ABSTRACT
At present, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is spreading around the world, and the number of deaths is rapidly rising. More and more studies show that the progression of critically ill patients is closely related to the occurrence of cytokine storm. This review summarizes the concepts and mechanisms of coronavirus disease-2019 (COVID-19)-related cytokine storm, early warning, clinical manifestations, laboratory test indicators, as well as drugs and therapies with clinical application evidence or potential application prospects, in order to reduce COVID-19 patients to turning into critically ill ones and the mortality rate, and to provide evidence for early diagnosis and treatment of cytokine storm. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved.
ABSTRACT
Since the outbreak of pneumonia caused by severe acute vespiratory syndrome coronavirus 2. December 2019, the situation of epidemic prevention and control has become more serious. In order to strengthen the prevention and control of the epidemic and effectively prevent the spread, provinces and cities across the country have successively initiated grade I responses to major public health events. A large number of clinical trials have been obliged to suspend follow-up and group joining. Drug management is an important part of drug clinical trials. In order to actively respond to national requirements, clinical trial institutions around the country have launched a series of emergency management measures to respond to the administration of follow-up drug delivery in an epidemic situation and ensure safety of relevant researchers and participants. We hereby discuss the formulation of a central pharmacy management system for clinical trial institutions, with a view to safeguard the rights and interests of participants and ensure carrying out clinical trials safely, orderly and successfully.
ABSTRACT
Objective: In order to understand the current status of the work of clinical-trial-related units, strengthen communication between units, analyze relevant impact factors, and predict development trends of good clinical practice (GCP) field in the future based on the severe epidemic situation. Methods: Combined with key work in the GCP field, a questionnaire was compiled to widely understand the value of clinical trial staffs in response to outbreaks, the status of clinical trials, and their outlook for development. Statistical analysis performed after feedback was collected. Results: A total of 357 valid questionnaires were recovered. 53.45% of clinical trial institutions released response rules within 3 days, and only 5.17% of clinical trial institutions have not released relevant response measures so far. E-mail acceptance methods of research institutions accounted for 52.02%, suspended reviews of ethics committees accounted for 50.62%, and online conference reviews accounted for 22.36%. The main methods of follow-up of the subjects: telephone follow-up 35.16%, delayed follow-up 21.8%, off-site follow-up 16.03%. Off-site subjects who cannot come to the hospital and need to send medicine accounted for 50.62% and delayed drug administration for 28.88%. Different sponsors, contract research organization (CRO), site management organization (SMO) companies have taken proactive measures, such as formulating detailed drug delivery processes based on project characteristics, and remote monitoring by clinical research associate (CRA). 86.27% of employees still have great confidence in the future development of the GCP field. Conclusion: The epidemic has affected the current work of the GCP industry to varying degrees, but most units have adopted active and effective measures to maximize the health and safety of participants in clinical trials, and they still have strong confidence in the work status and development of units in GCP field after the epidemic.
ABSTRACT
At the beginning of 2020, due to the serious infection caused by severe acute respiratory syndrome coronavious 2 (SARS-CoV-2), and the prevention and control situation was grim, most provinces, cities and regions in the country have successively announced the launch of first level response to major public health emergencies. Under such cirumstance, how to standardize and efficiently manage the clinical research coordinator (CRC) under the first level response to major health emergencies is an urgent problem to be solved by the drug clinical trial institutions. In this paper, based on the general situation of drug clinical trial institutions'management of CRC in hospital, compared with the difference of management of CRC in hospital under first-level response, the key points of management were proposed, in order to provide a reference for the smooth an orderly drug clinical trials in special period.