On the evening of April 29, many clinical trials of Redswell were released densely.Cao Bin, deputy dean of China -Japan Friendship Hospital, and Wang Chen, dean of the Chinese Academy of Medical Sciences, and others published in China ’s clinical trials published in Liuye Dao Magazine. Compared with the placebo group, the Redsi Weixi group average in clinical improvement time in terms of clinical improvement.Shortening by 2 days; the average time of mechanical ventilation is shortened by 4 days, and the above differences are not statistically significant.The 28 -day mortality, oxygen therapy time, hospitalization time, nucleic acid load, and virus rotation yin rate of the two groups of patients had no statistical differences.

However, the preliminary test results of the National Institute of Health showed that Rodsovir shortened the time of the patient's recovery and received the rehabilitation speed of patients with advanced crown pneumonia and lung patients in the drug treatment of the drug.EssenceThe person in charge of the research institution says that Redsie has a clear and positive effect in the course of the patient's disease recovery.Instead of news, Geely's stock with this drug rose more than 8%.

Redsie is an antiviral drug that has not been approved. It was originally planned to treat Ebola virus, but became the most watched research therapy during this new crown epidemic.However, Rydecwell, known as the people of the people because of the homophonic sound, has the progress and results of its clinical trials like roller coasters, and reverse many times between hope and disappointment.

The results of Chinese clinical trials show no efficacy

China is the earliest country to launch the clinical trials of Redsie. As early as in early February this year, China launched two III clinical trials for patients with severe and mild/symptoms, and plans to recruit more than 700 subjects.Since February 6, 10 hospitals in Wuhan City, Hubei Province have launched clinical trials for patients with severe illnesses. This is the world's first clinical trial based on random, double -blind, and placebo -controlled clinical trials.EssenceAfter March 12, the qualified subject was not screened.

On April 15th, news of the update of the world's largest clinical trial registration database showed that the clinical trials of Rydecwie's clinical trials for patients with severe illnesses have been terminated on March 30, and clinical trials on patients with mild and neutroders are the latest.The state is suspended.The database states that the test has been unable to recruit qualified patients due to the control of China's new crown epidemic.

At the end of April, it was when the clinical trials were unveiled.On April 23, according to the US medical industry media Stat report, the World Health Organization (WHO) official website released a study abstract on the same day, revealing that the results of clinical trials in China show that Redsie has no treatment effect MDASH; MDASH; 237 subjects.Among the patients, 13.9%of the patients using Rydecwell were 12.8%.Subsequently, this study abstract was deleted.Gilder responded that the researchers did not allow the results.

On April 29, the results were officially published in the well -known medical journal Liuye knife.From February 6th to March 12th, 237 test patients were randomly distributed into two groups, of which 158 were treated with Redsie and 79 people used placebo.However, with the summary of the research that has flashed on the WHO website, Redsovir has not brought statistically significant effects.The neutral clinical improvement time of the Ridi Xili group is 21 days and the placebo group is 23 days.In terms of safety, the incidence of adverse reactions in the treatment group and the control group is 66%and 64%, respectively.After the test began, a total of 22 patients withdrawn from the test due to adverse reactions, including 18 people and 4 people in the placebo group.

Most of the news about Redsovir is positive.The first formal report on the efficacy of Rydewe's efficacy was released from April 11 in New England Medical Magazine.Data in the case of sympathy showed that after using Redsie, 53 of the 53 patients with severe and critical critical crowns from the world were alleviated by 36 (68%) patients, and the death rate was 13%.Especially among the critical patients who need to accept mechanical ventilation, Ryde Xili's treatment controls the mortality at 18%.

On February 26, Gilit launched two clinical trials of Redsie in the world. In the new crowns in the United States, Asia and Europe, 180 clinical centers were established.Clinical Trials.On April 16, according to STAT reports, most of the 125 test patients were discharged within 6 days of treatment in the clinical trial of the University of Chicago.There were 113 of these patients, and only two died.Affected by this news, Geely's stock price soared 12%, and it led to a sharp rise in the entire stock market in the United States.

On the evening of April 29th, Beijing time, Gillar announced a random open label clinical trial named Simple, led by it. The test was included in the 397 blood oxygen level but does not require mechanical ventilation.Xiwei ’s 5 -day and 10 -day drug treatment plan shows similar clinical improvement effects.Specifically, the median time of the 5 -day treatment group was 10 days, and the median time of the 10 -day treatment group's clinical improvement was 11 days; the mortality rates of the two groups were 8%and 11%, respectively.At the same time, in the two treatment groups, Redsie is generally tolerated.

However, the above tests are non -controlled tests.If the control group is not set, we cannot know whether the patient's condition is because of the curative effect of Rydeci itself, or the natural transition of the new crown disease or the comfort of Redsie.The Cao Bin team made the above comments and pointed out that the problem needs to be answered in the future random double -blind control research.

In the early morning of April 30, the National Institute of Allergic and Infectious Diseases (NIAID) of the National Institute of Health (Niaid) announced a preliminary result of random, control, and double -blind trials of 1063 patients. Compared with the placebo group, RuiDecyway has obviously shortened the time required for the recovery of the patient's clinical symptoms. From 15 days to 11 days, the decrease was 31%, which was significantly different.8%decreased to 5%, but did not reach significant differences.

This research was funded by Niaid and recruited a subject from 68 locations from 68 locations in the United States, Europe and Asia on February 21.The independent data and security monitoring committees responsible for supervision and testing held a meeting on April 27 to inform researchers that Redswabi was more effective.Niaid Director Anthony Middot; Foch's attitude is more optimistic. He believes that this is an important concept verification, indicating that Redsie has the ability to block the replication of the new crown virus.However, he also reminded that this result requires appropriate peer review.He said that Redsie would be a standard treatment, but this was just the beginning. Follow -up will be based on Redsie, add other therapeutic drugs.

Sino -US clinical trial results are different from different standards

Eric Middot, a professor at Duke University Medical Center; Peter Sen believes that the number of Chinese research groups is too small, but if REDIV is a special effect medicine, it should also be displayed in this study.Middot, a global health expert at Stanford University; Barry said that there are insufficient sample defects in China, but if you use high doses of high doses or earlier administration in research, there may be different results.

Cao Bin and others also proposed in the paper that due to the insufficient number of patients in the group, the sample volume that did not reach the presets caused insufficient statistical grasp.In order to better understand whether Rydeville can provide significant clinical efficacy, more evidence from the ongoing clinical trials is needed.

John Middot, Professor of Medical Statistics at the University of Edinburgh and director of the Clinical Research Center; Norrie commented on Cao Bin and others on the Liuye knife on the same day, and pointed out that the test dual blindness, placebo control, multi -center, random research designGood, and the test is well executed.However, the test ends in advance, resulting in insufficient research support and conclusions that cannot give a certainty.It can neither confirm that Redsie can produce at least a certain clinical benefit, nor can it exclude the effectiveness of Redsie.

Regarding these contradictory results, science magazines believe that whether it is because of design or test suspension, the current research published does not have the research of Niaid.The new group subjects cannot evaluate the drug appropriately.However, whether this study of Niaid in the United States can connect the efficacy of drugs with its direct role in the virus.

Although the public will feel that the clinical trials of both China and the United States have different results, I personally think that they are basically consistent, and I am not surprised by the results provided by Niaid in the United States.Overall, Redsie is not a special effect.Ding Sheng, dean of the School of Pharmacy of Tsinghua University and director of the Global Health Drug Research and Development Center, told China News Weekly that from the research of both parties, the mortality rate of the subjects can be seen significantly.He further explained that the interpretation of the test results is based on additional conditions. The so -called clinical effect of any drug is not an absolute judgment. The influencing factors include how to define clinical endpoints, how to choose the definition of the group group, and so on.

In an interview with the media, Cao Bin also emphasized that their research is essentially different from that of Niaid's research. The reason is that the differences in evaluation indicators.Standards are not suitable for China.Cao Bin believes that our ending evaluation is a comprehensive indicator. For example, it is more comprehensive and more comprehensive and more comprehensive like the university.

Wang Yeming, a physician of the Medicine and Critical Medical Medicine of China -Japan Friendship Hospital, is the first author of the study. He told China News Weekly that the end of the ending of severe respiratory virus infectious diseases has not reached a consensus.The mortality rate is a hard indicator. Everyone admits it, but the disease mortality rate of patients with severe respiratory virus infection is not high, as is new crown pneumonia, so it is not applicable; the clinical symptoms of patients are generally used by patients with mild patients.Among the people who are not so high but need to be admitted to the hospital, although the US FDA suggested that the main endpoints should include symptoms, signs, hospitalization time, clinical recovery time, breathing support and mortality of the disease.None of them are unified.

In terms of entry standards, for example, the Chinese test requires the symptoms of patients in the group within 12 days, and other experimental drug treatment is not received within 30 days. The National Institute of Health is not required.Ding Sheng said that the later the patients joined the group, the more the lower reaches of the downstream body after the viral infection would cause an immune response, and the more complicated the condition would be.Therefore, the more the drug's role may be played by blocking virus copying alone.

Regarding whether the requirements of Chinese clinical trials on the subjects are strict, Wang Yeming explained that their first papers published in the new crown pneumonia published in Liuye Dao Dao and follow -up studies showed that patients from increasing illness to severe or critical illnesses probably probably probably probably probably.At about 10 to 12 days, it is reasonable to set up for 12 days. It is hoped to let patients use antiviral drugs as early as possible.After March 12, they cannot recruit suitable subjects.At that time, more patients in Wuhan were in the recovery period. Even if the time limit was released, it would be difficult to expand into the group, which would be difficult to evaluate the results of the drug clinical trials.

In response to patients with eliminating antiviral drugs, Wang Yeming clarified that they only excluded patients participating in other drug clinical trials and did not rule out subjects who received standard treatment but did not participate in other clinical trial projects.The same patient cannot participate in two clinical trials at the same time.

In general, in the aspect of lsquo; old medicine new use rsquo; there are no particularly effective methods.The situation of Redsovir is basically the case, after all, old medicines are not targeted drugs.Ding Sheng said that there will be more and more results about the results of the clinical research of Redsovirway. These results can help us understand how to better understand this drug, including the effectiveness of the segmented crowd.Can it be used with other drugs and so on.

For example, although there is no obvious effect, the articles of Cao Bin and others have also found that for patients with the disease in 10 days and within, the clinical performance time of the Redsie Group is better than the placebo group.Wang Yeming and others wrote that although the results of the test did not show the expected efficacy of Rydexi in the treatment of new crown pneumonia, it may still have potential value in early treatment and combined with other antiviral drug treatment, which needs to be further studied and discussed.

In order to cope with this disease, the efficacy of drugs to reach this level cannot meet the most urgent needs of the treatment of new crown diseases. It is still necessary to find better and more targeted drugs.Ding Sheng said.