Vigorous Drug Seeking Action: Gillie Has Expanded Nearly 250 Items In The New Reed Crown Clinical Trial In China.

The hope of the people, Reed, has made new progress in remdesivir.

In February 26th, gilid science officially announced the launch of two new three phase clinical trials to assess the safety and efficacy of Reed in the treatment of new coronavirus pneumonia in adults. Starting from March this year, the two random, open and multicenter studies will be conducted in medical centers in Asia and other countries with more confirmed cases, and about 1000 patients will be enrolled.

Unlike the clinical trials launched by researchers in Hubei, this is the study initiated by Gillie himself. Because Reed Wei Wei Shang has not obtained any permission or approval in any country in the world, individual sympathy medication cases are not enough to determine its safety and effectiveness, and can only be determined by future clinical trials. The test also means that gilid has made a substantial step forward for Reed Xi Wei's subsequent application for listing.

Since there is no specific drug against the new crown virus, after the outbreak, a vigorous "drug seeking" action was launched in China, from research to clinical practice, from scholars to enterprises, from drugs to plasma, from Chinese medicine to diet therapy, the treatment plan was dazzled.

As of February 27th, in twenty-first Century, the economic report reporters found that in the China clinical trial registration center, there were as many as 248 registered trials of new coronavirus, 195 approved by the ethics committee, and 163 intervening studies.

Yan Jiangying, deputy director of the State Administration of drug control, made clear at the press conference of the joint defense and joint control mechanism of the State Council on the morning of February 25th. "The early national drug administration has examined and approved 5 new drugs, such as Reed, Wei and France, for clinical trials of new crown pneumonia prevention and treatment."

A rush to rush into a clinical trial has led to discussions on the design, approval, quantity, quality and so on. A clinical trial researcher told the twenty-first Century economic report that "at present there are too many clinical trials. Whether sufficient research has been done in the early stages of the trial is whether we rush to battle and seize the clinical resources."

The epidemic affects the nervous nerves of the public. Behind the obscurity of the names of Reed, sevir and France, it is the eagerly anticipation of its efficacy. Many "invalid" studies should not seize resources at this time.

Unlike the clinical trials launched by researchers in Hubei, this is the study initiated by Gillie himself. Gan Jun photo

April results

Reed Wei Wei is a nucleotides analogue, which has broad spectrum antiviral activity. In vitro and in vivo animal models show the activity of various new viral pathogens, including Ebola virus, Marburg virus, Middle East respiratory syndrome (MERS) and atypical pneumonia (SARS) virus. Studies on Reed's Wei Wei were carried out in healthy volunteers and Ebola virus infections.

In addition to the similar mechanism, the first new coronavirus in the United States was treated with Reed's administration after exacerbation of the disease. The symptoms improved significantly the next day.

"We think Reed Xi Wei may have expected effect." In the evening of February 24th, WHO China coronavirus joint expert inspection group held a news conference in Beijing, the joint inspection team leader Dr. Bruce Aylward said.

During the special period, the regulatory agencies of various countries also gave the green light to Reed West. China's clinical trial was rushed over and carried out. Gilde said the FDA had approved gilid to launch the new clinical trial after a quick review.

Gilid's view is that the new clinical research expands the ongoing research on Reed xir, including two clinical trials undertaken by China-Japan Friendship Hospital in Hubei, China, and a recent clinical trial led by the National Institute of allergy and infectious diseases (NIAID) in the United States. Gilid donated medicines and provided scientific support for these studies, and clinical trials in China are expected to get results in April.

The clinical trial initiated by gilid will assess the two timing plans of Reed's administration. In one study, some 400 patients with severe clinical coronavirus pneumonia were randomly assigned to receive Reed's treatment for 5 days or 10 days. The second study will be conducted in about 600 patients with moderate clinical symptoms. They are randomly assigned to receive Reed's treatment for 5 days or 10 days or only receive standard treatment.

Merdad Parsey, chief medical officer of Gillie science, said, "the primary concern of Gillie is to quickly determine the safety and efficacy of Reed Siwei as a potential therapeutic regimen for new coronavirus pneumonia. These complementary studies will help us get more extensive global data on this drug in a short time. "

Prior to the launch of Reed's clinical work in China, it was not initiated by Gillie but initiated by researchers. It wasn't originally the data of gildor's application for drug listing, but in February 25th, the Tomas, vice president of scientific virology, Gillie de J. "These two studies are double-blind, placebo-controlled clinical trials, and they can be designed as phase three clinical trials," Cihlar said. This means that if we can see the efficacy of Reed's in one or two studies, these data may become registered data supporting the listing of new drugs. At the appropriate time, we will also decide whether to carry out independent drug safety testing and carry out preliminary and mid-term clinical trial data analysis. This helps us understand the performance of the placebo and the treatment group as soon as possible, so as to ascertain the efficacy and safety parameters of the drug as soon as possible and how to use it in the epidemic.

The researchers also confirmed that "as long as clinical trials are done in accordance with the GCP (management standard for clinical trials of drugs"), there is no problem that these early data will be applied for listing in the future. Moreover, the guiding principles of "real world evidence supporting drug research and development (review)" are issued by the drug administration.

In addition to Chinese researchers and Gillie, the National Institutes of Health (NIH) has launched a clinical trial of Reed levy for new crown virus. In February 25th, NIH announced that the randomized controlled clinical trial was carried out by University of Nebraska Medical Center (UNMC). The first person to be recruited was an American who was repatriated on the "Diamond Princess" cruise ship in Yokohama, Japan, and was repatriated voluntarily.

Tomas Cihlar said, "this clinical trial will expand to the global level. In my view, these three studies will cover a large number of COVID-19 patients to obtain key safety and efficacy data.

Hustle and bustle of clinical research

In addition to the clinical trials of more than two hundred registered clinical trials in China, the largest clinical trial registration center in the world has registered 56 trials with 2019-nCoV on clinicaltrials.gov.

These clinical trials involve not only small molecule antiviral drugs such as Reed, Wei, Fa Pilar Vee, LPN, or ritonavir, but also adalimumab, Shuanghuanglian, Lianhuaqingwen, Xuebijing injection, Xi Yanping injection, glucocorticoid and various Chinese medicines. There are also studies on shadowboxing, soybean water extract and so on. In addition to Wuhan and Hubei, Shanghai, Zhejiang and Guangdong have also been registered in various places.

For today's bustling new crown clinical trial, the Chinese Journal of epidemiology recently published a series of health statistics and epidemiology workers including Chen Feng, Jiang Qing five, and so on, on the scientific, standardized and orderly clinical trial of new coronavirus pneumonia.

The experts who participated in the discussion believe that the sample size of some studies is obviously insufficient, and it is difficult to obtain the expected conclusion because of lack of assurance. If more than 100 studies meet the sample size requirement, it is clear that there are obviously not many patients. In fact, the number of research is increasing. If there is no high quality research design, such as insufficient sample size, unreasonable selection of control group, unsatisfactory evaluation criteria, insufficient integrity and authenticity of data, the efforts of patients, researchers and management departments will be wasted. Ineffective treatment does not mean that there is no side effect, especially at this time, it is not allowed to transfer the risk of ineffective drugs to patients.

The experts who participated in the discussion urged the researchers to be self disciplined. Clinical trials must undergo normal ethical review by research and development units, and objective indicators should be adopted to follow the guiding principles of clinical trial statistics, so as to avoid hasty analysis leading to erroneous conclusions. At the end of the study, the research group should not publish unaudited research results. One is to avoid bias in interpreting the research results. The two is to avoid excessive media speculation affecting the public's expectation of research.

Outside the academia, government departments also come up with norms. In February 25th, the State Council issued the "notice on standardizing the clinical research of new drugs for the treatment of new coronavirus pneumonia in medical institutions". To carry out clinical research on the treatment of new crown pneumonia with "old drugs and new use", while supporting the development of qualified clinical research, "priority should be given to treatment and prevention and control of epidemic diseases, and resolutely prevent the development of prevention and control of the whole epidemic as a result of research affecting the treatment of patients."

WHO's expert Bruce Aylward also mentioned that when visiting Wuhan, Professor Cao Bin, who is in charge of Reed's clinical trial in Wuhan, pointed out that the biggest challenge now is recruiting patients, first because the number of patients is dropping, and the two is "at the same time, they are still carrying out other experimental studies, and these have not seen much hope." So we need to start giving priority to research projects that may help us to save lives faster. "

David Ho, director of the Aaron Diamond AIDS research center and professor of Columbia University School of medicine, said on the above Forum on "scientific battle and disease online", "most of the listed drugs are unlikely to have curative effects on the new crown virus". Some drugs such as polymerase inhibitors and reverse transcriptase inhibitors have been tested for SARS several years ago. Because the design of clinical trials is not perfect, most of them have not been conclusive nor sustainable. Now we face the same challenges. I am worried that many of the clinical trials that are being carried out may not be able to provide definitive information due to design flaws. "

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