It will provide first-hand data for "Class B and Class B management". China's first large-scale real world study of anti COVID-19 drugs launches clinical | COVID-19 | Class B
Recently, China's first large-scale real world research on anti COVID-19 drugs on the market was launched in Beijing. This study, involving more than 100 large hospitals and primary medical institutions in 30 provinces, autonomous regions and cities across the country, will include real data of nearly 40000 COVID-19 patients. The study will reflect the clinical program, follow-up mechanism, medical expenses and other aspects of COVID-19 treatment in China, and further explore the efficacy, safety and pharmacoeconomic value of anti COVID-19 drugs, so as to provide first-hand data for the normalization management of COVID-19 "Class B and Class B".
The so-called real-world research refers to the collection and analysis of health-related data on predetermined clinical problems in a non-human designed environment, to study the effectiveness and safety of drugs in the real world. The "Research on the Therapeutic Effect of Anti COVID-19 Drugs on COVID-19 in Chinese Medical and Health Institutions" was initiated by the China Community Health Association, and led by Professor Jiang Rongmeng of Beijing Ditan Hospital affiliated to Capital Medical University. The study focused on the real scene of COVID-19's diagnosis and treatment. Doctors timely entered data and regularly followed up COVID-19 infected people during the diagnosis and treatment process, and realized the whole course management of patients through the digital platform, accumulating more extensive evidence for the clinical application of COVID-19 drugs; Meanwhile, by analyzing the overall medical expenses of patients, we can answer which treatment model has more clinical and pharmacoeconomic advantages.
Professor Jiang Rongmeng said that there are more and more COVID-19 small molecule drugs and their clinical accessibility is getting better, but there is still a lack of large sample real world research, as well as large sample pharmacoeconomic evaluation, head to head comparative research of antiviral drugs, etc. This study will help to explore the advantages and disadvantages of anti COVID-19 drugs, and also promote medical institutions to detect and treat patients with COVID-19 at an early stage, so as to reduce the conversion of disease to severe disease.
Professor Jiang Rongmeng teaches research methods to doctors involved in real-world research.
The COVID-19 small molecule oral drugs approved for listing in China are two imported ones and four domestic ones. From the perspective of the target of action, it can be divided into two categories: one type acts on the 3CL target, mainly including Pfizer's Paxlovid, Xiansheng Pharmaceutical's Xiannuoxin, and Zhongsheng's Leruiling; Another type is RdRp inhibitors, mainly including Azvudine in real organisms, Monolavir in Mercadon, and Mindavir in Junshi Biotechnology.
Paxlovid targets the 3CL target and uses a combination of "nematevir+ritonavir" drugs. Among domestic drugs, Xiannuoxin also adopts a combination therapy of Xiannuotevir and Litonavir targeting this target. The 3CL target is highly conserved, not easily affected by viral mutations, and has high safety with no reproductive or genetic toxicity. The combination of ritonavir for antiviral treatment has a long history. Whether it is pexlovid's nematevir or sinoxin's sinovir, with the assistance of ritonavir, both drugs can delay their metabolic breakdown in the body and improve their antiviral efficacy.
Wang Chen, an academician of the CAE Member and an expert in respiratory medicine and critical care medicine, said: 3CL drugs are the mainstream among anti COVID-19 drugs. 3CL drugs combined with ritonavir therapy have been adjusted from "emergency use authorization" to official approval of the US FDA, proving the effectiveness and safety of this treatment. He believes that the domestically produced 3CL drug Xiannuoxin has outstanding characteristics in effectiveness and safety, with scientific basis and solid clinical evidence.
At present, anti COVID-19 drugs listed in China are listed according to the special drug approval procedure, with conditions attached after emergency review. Its main channel for obtaining drugs is through hospital prescriptions. Experts in the department of infectious diseases said that accelerating the post marketing research of COVID-19 drugs and making domestic COVID-19 drugs fully available without "conditionality" will help improve the accessibility of domestic affordable COVID-19 drugs for oral use, and people are expected to obtain drugs more conveniently through Internet hospitals, social pharmacies and other channels.
It is reported that on online platforms such as Taobao, JD.com, and Meituan, offline medical institutions with prescriptions for Kaixian Nuoxin, Paxlovid, and Mindewe can be booked; Search for "COVID-19 Special Medicine" or "Convenient Medicine Map", and you can get the medicine according to the guide. On the WeChat platform, search the "Xiannuoxin Drug Interaction" applet, and you can also obtain the popular science knowledge of COVID-19 disease, understand the interaction of multiple drugs, and query the nearby medical institutions with drugs.