There will be special drugs for new crown pneumonia. From now on, 270 patients will be enrolled in clinical trials

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 There will be special drugs for new crown pneumonia. From now on, 270 patients will be enrolled in clinical trials


On the same day, it was reported that the clinical trial of ridcivir in the treatment of new coronavirus (2019 ncov) will be launched in Beijing China Japan Friendship Hospital on February 3.

On February 2, the drug evaluation center (CDE) of the State Food and Drug Administration of China officially accepted the application for clinical trial of ridcivir. According to foreign media reports, the U.S. public safety and Health Department agreed to exempt the patent of the drug with the approval of trump, and urgently disclosed the molecular structure of the drug to China until April 27.

According to the plan, the trial will start on February 3, with a total sample size of 270 cases, and enter the group of patients with mild and moderate new crown pneumonia.

This time, is the life-saving drug against 2019 ncov really coming?

Can we directly start clinical phase III by skipping multiple links?

Radcivir is the first drug developed by Gilead company for Ebola virus. It has completed phase I and phase II clinical trials abroad.

However, Geely said that at present, rydsiwei has not been approved for listing in any country, and its safety and effectiveness for 2019 ncov have not been confirmed. It is a drug under development, and there is no data for 2019 ncov.

This time, the clinical trial to be launched in China is a phase III, randomized, double-blind, placebo-controlled trial, aiming to determine the safety and effectiveness of radcivir in the treatment of 2019-ncov.

It is understood that the total sample size of the trial is 270 patients, who are enrolled in the group of patients with mild and moderate new crown pneumonia, led by Professor Cao Bin of China Japan Friendship Hospital, and expected to start on February 3 and end on April 27.

Generally speaking, to change a different virus, we need to do clinical experiments again. But this time, China skipped the phase I and phase II trials for 2019 ncov, and launched phase III clinical trials in an emergency.

Li Taisheng, director of infection department of Peking Union Medical College Hospital, said in an interview with China Science Daily that the cell experiment of radcivir against Ebola virus is effective and the clinical safety is acceptable, but the clinical effect data is not available yet.

However, if the emergency start of phase III in China is approved by the relevant national management department and reviewed by the ethics committee, it is possible to do so within a certain range.

A senior executive of a well-known pharmaceutical company in China also said that the phase II clinical treatment of ribavir for Ebola virus has been completed, at least indicating that the side effects are controllable. The results of the clinical trials of Ebola virus may be borrowed into the new coronavirus pneumonia, so you can apply for exemption and enter the phase III clinical directly.

It is reported that radcivir can inhibit the epidemic and zoonosis of coronavirus. The mechanism of action on Ebola virus is to inhibit the RNA polymerase RdRp of coronavirus.

Gilead said that although there is no anti-virus data to show the activity of radcivir for 2019 ncov, in vitro and in animal models, radcivir has confirmed its activity for the viral pathogens of atypical pneumonia (SARS) and Middle East respiratory syndrome (mers). The latter two are also coronaviruses and are very similar in structure to 2019 ncov.

Can it really be a lifesaver?

The total sample size of phase III clinical trial is only 270 cases. Can we ensure the effectiveness of the drug? In this regard, experts believe that caution is needed.

Li Taisheng said that at present, radcivirs test belongs to the research of new drugs, and the existing risks should be considered. The report of the United States is to cure a patient. In fact, it is a case report and cannot be promoted.

We are very careful against viral treatment. Even for klitschke, we are very cautious. Klitschke was the first to treat AIDS. It has been used in the world since 2000, and in China since 2008. It has been 12 years since then.

However, there is not enough evidence to prove the existence of effective anti-2019-ncov drugs, so it is also appropriate to use Coriolus for severe patients, because the use of it will produce diarrhea and other gastrointestinal adverse reactions. Li Taisheng said.

According to the executives of the above-mentioned pharmaceutical companies, its risky to test more than 200 samples. How many cases are needed? Each drug is different from each disease. But this time, the relevant departments are willing to take a risk to approve it, because the biggest benefit of this drug is to know if its effective after a test, and its immediate.

Approval of new drugs used to be a very lengthy process, but this time it may be a special task. At present, the rest of the world does not have this pressure and motivation, but China does. The drug company executives said.

Can American drugs be listed in China?

The executives also said that for Gilead, this is an opportunity for ridsiway to go public.

It is necessary to complete enough clinical cases to be approved for marketing. Once the epidemic has passed, there will not be enough cases to complete phase III clinical. The reason why the drugs were not developed was that there were not enough patients to complete phase III clinical treatment. So they should seize the time, make use of enough patients now, and finish the clinical work as soon as possible. He said.

He said that in the past, there were cases in which American companies were researching drugs to be listed first in Europe and Japan, but at present there is no precedent in China, maybe this can set a precedent..

Can Ridgeway use it before it goes on the market?

Gilead said it is working closely with global health agencies to provide in-process drug ridcivir for experimental treatment to support the 2019-ncov outbreak. So, apart from 270 patients who participated in the trial, is it possible for other patients to take the drug before readcivir officially goes on the market?

It starts with a system called compassionate medicine.

The reason why the new coronavirus pneumonia patients cured in the United States can use this drug is due to the sympathetic drug system in the United States.

(function() {(window. Slotbydup = window. Slotbydup| []). Push ({ID: u5811557, container: ssp_, async: true});)) (); the so-called compassionate drug refers to that in some special circumstances, when patients cannot obtain clinical trial drugs through participating in clinical trials, they are allowed to use the drugs that have not been approved for marketing in the institutions conducting clinical trials to give urgently needed patients. In December 2017, the State Food and Drug Administration released the Chinese version of the sympathizing drug system - measures for the administration of extended sympathizing use of drugs for clinical trials (Draft for comments). According to the draft, the target population of Chinas sympathizing drug system is patients with diseases that are life-threatening or seriously affect the quality of life of patients requiring early intervention and without effective treatment. Moreover, this method stipulates that the registration applicant shall apply to the drug evaluation center of the State Food and Drug Administration for the development of extended clinical trials, which can only be implemented after being approved. However, due to the draft, it is not known whether more patients can use the drug before it goes on the market. Source: responsible editor of China Science Daily: Li Chao, nb12814

The so-called compassionate medication refers to that in some special cases, when patients can not obtain the drugs for clinical trials by participating in the clinical trials, they are allowed to use the drugs that have not been approved for marketing to the urgently needed patients in the institutions that carry out the clinical trials.

In December 2017, the State Food and Drug Administration released the Chinese version of the sympathizing drug system - measures for the administration of extended sympathizing use of drugs for clinical trials (Draft for comments).

According to the draft, the target population of Chinas sympathizing drug system is patients with diseases that are life-threatening or seriously affect the quality of life of patients requiring early intervention and without effective treatment.

Moreover, this method stipulates that the registration applicant shall apply to the drug evaluation center of the State Food and Drug Administration for the development of extended clinical trials, which can only be implemented after being approved.

However, due to the draft, it is not known whether more patients can use the drug before it goes on the market.