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Reed Wei Wei Treatment Of New Crown Pneumonia Negative Effect? The Difficulty Of Clinical Trials Under The Global Epidemic

2020/4/25 13:34:00 0

Reed Wei WeiNew CrownPneumoniaEffectGlobalEpidemicClinical Trials

Reed Wei, a potentially effective drug that is considered to be the most promising treatment for new crown pneumonia, has unveiled the results of its clinical trial in a slightly more dramatic way.

In the United States local time on April 23rd, media reported that Reed Wei Wei in a clinical trial effect is disappointing, originally good trend Geely science stock price plunge suddenly, once dropped more than 8%, fell 4.34%.

The decline is due to a media accident on the official website of the WHO (WHO), which has been deleted. The matter is confirmed to be true. The who said, "the author provided a draft of the document to who, which was not posted on the website, and was deleted after the error was found. The manuscript is under peer review. We are waiting for the final version. "

Subsequently, Merdad Parsey, chief medical officer of gilid, said on behalf of the company that it should return to the incident: "WHO website published the first clinical research information in China. This study evaluated the use of Reed Siwei in the treatment of severe cases of new coronavirus pneumonia. This information has been deleted because the researchers did not permit the publication of the results. In addition, we believe that the article contains an inappropriate description of research. Due to the low entry rate, the study was terminated early, so its data are insufficient to support statistical conclusions. In itself, the results of the study are non conclusive, although the trend of data suggests the potential benefits of Reed Wei Wei, especially among those who received early treatment. We are informed that the existing data have been submitted for peer reviewed releases, and will see more detailed information about the study in the near future. "

Because of the efficacy shown in "sympathetic use", all sectors of the community have great hopes for Reed and hope that their clinical trials will be blinded. Although the "accident" is not officially announced, it seems that Reed has lost the aura of "special effects". On the other hand, it also faces the dilemma of this regrettable test result: why is the number of people in Wuhan far less than expected? How to carry out high-quality randomized clinical trials under hundreds of clinical trials?

Entry stagnation

The result of the "misoperation" announcement is Reed's first clinical trial in the world for new crown pneumonia. It is a randomized, controlled, double-blind clinical trial conducted in China, and the results are negative and negative. Among the 237 patients diagnosed with new crown pneumonia, 158 were given Po Reid Nelisiwe and compared their progress with the remaining 79 patients.

Merdad Parsey's statement confirmed that this is Reed's study of severe coronavirus pneumonia in critically ill patients. The results showed that Reed had no relationship with clinical improvement time compared with standard diagnosis and treatment. 28 days later, the mortality of the test group treated with Reed's Wei was 13.9%, while that of the control group was 12.8%, the difference was not statistically significant. 18 patients (11.6%) withdrew from the trial due to their obvious side effects.

Because of the lack of context control, more complete information and detailed examination, the results of the test are not yet known.

In April 24th, Wang Yeming, one of the team members of the test team, said in reply to the twenty-first Century economic report enquiries, "we will issue a response to our concerns at the same time when the article is online."

In fact, the two new crown clinical trials carried out by Reed Wei Wei in China have been "terminated" and "suspended".

In April 10th, the new England Journal of Medicine (NEJM) published a report on the use of "Reed sympathies". Data showed that most of the hospitalized patients with severe complications of 53 new coronavirus pneumonia received clinical improvement. But this is not the result of rigorous clinical trials. The data are limited because the size of the medication queue is small and the follow-up time is relatively short. The nature of the sympathetic medication itself may lead to data loss and lack of a randomized control group.

At the time, in response to the progress of Reed Siwei in the world, the Daniel O 'Day, director and CEO of gilid, released an open letter saying that at present, seven clinical trials of Reed Siwei have already started. It is expected that at the end of April, Reed will get preliminary data for the study of critically ill patients, but in China, the study of severe patients has stopped because of the stagnation of the group.

    In April 15th, Cao Bin, director of the Department of respiratory and critical care medicine of China-Japan Friendship Hospital, updated the information of the two trials in the world's largest clinical trial registration center. The critical state was updated to "terminate", and the mild to moderate state of illness was updated to "pause". The reason is "the popularity of COVID-19 has been well controlled in China. At present, no eligible patients can be admitted. Enter. " The two tests were registered in February 6th and 5th.

Clinical difficulty

Whether Reed was disappointing, and needed more clinical data and official blindness.

In the face of new emerging respiratory infectious diseases, it is very difficult to quickly and clearly identify effective drugs. It is necessary to focus on the most valuable resources and give priority to several potential drugs. In this situation, how to design clinical trials that are scientific, advanced and feasible to obtain high-quality data for guiding treatment is more challenging.

One of the problems with Reed in Wuhan is that too many clinical trials have seized the resources of patients. WHO's expert Bruce Aylward mentioned that when inspecting in Wuhan, Cao Bin said the biggest challenge is recruiting patients, first because the number of patients is decreasing, and two is still conducting other experimental studies.

As of April 24th, in twenty-first Century, the economic report reporters found that the "new coronavirus" registered up to 587 items in the China clinical trial registration center.

"These hundreds of projects may not be able to produce results in the end." Li Jin, director of Oncology Department of Dongfang Hospital Affiliated to Tongji University, Shanghai, said in an interview with an economic reporter in twenty-first Century. "Many clinical research processes may not be fully in line with specifications, and some patients are too few, and some even participate in several clinical trials at the same time. This is a serious violation of the GCP principle."

The two is Reed Siwei's entry conditions are "harsh", one of the screening conditions is that the patient did not receive any experimental treatment for new crown pneumonia in the past 30 days.

      Wu Chao, deputy director of Nanjing Gulou Hospital and director of infectious diseases division, who supported the treatment of severe acute diseases in Wuhan, told reporters on twenty-first Century economic report that "when the outbreak of new crown pneumonia occurred, no one had any treatment experience. At the very beginning, with reference to the guidance of the time, almost all patients had used more than one antiviral drug. When Reed clinical trial began, Most of the patients in early stage did not conform to the conditions of entry. The number of new patients is decreasing. All doctors and nurses participating in clinical research should undergo GCP related training and strictly operate according to the experimental design and process. At the same time, there are corresponding management requirements and supervision in clinical research process, especially the combination of medication. A perfect, scientific and rigorous clinical research is not so easy.

Reed Wei Wei in Wuhan clinical trials were divided into two groups, one group for the general type of patients, a group of critically ill and critically ill patients, one of the severe patients into the group condition is from the onset of the first day of onset of onset of symptoms to 12 days of patients, the general type of patients for 8 days. The main reason for the limitation of time is that most patients have the most virulent virus in this time period, and no antibody has been produced.

At the beginning of the project, there were a small number of medical institutions involved in cooperation, mainly in the Jin Yin Tan Hospital and Tongji Hospital. However, during the process of advancing, it was found that it was very difficult for the patients to enter the group. The reason was that when the project started, it had entered the February. At that time, the onset time of many patients in Wuhan had been over 12 days or 8 days, which could not satisfy the entry conditions. Since then, the project has further expanded cooperative medical institutions, but the proportion of critically ill patients has dropped significantly. Severe and critically ill patients are in serious condition, which is too risky for clinical trials, and few patients can be screened.

While the duration of the disease in the ordinary patients is shorter, one of the requirements is that the nucleic acid test is repeated many times. However, the efficiency of nucleic acid detection is not high at that time, and many patients in the queuing nucleic acid detection time will soon become cloudy and 2-3 days after treatment. At the time, for ordinary patients, with the improvement of the understanding and treatment of the disease, there are many ways that can be adopted in clinic.

Patients and clinicians have high hopes for this clinical trial. "At that time, everyone was lucky to see who would succeed in the group." A clinician pointed out to the twenty-first Century economic report, but all kinds of practical constraints did not lead to a successful team.

For drug efficacy, Wu Chao pointed out: "first, all antiviral drugs may be useful at the early stage of the disease, alleviate some symptoms or improve the progression of the disease. Once the disease exceeds 5 days or a week, the value is not great. Two, AIDS, SARS, avian influenza and H1N1 are all antiviral drugs that are not effective. The drugs currently developed are mainly nucleoside analogues or protease inhibitors, which act as a site for replication of a virus. So far, the successful treatment of specific anti viral drugs comes from the treatment experience of hepatitis C. The popularity of the new crown virus has only been known for several months. It has not fully understood the structure, replication, key protease sites and mutation of the virus. We have not yet had time to understand its viral replication cycle and link, and have skipped many preclinical basic research. .

 

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