Recently, the results of the first clinical study of the highly anticipated anti-epidemic drug, ridasivir, were released.


The results show that 2/3 has been effectively improved and improved. More than half of the ventilator was pulled out within 10 days of treatment, which virtually increased people ’s resistance. Epidemic confidence.


On the other hand, in response to the research progress of Ridsivir, Gilead Science Chairman and CEO Daniel O’Day issued an open letter, He said: “The early data of these 53 patients was not obtained through clinical trials, and the data only covers a few critically ill patients receiving reduxil treatment. The data has certain limitations. In addition, due to the stagnation of enrollment, China has targeted The patient ’s research has ceased. “

Source | qubit

Author | Lei Gang

Title map | IC photo

Remdesivir, redoxivir, the results of the first clinical study are here.

Across hundreds of continents, hundreds of scientists and doctors signed the report, and the report was published by the front page of the top medical journal “New England Medicine” (NEJM).

In the clinical results based on the principle of “sympathetic medication”, 2/3 of the critically ill patients who used Radexivir were effectively improved and improved, and more than half of them pulled out the ventilator within 10 days of treatment.

Although it is not yet the clinical result of the control group, and there are a total of 53 patients in all cases, this is currently the largest result that has been disclosed by ridxivir-and it is also the best result so far.

In late January, “New England Medicine” first published the first effective case of redcive in the treatment of severe new coronary pneumonia, and more clinical and strict control trials have been launched.

And the latest clinical results this time, covering the United States, Canada, Europe and Japan, the results are good.

At least in the treatment of critically ill patients with new coronary pneumonia, the speed and efficacy of redoxivir are worthy of “the hope of the people”.

The effect is further verified

In late January, during the treatment of the first new coronary pneumonia patient in the United States, doctors followed the principle of “sympathetic medicine” and went to Maredsivir. The effect was immediate.

However, because it is an isolated case, there is no strict control group clinical, and redoxivir is not an old drug that has been marketed, so it is not safe to scale up clinical use.

But for critically ill patients, there are many doctors around the worldAfter making a request based on the principle of “sympathetic medicine”, Gilead provided free desivir for treatment. The results of this study are recorded clinical data and results of 53 cases in the United States, Canada, Europe and Japan.

Actually, a total of 61 critically ill patients worldwide received medication this time, starting on March 7. However, because there were 8 patients with missing data, 53 cases were fully recorded.

The specific treatment procedures and methods are consistent with the ongoing clinical trials in China. The longest medication course is 10 days, with 200 mg intravenous injection on the first day and 100 mg daily for the next 9 days. Of these 53 cases, 22 cases were from the United States, 22 cases were from Europe and Canada, and 9 cases were from Japan.

Where:

  • 40 people (75%) received a full 10-day course of treatment;

  • 10 people (19%) received 5-9 days of treatment;

  • 3 people (6%) have less than 5 days of treatment.

    Look at the final result:

    • 36 people (68%) improved after clinical medication; >

      • 30 people (57%) — already used a ventilator, 4 people received ECMO, and 17 patients were extubated after clinical medication;

      • 25 people (47%) The patient was discharged after clinical medication;

      • 7 people (13%) died after clinical medication, 6 of them were severe patients using ventilator grade, and 1 did not have a ventilator on horse.

        The entire 53-severe patients’ medication cycle of Radexivir was up to 10 days, and further observations were made for 18 days thereafter.

        In the entire study period, 32 people (60%) experienced side effects, the most common of which were elevated liver enzymes, diarrhea, rash, renal dysfunction, and hypertension. Among them, 12 (23%) patients had serious side effects, including multiple organ multiple organ dysfunction syndrome, septic shock, acute kidney injury and hypertension.

        Overall, more than 2/3 of the critically ill patients, in the treatment of redoxivir, the new crown symptoms improved significantly.

        It should be noted that the study is not without limitations. On the one hand, there are 53 case data, but too few. On the other hand is the transnational clinical results. Differences in protection and control will also affect the results. Finally, there is no control group.

        However, under the reality of the global pandemic of New Coronary Pneumonia, the rapid and effective clinical improvement ability of redoxive in the treatment of severe diseases is worthy of the expectations of “people’s hope”. And in the report, the researchers also mentioned that in the treatment of severe cases of lopinavir-ritonavir, the 28-day mortality rate is 22%, and the disclosed global new crown severe mortality rate is 17% ~ 78% ……

        So if further results of the efficacy of redoxivir have been proven, it can greatly shorten the treatment time of severe illness, and can cure more people under the pandemic.

        The director of the epidemiology of the Los Angeles Cedar-Sinai Medical Center Hospital who participated in the study commented: Although the efficacy of redcive can not be finalized, for the new patients with severe coronary disease, the results are promising .

        The developer of Redox, the world ’s first antivirus company, Gilead, and its chief medical officer, Merdad Parsey, also said that the results of this batch of data are encouraging.

        But it also emphasized that more rigorous clinical trials are already in progress.

        The most rigorous clinical trial known at present is the control clinical trial led by Dr. Cao Bin of China-Japan Friendship Hospital. The original planned end date is 27th this month.

        So as soon as 2 weeks later, we will be able to know further: Is Redxive really the “hope of the people”?

        Talk about “People ’s Hope”

        Maybe there are friends who are not familiar with this highly anticipated potential medicine.

        A brief review, Remdesivir, Chinese-Chinese translation.

        This is a nucleotide analog prodrug capable of inhibiting RNA-dependent RNA synthase (RdRp), developed by Gilead-this is the world’s first antiviral drug research company.

        This drug in research was originally developed for Ebola virus and is said to be clinically effective for EbolaIf it is not very good but the security is no problem.

        So even though it has not yet been approved in the United States, in accordance with the principle of “compassionate use”, it was used by American doctors in the treatment of the first confirmed patient in late January, but I did not expect an immediate effect.

        The next day after taking the drug, the clinical symptoms improved, and all the symptoms eased in the next few days.

        So on January 31, the top medical journal “New England Medicine” published the process, which attracted more attention in one fell swoop, and the “Red West” development company also quickly reached cooperation with China and decided to launch further clinical trials on the FireWire. test.

        On February 6, Redcive was announced to start clinical trials in first-line hospitals such as Wuhan Jinyintan.

        The first batch of severe pneumonia patients infected with new coronavirus began to take medication.

        According to Gilead’s disclosure, there are two clinical trials conducted in Wuhan. The first is to study and evaluate the therapeutic effect of reduxil for patients who do not show significant clinical symptoms, that is, mild and severe patients.

        Another item is to evaluate its efficacy in severely diagnosed patients.

        The clinical trial leader China-Japan Friendship Hospital also further disclosed the details: the above clinical trial will enroll a total of 761 patients, including 308 patients with mild and moderate disease and 453 patients with severe disease.

        However, there is an interlude in the middle. The Wuhan Institute of Virology, Chinese Academy of Sciences, during this period rushed in the patent for the treatment of the new crown of ridxivir.

        At one time, it also caused heated discussions on both sides of the Pacific.

        But then, the CEO of Gilead responded publicly: treating the disease first, promoting mass production, and not wanting to be involved in patent disputes.

        Later, as clinical trials continued, and as China’s anti-epidemic efforts continued to achieve stage-by-stage successes, the progress of redoxivir began to decrease in popularity.

        However, with the brutal reality of the new global pneumonia pandemic, there are currently more than 1.5 million real-time confirmed cases worldwide. Outside China, the highest number is as high as 70,000 people per day in the United States …

        And even more cruelly, many countries have urgent medical resources and critical wards … even some regions in Italy are beginning to spread the choice of sacrifice to elderly patients.

        Therefore, potential medicines such as ridxivir have changed from the “people ’s hope” of China in January to the “people ’s hope” of the world.

        And in terms of predictable results, the hope of “the hope of the people” is now in China.

        I hope that the upcoming results of the China-Japan Friendship Hospital will also be encouraging, exciting, and hopeful.

        Paper report:

        https://www.nejm.org/doi/full/10.1056/NEJMoa2007016