中药
入选条件是fda订的，fda不想给人民用。
Fda 不写protocol 的。只能说公司太教条。
应该是没用过氯喹，克力芝就可以。
看了这种评论就知道我的国的在医学上就是一锅粥，发展的新药测试时估计也是跟着感觉走
不是这个意思啊。重症病人必须在发病时间12天以内，轻症病人必须在发病8天以内，文章写的很清楚。
30天是过去30天没有吃药(treatment)，这是为了保证用药的安全性和对药物疗效的合理判断，很多药在体内时间比较长，可能会跟新药有作用，可能是好的作用，也可能是不好的作用。
文章里提到主要的制约条件除了这个30天以外，还有就是核酸阳性，很多病人CT看起来是这个病，但是核酸是阴性。也不符合条件。
是的，按理新诊断的病人符合这个条件不难。可是中国国情，之前多少吃过双黄连抗生素之类，抗不住了才去医院检查的吧。
你是认真的吗？
感觉日本游轮上符合要求的病例可能会多一些。
对照组是用placedo和常规治疗方案，并不是不给医治。另外，治疗和对照组比例是2:1，所以，病人有2/3的概率上新药，1/3的概率用常规治疗。
美国才几个病例，远远不够
你有证据吗？没有自己删掉吧。
这个临床试验的Protocol 是研究人员自己制定的，这里可以看到：https://clinicaltrials.gov/ct2/show/NCT04252664
研究组织者：
Sponsor:
Capital Medical University
Collaborator:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Bin Cao, China-Japan Friendship Hospital
入选条件：
Inclusion Criteria: [list=1]
Age ≥18 years at time of signing Informed Consent Form
Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
Lung involvement confirmed with chest imaging
Hospitalised with:
Fever - ≥36.7℃ -axilla or Oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal or
And at least one of Respiratory rate >24/min Or Cough
≤8 days since illness onset
Willingness of study participant to accept randomization to any assigned treatment arm.
Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
Exclusion Criteria: [list=1]
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg
Known allergic reaction to remdesivir
Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Pregnant or breastfeeding, or positive pregnancy test in a predose examination
Will be transferred to another hospital which is not the study site within 72 hours.
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
再问你：你有什么证据说入选条件是fda订的？
是啊，这真的不能怪中国。很多人出现了症状之后服个退烧药很正常啊。
Exclusion Criteria: [list=1]
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
Pregnant or breastfeeding, or positive pregnancy test in a predose examination
Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Will be transferred to another hospital which is not the study site within 72 hours.
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
说的是30天内没有用过新冠肺炎的实验疗法，我的理解是因为同时还有几种其他的药在做实验，应该是那几种没有用过就可以。
退烧药抗生素什么的应该可以的。这个似乎不是那么难啊。感觉主要还是卡在确诊标准那里了，要核酸阳性，还要CT阳性
你得换个角度想。如果实验结果是新药无效，那这2/3的人不是被坑了？真没人愿意去冒这个险
Exclusion Criteria: [list=1]
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg
Known allergic reaction to remdesivir
Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Pregnant or breastfeeding, or positive pregnancy test in a predose examination
Will be transferred to another hospital which is not the study site within 72 hours.
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
I think taking tylenol or ibuprofen should not be an issue, fever-reducing is not experimental treatment
这种情况下，如果有早期证据证明新药无效，会立即停用。如果证明有效，对照组也会加入新药。
再说新药组的也不是只吃新药，支持性治疗都还是要上的
所以退烧药没事。然后吃过中药的都不行了。
难道急急忙忙的铺天盖地推中药就是为了这个目的？
中药不是大家一定要吃么？
这个30天不光是从加入trial之前30天不能用过别的药，而且加入后的28天也不可以。就是要是病人用的placebo，没有疗效，而病情恶化也只能干等着，不能上其他药。
不可能，病情恶化当然可以escape到open label 治疗组,这不是 临床试验常规操作吗。
你自己删了吧，解释的根本不对！说的是在开始服药后28天，不能加入新的临床试验研究。不退出RDV试验，吃别的，难道算placebo有效么？不都干扰了么！如果恶化，有几种退出临床试验的方法和根据。临床试验不是你想的那样。
clinical trial 就是这样子啊，每年做clinical trials的药也就10%左右能被approve，
所以四万病人招不了两百个。
需要病人在诊断第一时间就要求进组，并且坚决拒绝中药。
不是这样的，双盲保证的是去除主观的偏见，随机分组能尽量使两个组的病人特征平衡，但是如果进组的病人本身有吃了别的药的话，就算randomiza和双盲都没有用，因为无法证明最后的效果是你吃了别的药的结果还是在这个trial的用药效果。
这就是为什么要有招人的标准，而不是说谁都能参加试验。
我也听人说了，当时告诉我说是不能吃中药。结果好多人都灌过药汤。
这是你的理解，安慰剂组不会是别的治疗组，不然会明说别的药的治疗组
from the WSJ article:
Zhao Jianping, a doctor at Wuhan Tongji Hospital who is heading a team advising on the treatment of coronavirus patients, said in a Feb. 7 press conference that two-thirds of the severe patients in the trials would be given the drug while the other third would be given a placebo. Those in the placebo group would also receive the standard treatment, Dr. Zhao said.
您来说说最后这句话该如何理解？
安慰剂是指长得像瑞德西韦一样的点滴，这之外的治疗是常规标准治疗。退烧，抗生素，氧气都一样就是不能用抗病毒的药.
我现在觉得他找不到病人是不是因为中国人不理解什么是安慰剂啊。
新冠哪有standard treatment， 他是指的支持疗法吧
有啊，治疗指南都出第五版了！管用不管用是一回事，治疗标准当然是有的。我有好几个同学在武汉当医生，他们都是按指南写的来治疗，就是标准程序。
。。。这个真可以有 而且还有各国各种族。。。连他们前几天吃的是啥喝的是啥都有记录。。。
对照组其实就是跟其他不参加实验的人用一样的治疗方案，并没有少任何东西，只是多吃一份安慰剂。。。
对啊，安慰剂组没有抗病毒治疗，对随机双盲分到placebo组的病人，不是最符合病人利益的选择，IRB就不该批准的。最好设一个另外一种抗病毒药治疗组
如果是我也一定拒绝临床试验。万一瑞德西韦效果不好，那就相当于在治疗的黄金期没有使用抗病毒药物。这次肺炎特点就是迅速恶化，等恶化了再停止试验，那已经晚了。没有人愿意拿生命开玩笑。
这帖子里的很多讨论，无意识中已经认定瑞德西韦是有效的
不是没有使用其他药物，是没有使用其他试验药物。不过我估计off label use exclude了一堆人
不对，对照组不是单placebo，是标准疗法。常规治疗都上的
我又看了一遍，这个你说的对，是指30天内没有使用其他的 treatment
标准程序，除非病人在别的药品的实验组，不然都是一样的治疗方案，安慰剂组也是用这个标准程序
安慰剂组并不是不用任何抗病毒药物，而是不使用瑞德西韦。
举个例子，比方说现在武汉的病人标准程序就是上呼吸机，吃达菲，
那么在这个临川实验里，安慰剂组就是上呼吸机，吃达菲，注射生理盐水；实验组就是上呼吸机，吃达菲，注射瑞德西韦。
实验组也不是说光吃瑞德西韦不给用别的治疗。
不懂就问，什么是off label use?
就是不按处方说明的用药。比方说甘蔗的处方功能是治头疼的，你咳嗽了自己拿两根甘蔗吃了，这个就是off label use。
这个确实在中国还是挺普遍的，很多药不用处方都能随便买来吃，更别提各种中药了。
就是一个药本来是approve来治一个病的，或者只被approve在某个年龄层的，但是被医生用来治了另外一个病，或者用在了其他年龄层（比如成人药给了儿童）
比如克力芝只是被approve来治艾滋病，但是被医生拿来治了新冠，就是off label use （label上没有说治新冠）
一般来说这个概念是针对处方药
就算理解又怎样。招募的是轻中症的病人，人家根本没必要参加这个实验也应该基本能治好，试了还说不好有啥副作用，重症的想试也没机会。
inclusion exclusion criteria里面没有提轻症重症，只是说要核酸和CT都阳性，发烧超过38度，没有严重的肾病，没有使用过其他的实验性疗法
反华失心疯了吧，这也要怪土共。这是科学研究，有具体的程序和伦理要遵循。你做了个菜不好吃要不要怪土工啊？
我觉得也是。 正常治疗的死亡率算他2%, 轻症去试验，如果不配合其他正常的治疗，只是 placebo的话, 轻症的谁愿意去碰运气，变成重症的可能性可能一下提高了？
秀智商下限了吧？
"对照组是用placedo和常规治疗方案"——请问有证据吗？
对比实验里的对照病人不是什么都不给，是给市场已知的treatment，然后对比。只有比已知treatment好的，才能批准。
这是最基本药物审核标准
“安慰剂是指长得像瑞德西韦一样的点滴，这之外的治疗是常规标准治疗。”——请问你有证据吗？
这么激动是为哪般
谢谢mm
你是在说没有证据，是你自己这样认为的。
这是临床试验很典型的设计，尤其是重症病人，只用placebo很快就会挂的，IRB不会批的
"Remdesivir placebo"具体是什么成分？有证据吗？
你去看看药物clinical trial的几个phase是干啥呢，知道一些基本常识就不会这样瞎判断了
https://clinicaltrials.gov/ct2/show/NCT04257656
临床三期。control group的设计和临床三期的具体关系，麻烦您说一下。
这是常识，所有临床实验的对照组都是现有的常规疗法。
Remdesivir placebo 就是长得像RDV的placebo。
但这两个trial而言，CTgov上面的信息是不准确的。对照组应该是SOC 而非placebo。
CTgov上信息不准确也不少见，因为提交给CTgov的信息一般是sponsor compliance部门的人员，这些人背景各种各样，很多人并没有科学背景。如果review的人不仔细，信息很容易不准确。对于这两个光速开展的试验，review不准确很正常。
我想确认一下，试验组会继续使用常规的抗病毒药物加上瑞德西韦吗？还是只用瑞德西韦？
标准疗法（SOC）加瑞德西韦
如果是正常Design, 抗艾滋药和氯喹肯定不可以用。不然就是active.control 了。具体这个实验我不清楚。