Zhong Nanshan speaks out! All research on Remdesivir has been suspended in China, but good news has come from abroad. The reason behind this is lamentable.
The suspension of clinical research on remdesivir in China is related to our country's current control of the epidemic.
Text | Li Shuaifei
Is there still hope for Remdesivir, known as the "people's hope"?
In China, the situation does not seem optimistic.
According to a report by Seeking Alpha on April 15, the clinical study of remdesivir in China for patients with mild and moderate COVID-19 (new coronavirus pneumonia) was suspended due to "low enrollment rate"; according to the information displayed on the clinical trial registration website ClinicalTrials.gov, the status of this study was updated on April 15 and was shown as "Suspended".
Earlier, the clinical trial of remdesivir for severe COVID-19 patients in China had also been terminated - this is not good news for remdesivir.
However, outside of China, the situation with remdesivir is completely different, and there is indeed hope.
Remdesivir in China: People’s Hope
Did it fail?
Remdesivir is an experimental drug for the Ebola virus developed by Gilead Sciences, Inc., the world's leading antiviral drug research company and one of the largest biotechnology companies in the United States. It can inhibit RNA synthetase (RdRp) - and RdRp exists in the new coronavirus.
On January 31, 2020, the New England Journal of Medicine (NEJM) reported in its short report section the first successful cure of a patient diagnosed with COVID-19 in the United States. According to the article, the patient's condition worsened after isolation and treatment, and after receiving remdesivir, the effect was immediate.
After this report reached China, it gave hope to the people who were suffering from the epidemic, and thus remdesivir was called "the hope of the people."
On February 2, the Drug Review Center of the National Medical Products Administration officially accepted the clinical trial application for remdesivir.
On February 5, the Ministry of Science and Technology held a launching meeting for the emergency research project "Research on Remdesivir for the Treatment of 2019 Novel Coronavirus Infection" at Wuhan Jinyintan Hospital. The project includes two clinical studies:
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First, evaluate the efficacy of remdesivir in patients who have been diagnosed with novel coronavirus and have been hospitalized but do not show significant clinical symptoms, that is, for mild and common patients (NCT04252664);
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The second is to evaluate the efficacy of remdesivir in confirmed patients with more severe clinical symptoms, that is, for severe patients (NCT04257656).
A total of 761 patients were enrolled in these two studies, including 308 mild and moderate patients and 453 severe patients. At that time, Professor Cao Bin of the China-Japan Friendship Hospital introduced that this study will conduct a strict randomized double-blind trial to determine the efficacy and safety of remdesivir in coronavirus pneumonia.
At the same time, Gilead also reached an agreement with the Chinese health authorities to support the two clinical trials - providing the drugs needed for the research free of charge and providing support for the design and conduct of the research. However, at the time, Gilead expected to obtain preliminary data from the study of remdesivir for severe patients by the end of April.
In the next two months, remdesivir entered into clinical trials conducted by Wang Chen and Cao Bin's team from the China-Japan Friendship Hospital at the Wuhan Jinyintan Hospital - but due to the long clinical trial cycle, no relevant news has been announced.
So far, no data from clinical trials has been released.
However, on April 11, Gilead announced that according to the information it had obtained, the clinical research of remdesivir in the severe group in China was forced to stop due to a stagnation in enrollment. After this news was released, Professor Cao Bin, who led the trial, said in an interview with Caixin that the data of the severe group of remdesivir was being analyzed and studied.
On April 15, the clinical trial registration website ClinicalTrials.gov showed that the two clinical trials of remdesivir conducted in China, including two trials for severe patients and two trials for mild and ordinary patients, were updated to the latest status of "suspended".
The researchers said the trial was stopped early because the "new coronavirus epidemic in China has been well controlled" and "it is impossible to recruit qualified patients." At the same time, Gilead also responded to Yicai Global on April 16:
We have been informed that two clinical studies of remdesivir led by Chinese research institutions for severe and mild to moderate patients with novel coronavirus pneumonia have been terminated early due to low enrollment.
In response to this outcome, some commented: Have the people’s hopes been dashed?
Outside of China, the situation of remdesivir
There are still variables
Compared with China, the situation of remdesivir in the United States is quite different.
In mid-to-late February, the epidemic was gradually brought under control in China, but it began to spread in other countries and regions. On February 26, the number of newly confirmed cases of novel coronavirus pneumonia worldwide exceeded the number of newly confirmed cases in China for the first time. The US CDC also held a press conference in late February to announce the latest confirmed case of community transmission in the United States.
Against this background, clinical trials of remdesivir began on a large scale abroad.
On February 21, the University of Nebraska Medical Center registered a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) to conduct a Phase II clinical trial of remdesivir at 50 sites around the world. It plans to recruit 394 patients and is expected to be completed on April 1, 2023.
On February 26, Gilead announced the launch of two Phase III clinical studies to evaluate the safety and efficacy of remdesivir in the treatment of adult patients with novel coronavirus pneumonia.
Unlike the two randomized double-blind controlled trials conducted in China, the two clinical trials conducted by Gilead adopt a randomized, open, multicenter research method. They will be mainly conducted in medical centers in Asia and other countries with a large number of confirmed cases around the world. The study will evaluate two dosing schedules for intravenous administration of remdesivir - the results are expected to be announced in May.
At the time, Gilead Sciences Chief Medical Officer Dr. Merdad Parsey said:
Gilead's primary focus is to quickly determine the safety and efficacy of remdesivir as a potential treatment for COVID-19. These complementary studies will help us obtain more extensive global data on this medicine in a short period of time.
On March 24, the U.S. FDA's official website showed that Gilead's remdesivir was granted orphan drug status for the coronavirus disease (COVID-19); however, on March 27, Gilead announced that it had submitted an application to the FDA to cancel the orphan drug status granted to remdesivir.
On April 10, the New England Journal of Medicine (NEJM) published online the results of a retrospective analysis of the compassionate use of remdesivir. Among the 53 severe COVID-19 patients from the United States, Japan, Canada, and Europe included in the analysis, 68% (36/53) of the patients improved in terms of oxygen support type, and 7 patients (13%) died.
At the same time, the study also observed 60% of side effects, and some patients experienced serious side effects, so the drug needs to be used under medical conditions.
In this regard, the China Pneumonia Research Network (CAP-China) cited the views of experts such as Cao Bin and believed that the above results do not constitute effective proof of the efficacy of remdesivir. Professor Lan Ke, director of the State Key Laboratory of Virology at Wuhan University, said that for now, we can only be cautiously optimistic about the effect of remdesivir in the treatment of COVID-19, and look forward to the release of the results of multiple double-blind, randomized controlled clinical trials in the near future.
It is worth mentioning that the study itself also stated in its conclusion: The judgment of efficacy depends on the results of the randomized, placebo-controlled trial of remdesivir currently being implemented.
The latest news about the efficacy of remdesivir comes from a report by the American medical news website STAT. The report cited a report from a medical researcher at the University of Chicago, saying that among the 125 patients with COVID-19 who participated in the clinical trial, most of the patients' fever and respiratory symptoms improved rapidly and were discharged from the hospital in less than a week, with only two people dying.
In response to this news, Gilead China also made an official response on April 17:
The reports from anecdotes are encouraging, but they are not statistically sufficient to determine the safety and effectiveness of remdesivir as a treatment for COVID-19...Any conclusion from the trial requires analysis of all the data. We look forward to receiving data from multiple studies over the next month to help determine the safety and effectiveness of remdesivir in treating patients with COVID-19.
In other words, Gilead does not dare to make a final conclusion on the effectiveness of remdesivir for COVID-19.
Leifeng.com Summary
It should be noted that the suspension of two studies on remdesivir in China is not an isolated case.
In fact, as of April 16, 598 clinical trials for the new coronavirus in my country have passed project approval, but more than 40 projects have been cancelled, including the suspension of two clinical trials of remdesivir in China.
In this regard, Zhong Nanshan, leader of the National Health Commission's high-level expert group and director of the National Clinical Research Center for Respiratory Diseases, said in an exclusive interview with China Science Daily:
Many studies were cancelled because no one expected China to control the epidemic so quickly. There is no chance to conduct large-scale clinical drug or treatment research in China now. The first wave of the epidemic has passed, and we are now controlling the second wave relatively well, especially under the strict framework of group prevention and control.
It can be seen that the suspension of clinical research of remdesivir in China is indeed related to our country's current control of the epidemic.
However, outside of China, the development of the epidemic is becoming more and more worrying, which may give the "people's hope" some hope - although fundamentally, we are more looking forward to the day when people no longer need this "people's hope".
However, as of 8 a.m. Beijing time on April 17, the number of confirmed cases of new coronary pneumonia worldwide has exceeded 2 million, with a specific number of cases being 2,034,802.
References for this article:
https://www.yicai.com/news/100595985.html
https://www.yicai.com/news/100597625.html
https://www.who.int/emergencies/diseases/novel-coronavirus-2019
https://www.leiphone.com/news/202003/LAU0BssmU5sBNRFB.html
https://mp.weixin.qq.com/s/9rvR4htMrpXVFQO0rKoR9A
https://mp.weixin.qq.com/s/F6l1YDeSSGPz7JqWsdsHLw
https://mp.weixin.qq.com/s/u0kKGeHtkknxxyBRyByEZw
https://mp.weixin.qq.com/s/qZQo_24tMp3tC2VkNt4zdA
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