Today, the world's top authoritative medical journal "New England Journal of Medicine" (NEJM) published online the oral nucleoside anti-new coronavirus drug VV116 (JT001) compared with nematvir tablets/ritona The results of the Phase III registration clinical study (NCT05341609) of the PAXLOVID combination drug for the early treatment of patients with mild to moderate novel coronavirus pneumonia (Covid-19) who are at high risk of progression to severe disease including death. The results of
showed that the primary endpoint of the study reached non-inferiority. Compared with PAXLOVID, showed that patients receiving VV116 treatment performed equally or even better in promoting recovery. The clinical recovery time of the VV116 group was shorter and the safety performance was better.
This study was led by Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Zhao Ren, deputy director of Ruijin Hospital in charge of the designated hospital of Ruijin North Hospital, is the corresponding author. It is the first "head-to-head" phase III clinical study of small molecule oral antiviral drugs for Chinese COVID-19 patients during the epidemic of the Omicron variant strain.
This research is an important scientific research result completed during the Battle of Shanghai in the first half of this year. When facing the epidemic in March this year, Ruijin Hospital not only completed the conversion of designated hospitals and the admission of -positive -infected patients within 48 hours, but also sent 21 medical teams to participate in the treatment of designated hospitals and makeshift cabins, and completed multiple tasks such as nucleic acid detection and . In addition, during the busy clinical treatment period, it went all out to complete the Phase III non-inferiority observer-blinded randomized controlled clinical trial of VV116 with 822 people enrolled, while maintaining quality and quantity.
It is almost an impossible task to complete large-scale clinical research efficiently and quickly, but the scientific research team of Ruijin Hospital has achieved it, which is inseparable from the standardized scientific research management of Ruijin Hospital. Ruijin Hospital has always attached great importance to translational research that starts from clinical problems, solves them through scientific research, and then returns to clinical practice to benefit patients. Especially after the Translational Medicine National Major Science and Technology Infrastructure (Shanghai) was put into trial operation in 2019, this 54,000-square-meter center with 300 research beds has built six major platforms, namely a standardized clinical biobank, an in-depth clinical resource analysis and mining platform, a biomarker and drug R&D and new drug creation platform, a diagnostic reagent and instrument development platform, a molecular pathology and imaging technology research platform, and a clinical research ward, focusing on the national innovation strategy and the Healthy China Strategy. It has successfully built a clinical research and platform operation system. Based on the construction of the Translational Medicine Center,
has also formed a close and integrated open and cooperative mechanism with scientific research institutions, research institutes, biomedical companies, etc. At the same time, an excellent and efficient research team has been cultivated.
In the early days of the 2020 COVID-19 outbreak, the Center for Translational Medicine undertook a large number of COVID-19 research tasks and achieved a series of results. For example, in March 2020, the research team of the Center for Translational Medicine took the lead in organizing 16 hospitals across the country to conduct a randomized controlled study and confirmed that for patients with mild and moderate COVID-19, hydroxychloroquine cannot significantly shorten the time for the virus to turn negative, and there is no significant improvement in patient symptom relief. This research result has had a huge impact on the global fight against the epidemic and prompted many countries to revise their COVID-19 treatment plans to avoid the potential harm caused by a large number of incorrect medication. The research results were published in "BMJ".
At the same time, the sequencing platform team of the Center for Translational Medicine cooperated with the Shanghai Public Health Center to sequence, assemble, and analyze the novel coronavirus genome on samples from patients infected with the novel coronavirus in the Shanghai area. By integrating virus evolution information and clinical data, discovered the determinants of the severity of COVID-19 disease development. This study clarified the key early warning factors for the transition of the disease to severe disease, and the research results were published in Nature.
"In addition, focusing on the problem of asymptomatic infection of the new coronavirus, the sequencing platform team of the Center for Translational Medicine, in cooperation with the Shanghai Public Health Center, revealed for the first time the main immunological characteristics of persistent asymptomatic infections and latent asymptomatic infections. provides a theoretical basis for early identification of asymptomatic infections in the latent period in clinical work, and timely intervention at an earlier stage to block their progress for confirmed patients. The research results were published in the form of a cover paper in "Cell" research". "Xu Yiping, Director of the Scientific Research Department of Ruijin Hospital, is very knowledgeable.
After this round of actual combat, the clinical research level of the Center for Translational Medicine and the detection capabilities of the platform have been further improved, further consolidating the close cooperation and transformation model between clinical and basic.
During this year's Great Shanghai Defense War, in addition to clinical research on VV116, the Transformation Center Sequencing Platform research team also cooperated with the Shanghai Public Health Center and multiple makeshift hospitals to confirm the dynamic evolution process of the prevalent strains in Shanghai, dominated by the Omicron variant Ba.2.2.1, and to analyze the molecular mechanism of the high infectivity of the Omicron mutant strain. At the same time, revealed that the viruses in environmental samples with positive nucleic acid tests were all genomic nucleic acid fragments, providing a strong scientific basis for optimizing environmental disinfection strategies and formulating national epidemic prevention priorities. research results were published in "Lancet" and "Cell Discovery" respectively.
The Ruijin research team conducted an in-depth analysis of the whole-genome sequencing data of 10,000 people from the China Metabolic Analysis Project (ChinaMAP), identified various known or unidentified viral sequences contained in the blood of the population, revealed the first Chinese population blood viromics map, and analyzed 14 The population carrying rate, virus abundance and geographical distribution of this widespread virus can provide important basis for virus infection prevention, vaccine development and viral genome, epidemiology, and other research. The research results were published in "Cell Discovery".
Clinical research, as the name suggests, in addition to research, there must also be clinical treatment. The comprehensive strength of Ruijin Hospital shows its unique advantages.
"In addition to the designated hospitals in northern Ruijin and the major shelters in charge of operation and management of Ruijin Hospital, the new coronavirus patients enrolled in the group have also received strong support from many designated hospitals and shelters in Shanghai." Zhao Ren, deputy director of Ruijin Hospital, said that the fever clinic of Ruijin General Hospital was the first standardized fever clinic built in Shanghai in the early days of the epidemic that complied with the "six no-go out" management requirements. At the same time, The fever clinic has a built-in nucleic acid testing P2 laboratory, which can complete rapid nucleic acid testing within 40 minutes; the virus laboratory of Ruijin Hospital can carry out new coronavirus PCR testing, with an average daily testing capacity of 15,000 tubes. is based on the strong clinical reception and laboratory testing capabilities of the fever clinic and virus laboratory of Ruijin Hospital, which has played an active role in the smooth enrollment of VV116 clinical trial subjects.
Ensuring patient safety is also an important requirement in clinical research. "In the clinical trials of VV116, the enrollment targets are mainly adult patients with mild to moderate Covid-19 who are symptomatic and have a high risk of progression. Most of these patients have underlying diseases. After being infected with the new coronavirus, their underlying diseases are at risk of further aggravation. After taking VV116 or control drugs at the same time, there may also be a certain incidence of adverse drug reactions. All these require clinical close attention to changes in the patient's condition and active and effective treatment." said Gao Weiyi, director of the medical department of Ruijin Hospital.
benefits from the strong multi-disciplinary diagnosis and treatment team and clinical diagnosis and treatment capabilities of Ruijin Hospital. Ruijin Hospital has deployed multi-level diagnosis and treatment teams in designated hospitals, including hospital expert groups and multi-disciplinary clinical diagnosis and treatment teams, responsible for the clinical observation and treatment of subjects in clinical trials to ensure medical safety. The expert group is led by Qu Jieming, chairman of the Respiratory Disease Branch of the Chinese Medical Association and secretary of the Party Committee of Ruijin Hospital, and uses remote dialogue and bedside consultation visualization systems to guide the treatment of critically ill patients with COVID-19.The multidisciplinary diagnosis and treatment team is composed of clinical medicine, nursing, nutrition, psychology and other multidisciplinary medical teams. It takes into account the physical care and humanistic care of the test subjects, helping them to smoothly survive the physiological discomfort during the infection period, while relieving anxiety, and cooperating throughout the entire clinical trial process to successfully complete the clinical trial process.
Efficient combat is inseparable from an efficient emergency command system. During the Great Shanghai Defense War, Ruijin Hospital undertook the arduous tasks of multi-point and multi-line operations such as normal medical care, makeshift shelters and designated hospitals, as well as many important scientific research tasks, all of which were inseparable from the hospital's efficient command system. Academician Ning Guang, the president of Ruijin Hospital, led the command. The team has been stationed at the hospital's operation and management command center for more than three consecutive months, coordinating and allocating all medical resources such as personnel, materials, equipment, and space throughout the hospital during the day; scientific research discussions are held as scheduled every night, and the VV116 clinical trial progress is posted online at 8 o'clock every night.
“It is because of the hard work of all our colleagues that we can successfully complete this study.” Ning Guang, academician of the Chinese Academy of Engineering and president of Ruijin Hospital, said, “Today, the results of this study published in the New England Journal of Medicine confirm that the clinical efficacy of VV116 is no less than that of PAXLOVID Thank you to the entire team for their hard work and selfless dedication day and night. Now that China’s epidemic policy has changed and the country is about to open, our research not only provides valuable data and experience for the development and clinical application of global anti-COVID-19 small molecule drugs, but will also contribute to China’s anti-epidemic cause.”
Author: Tang Wenjia. Zhu Fan
Editor: Tang Wenjia
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