Agovernment-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.
Gilead made the announcement in a statement Wednesday, stating: “We understand that the trial has met its primary endpoint.” The company said that the National Institute of Allergy and Infectious Diseases, which is conducting the study, will provide data at an upcoming briefing.
The finding — although difficult to fully characterize without any data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.
Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.
But the NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.
The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.
Scott Gottlieb, the former commissioner of the Food and Drug Administration, said he expected there was enough evidence for the agency to issue an “emergency use authorization” for remdesivir.
“Remdesivir isn’t a home run but looks active and can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall,” he said.
The FDA previously issued an emergency authorization for the malaria drug hydroxychloroquine to treat Covid-19, even though at least some studies suggesting the medicine was not effective. “If hydroxychloroquine met [the emergency] standard, then remdesivir would have seemed to cross that line a while ago, especially in the setting of treating critically ill patients,” Gottlieb said.
Remdesivir, which must be given intravenously, is likely to remain a treatment for patients who are hospitalized. But it is also likely that it will be most effective in patients who have been infected more recently, said Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center.
“We know that with most antiviral medications the earlier you give it the better it is.” said Bhadelia, who had experience giving remdesivir as an experimental treatment for Ebola in Africa, where results are less encouraging. That means that better diagnostic testing will be essential to identifying patients who could benefit. “What will be important is that we find people on the outpatient side,” Bhadelia said. “Again, testing becomes important, we want to have them come to the hospital as soon as possible. “
Gilead also released results Wednesday from its own study of remdesivir in patients with severe Covid-19. This study showed similar rates of clinical improvement in patients treated with a five-day and 10-day course of remdesivir, the company said.
“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, in a prepared statement.
Gilead said that its own study in severe patients showed that it may be possible to treat patients with a five-day treatment of remdesivir, not the 10-day course that was used in the NIAID trial.
The company’s study is enrolling approximately 6,000 participants from 152 different clinical trial sites all over the world. The data disclosed Thursday are from 397 patients, with a statistical comparison of patient improvement between the two remdesivir treatment arms — the five-day and 10-day treatment course. Improvement was measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.
The study design means that by itself it doesn’t reveal much about how well remdesivir is working, because there is no group of patients who were not treated with the drug. The conclusion is that the two durations of treatment are basically the same.
Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Medical Center, said he is eager to see the data from the NIAID study but renewed his criticism of Gilead’s severe study for lacking a control group of untreated patients. That would have allowed researchers to make important conclusions about how the drug works that are just not possible now, he said.
“They’ve squandered an unbelievable opportunity,” Bach said. “It’s not going to tell us what to do with 80-year-olds with multiple comorbidities compared to 30-year-olds who are otherwise healthy. We’re still going to be foundering around in the dark, or at least in a dim room, when we could have learned more.”
In the study, the median time to clinical improvement was 10 days in the five-day treatment group and 11 days in the 10-day treatment group. More than half of the patients in both groups were discharged from the hospital by day 14. At day 14, 64.5% of the patients in the five-day group and 53.8% of the patients in the 10-day group achieved clinical recovery.
By MATTHEW HERPER @matthewherper and ADAM FEUERSTEIN @adamfeuerstein
APRIL 29, 2020
ULRICH PERREY/POOL/AFP VIA GETTY IMAGESAgovernment-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.
Gilead made the announcement in a statement Wednesday, stating: “We understand that the trial has met its primary endpoint.” The company said that the National Institute of Allergy and Infectious Diseases, which is conducting the study, will provide data at an upcoming briefing.
The finding — although difficult to fully characterize without any data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.
Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.But the NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.
The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.
Scott Gottlieb, the former commissioner of the Food and Drug Administration, said he expected there was enough evidence for the agency to issue an “emergency use authorization” for remdesivir.“Remdesivir isn’t a home run but looks active and can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall,” he said.
The FDA previously issued an emergency authorization for the malaria drug hydroxychloroquine to treat Covid-19, even though at least some studies suggesting the medicine was not effective. “If hydroxychloroquine met [the emergency] standard, then remdesivir would have seemed to cross that line a while ago, especially in the setting of treating critically ill patients,” Gottlieb said.
Remdesivir, which must be given intravenously, is likely to remain a treatment for patients who are hospitalized. But it is also likely that it will be most effective in patients who have been infected more recently, said Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center.
“We know that with most antiviral medications the earlier you give it the better it is.” said Bhadelia, who had experience giving remdesivir as an experimental treatment for Ebola in Africa, where results are less encouraging. That means that better diagnostic testing will be essential to identifying patients who could benefit. “What will be important is that we find people on the outpatient side,” Bhadelia said. “Again, testing becomes important, we want to have them come to the hospital as soon as possible. “
Gilead also released results Wednesday from its own study of remdesivir in patients with severe Covid-19. This study showed similar rates of clinical improvement in patients treated with a five-day and 10-day course of remdesivir, the company said.
“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, in a prepared statement.
Gilead said that its own study in severe patients showed that it may be possible to treat patients with a five-day treatment of remdesivir, not the 10-day course that was used in the NIAID trial.
The company’s study is enrolling approximately 6,000 participants from 152 different clinical trial sites all over the world. The data disclosed Thursday are from 397 patients, with a statistical comparison of patient improvement between the two remdesivir treatment arms — the five-day and 10-day treatment course. Improvement was measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.
The study design means that by itself it doesn’t reveal much about how well remdesivir is working, because there is no group of patients who were not treated with the drug. The conclusion is that the two durations of treatment are basically the same.
Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Medical Center, said he is eager to see the data from the NIAID study but renewed his criticism of Gilead’s severe study for lacking a control group of untreated patients. That would have allowed researchers to make important conclusions about how the drug works that are just not possible now, he said.
“They’ve squandered an unbelievable opportunity,” Bach said. “It’s not going to tell us what to do with 80-year-olds with multiple comorbidities compared to 30-year-olds who are otherwise healthy. We’re still going to be foundering around in the dark, or at least in a dim room, when we could have learned more.”
In the study, the median time to clinical improvement was 10 days in the five-day treatment group and 11 days in the 10-day treatment group. More than half of the patients in both groups were discharged from the hospital by day 14. At day 14, 64.5% of the patients in the five-day group and 53.8% of the patients in the 10-day group achieved clinical recovery.
https://www.statnews.com/2020/04/29/gilead-says-critical-study-of-covid-19-drug-shows-patients-are-responding-to-treatment/
看上去还没有正式发表 Data。单看五天和十天用药结果有一点差别，五天用药出院率更高些，比十天用药高出10%，也许不具统计学意义。
这个药也许有用，也许没用，但尚需更多临床试验证据去证明有没有用。
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
如家庭用灭火器，火刚起时有用，等烧到了房顶，恐怕就杯水车薪，见不到什么效用了。
中得到有意义的正面数据的。可以想象，关于中药治疗新冠的所有临床观察都夹杂着强烈的主观因素。我不是说中药没起作用，而是说目前的临床研究方式恐怕难以检测出其作用。氯喹可能处于两者中间。
如何客观地，令人信服地检查药物疗效，中医应该多多向西医学习。检验药效的思路和做法太重要了。
还偏偏他们还选择那些重症病患参与做这药的双盲，为什么？ 现在轻证患者人数如此多，根本不必发愁找不到人，不要说3000人了， 几万，几十万人都找得到。
天天说，到处说，不烦？
能不能根据事实说话，不论中医西医，好的就要肯定，不好就要批评？