--------- 纠正一下我的原文，虽然是illness of any duration，但是需要具有出肺部浸润/血氧降低/需要吸氧三个指标之一才可以
Criteria Inclusion Criteria: [list=1]
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol. Male or non-pregnant female adult >/=18 years of age at time of enrollment. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization. Illness of any duration, and at least one of the following:
Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR Requiring mechanical ventilation and/or supplemental oxygen.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
回复 30楼ljmdtc的帖子 参与者和trial investigator 是blinded. 但是不是所有人。The DSMB will recommend the study be halted if there is clear and substantial evidence of a treatment difference between drug and placebo。
参与者和trial investigator 是blinded. 但是不是所有人。The DSMB will recommend the study be halted if there is clear and substantial evidence of a treatment difference between drug and placebo。
是的，纠正一下我的原文，虽然是illness of any duration，但是需要具有出肺部浸润/血氧降低/需要吸氧三个指标之一才可以 Criteria Inclusion Criteria: [list=1] Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol. Male or non-pregnant female adult >/=18 years of age at time of enrollment. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR Requiring mechanical ventilation and/or supplemental oxygen.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
2月21号注册的美国开展的针对新冠肺炎的临床试验，计划招募394例病人，第一例病人已经开始，是从公主号上面来的美国公民，初步定下来用药方案以后接下来会展开多州的试验，
https://clinicaltrials.gov/ct2/show/NCT04280705?term=remdesivir&draw=2&rank=3
这个临床试验是adaptive的，也就是对于多数确诊了的、住院的病人，轻重症都可以用药，这样一来从现在开始美国新确诊的新冠肺炎病人也许都有机会进入人民的希望的试药了（随机分到安慰剂组除外）
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另外，这个试验是属于phase2 （二期临床），旨在全球同时调查这个药对肺炎病人的安全性和效果，医生（care provider）和效果评价人（outcome assessor）是知道那组是实验组哪组是安慰剂组的，所以效果好不好非常快就能知道，不需要到了揭盲那一天
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纠正一下我的原文，虽然是illness of any duration，但是需要具有出肺部浸润/血氧降低/需要吸氧三个指标之一才可以
Criteria
Inclusion Criteria: [list=1]
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
Male or non-pregnant female adult >/=18 years of age at time of enrollment.
Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
Illness of any duration, and at least one of the following:
Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
Requiring mechanical ventilation and/or supplemental oxygen.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
我一开始也很激动，定睛一看是2023年4月1号。。。
不过只要人数够了应该就可以宣告临床试验结束
这个是global的试验，先在美国开始，后面可以有国际上的志愿者参与
呃... 是哦
那黄花菜都凉了
小看药厂效率了，何止protocol, 估计NDA filing的模版都写好了，等着填数据
不是说phase2 已经完成了吗？
期待。。。
中国的trial应该也有这一条吧，不然ethics怎么过的。
所以我挺悲观的，中国试验一直没叫停，应该是效果也不是特别神奇吧。如果个个都像美国第一例，200人也够统计显著差异了。
Protocol 里写的必须有呼吸困难需要吸氧或机械通气才能参与临床实验，类似于中国的重症。光发烧咳嗽不能用。
美国已经有两例，法国有一例，都治愈了。中国那边不知道现在是什么情况，没有消息，但仿制药的消息又不断。
法国死的那例用药了吗？
新闻是有选择性的。中国也可以找出一千例吃了中药后恢复的。目前还没有能证明因果性的事实，只能看三月份揭盲的结果
是的，纠正一下我的原文，虽然是illness of any duration，但是需要具有出肺部浸润/血氧降低/需要吸氧三个指标之一才可以
Criteria
Inclusion Criteria: [list=1]
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
Male or non-pregnant female adult >/=18 years of age at time of enrollment.
Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
Illness of any duration, and at least one of the following:
Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
Requiring mechanical ventilation and/or supplemental oxygen.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
一直怀疑中国政府故意在downplay这个药的疗效。。。
但是公司应该有monitor啊，疗效数字临床观察都是双盲的医护做的。要是中国会恶意delay这个结果，明明看到非常大的疗效，致死率的区别还不报告，这也不太可能吧。虽然这次屡屡打破下限，但是我觉得还不至于看着救命药的数据还要瞒着。
法国用药个例的新闻主要在法语媒体。没有关于其他治疗的报道。药的来源，给药原则，治疗方案都没有细节。
同怀疑。现在的口径都是吃中药治好的，如果瑞德西伟有效，那就是美国投毒