Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 33
Filter
1.
17th Annual ACM/IEEE International Conference on Human-Robot Interaction, HRI 2022 ; JOUR:870-874, 2022-March.
Article in English | Scopus | ID: covidwho-2097606

ABSTRACT

The use of social robots has recently been investigated in various areas, including STEM (Science, Technology, Engineering, and Mathematics) education and artistic performances. To inform children of the seriousness of climate change and awareness that they can make change, we created the Robot Musical Theater performance. In this project, natural elements (wind, earth, fire, and water) were anthropomorphized and represented by humanoid robots (Pepper, Milo, and Nao). The robots were designed to motivate audience to participate in the action to prevent climate change. Because of COVID, only fourteen visitors as a single group were allowed to participate in real-time and posted to YouTube, where at the time of submission, 141 people have viewed the performance. The participants provided positive comments on the performance and showed their willingness to participate in the movement to prevent climate change, and expressed their further interest in STEM learning. This performance is expected to contribute to enhancing informal STEM and robotics learning, as well as advancing robotic arts. © 2022 IEEE.

2.
Xitong Gongcheng Lilun yu Shijian/System Engineering Theory and Practice ; 42(8):2017-2036, 2022.
Article in Chinese | Scopus | ID: covidwho-2056375

ABSTRACT

Faced with the double shock of COVID-19 and Sino-US trade conflict, how to upgrade technology and products and then establish a "dual circulation" development pattern has become the major challenges for Chinese government and enterprises. Under the framework of heterogeneous enterprise theory, this paper introduces foreign ownership structure into enterprise skill demand function, and discusses the influence of foreign ownership structure on the skill upgrade of export enterprises and domestic enterprises. And this paper make empirical verification for the model deductions, based on the data of industrial enterprise from 2000 to 2008. The results confirm that:1) The skilled wage of export enterprises are always higher than that of domestic enterprises based on the same proportion of foreign capital;2) The skilled wage of domestic-sale and export firms will increase with higher proportion of foreign capital, but the characteristics of the latter only holds for foreign-ownership enterprises;3) Once the proportion of foreign exceed 0.5, it will induce a dramatic change for corporate culture, and thus impulse the skilled wage jump up into a higher level which is more prominent among exporters. It is showed that continuing to expand the level of opening to the outside world, lifting control on foreign capital, strengthening the cooperation between domestic and foreign capital can more effectively promote the technology promotion and skill upgrading of Chinese enterprises, and jointly accelerate the establishment of an expanding domestic market and a leading trade power. © 2022 Systems Engineering Society of China. All rights reserved.

3.
Drug Evaluation Research ; 45(8):1517-1521, 2022.
Article in Japanese | Scopus | ID: covidwho-2025328

ABSTRACT

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation. © 2022 by the Author(s).

4.
2022 IEEE International Conference on Artificial Intelligence and Computer Applications, ICAICA 2022 ; : 724-729, 2022.
Article in English | Scopus | ID: covidwho-2018779

ABSTRACT

With the development of modern technology and the rise of artificial intelligence, the application scenarios of identity authentication technology are becoming more and more complex, especially in the current situation of the spread of the new coronavirus, traditional identity authentication technology can no longer meet people's practical needs, and society urgently needs a security and convenient authentication technology. Voiceprint recognition is a kind of biometric technology, and it is one of the products of comprehensive research on computer technology, acoustics and life sciences. This paper introduces a voiceprint recognition check-in system based on deep learning algorithm. In this design, the audio is converted into Mel frequency cepstral coefficients, and then the convolution network is provided to extract features. Finally, the similarity is calculated to obtain the classification result for voiceprint feature extraction, which is compared with the voice database data to realize voiceprint recognition. The voiceprint recognition check-in system introduced in this paper has a check-in system with an interactive interface. The average recognition rate of the system measured by experiments is higher than 93.3%, which can meet the requirements of practical applications. © 2022 IEEE.

5.
Frontiers in Public Health ; 10:876883, 2022.
Article in English | MEDLINE | ID: covidwho-1974687

ABSTRACT

Objectives: The overall objective of this proposed project is to examine the impact of the COVID-19 pandemic on the mental health, functioning and wellbeing of medical laboratory technologists (MLT) and medical laboratory technicians/assistants (MLT/A) in Ontario, Canada. Methods: A cross-sectional study included a self-reported questionnaire for MLT and MLT/A in Ontario. The questionnaire included questions about demographics and occupational characteristics. Questions about mental health, functioning, well-being and psychosocial work environments were also included using validated questionnaires. Results: There were 551 MLT and 401 MLT/A in the analytic sample. Most of the respondents were women. The mean age and standard deviation of the overall sample were 42.0 +/- 11.8. MLT demonstrated higher quantitative demands, possibilities for development, and organizational justice compared to MLT/A. The scores of work pace, emotional demands, role conflicts, job insecurity, insecurity over working conditions and negative acts were higher for MLT/A than MLT. The WHODAS 2.0 scores of the respondents were 20.80 +/- 6.68, higher than approximately 92% average people. For both groups, most respondents scored the COPSOQ-III domains as worse since COVID-19. Conclusion: The study provides preliminary evidence regarding the workplace mental health outcomes of medical laboratory professionals in Ontario, Canada. The findings suggest that MLT and MLT/A experience psychosocial work conditions that impact mental health, functioning and disability. Accordingly, additional research is necessary to understand the experiences of medical laboratory professionals.

6.
Chinese Journal of Digestive Surgery ; 19(7):703-713, 2020.
Article in Chinese | Scopus | ID: covidwho-1934281
7.
Quantitative Biology ; 9(1):23-46, 2021.
Article in English | ProQuest Central | ID: covidwho-1876231

ABSTRACT

COVID-19 is now rapidly spreading worldwide. While the majority of COVID-19 patients show only mild or moderate symptoms, some could deteriorate quickly and may succumb to a sudden death. It is therefore important to identify who will be more likely to develop severe outcomes and be treated with particular or preventive care. Here in this literature survey, we collected epidemiologic and clinical data from 36 articles on 51,270 patients with different severity of COVID-19, aiming to characterize the population that are prone to severe condition and bad outcomes. These data reveal that old males and those with high BMI or underlying diseases, especially cardiovascular disease, hypertension and diabetes, are overrepresented among severe cases. High leukocyte and lymphopenia are common features in severe and critical patients. Upon deterioration of the disease, both CD4 and CD8 T cells are decreased, while almost all serum cytokines, especially pro-inflammatory cytokines, increased.

8.
Journal of Investigative Medicine ; 70(4):1011-1013, 2022.
Article in English | EMBASE | ID: covidwho-1868745

ABSTRACT

Purpose of Study Children's WIC coverage rates nationally and in Connecticut (CT) have gradually decreased over the decades and substantially trail behind Infants' and Pregnant/Postpartum Women's coverage rates. The COVID-19 pandemic compounded this issue;SNAP and Medicaid enrollments increased while WIC enrollments continued to lag. Under these conditions, childhood food insecurity and nutritionrelated health disparities persist. More information is needed to identify risk factors and reasons for caregiver nonparticipation in WIC to inform potential family-centered interventions to decrease attrition. Methods Used This is a single-center cross-sectional survey study. Inclusion criteria were caregivers of WIC-eligible children who are recipients of Medicaid and present to an urban pediatric emergency department in Hartford, CT. Questions focused on caregivers' sociodemographic characteristics and attitudes, knowledge and experiences related to the WIC program. Data were analyzed using exploratory methods and logistic regression, p-values <0.05 considered significant. Summary of Results 288 caregivers met inclusion criteria. Many sociodemographic factors were similar between participants and nonparticipants (table 1). However, an association existed between nonparticipation (NP) and gender, number of adults in a household and presence of healthcare provider- dispensed education on health benefits of WIC. The risk of NP for male compared to female caregivers was 1.6, 95% CI (1.1, 2.0), p=0.02. For caregivers in two-adult households compared to one-adult households the risk of NP was 1.5, 95% CI (1.1, 2.0), p=0.02. The risk of NP for caregivers lacking compared to possessing healthcare provider- sourced education on health benefits of WIC was 1.7, 95% CI (1.3, 2.0), p<<0.01. Nonparticipating caregivers reported not needing WIC services, not knowing how to apply and being ineligible. Caregivers also disclosed barriers related to WIC appointment/clinic availability and accessibility (table 2). Conclusions Risk factors for WIC nonparticipation by caregivers of WIC-eligible children include identifying as male, living in a two-adult household and lacking healthcare providersourced education on health benefits of WIC. This suggests that clinical interventions during primary care visits, with attention to two-adult households and males with WIC-eligible children, may be a key step to decreasing WIC attrition. Further qualitative research is needed to fully grasp nonparticipating caregivers' attitudes towards WIC. (Table Presented).

9.
Embase; 2022.
Preprint in English | EMBASE | ID: ppcovidwho-337568

ABSTRACT

Background: Blended learning mode has been widely applied in medical education, especially during the current COVID-19 pandemic. This study is to evaluate the effectiveness of blended learning mode in periodontal education for further promotion . Methods: The blended learning mode consists of face-to-face classes and SPOCs built on the Xfaike online course platform. The preparation before the courses included the optimization of teaching calendar, establishment of online learning platform, integration of the online and offline content. The feedback was evaluated by a questionnaire involving instruction method, instruction content and learning outcomes. Results: All of the participants (n=65) answered the questionnaire. According to the questionnaire, the blended learning mode has been approved by all of the students. More than 95% of students convinced that blended learning mode can improve their self-learning ability. About 84.62% of students could finish the preview and review task of online courses. All of the students believed that they can exchange their questions with teachers more pertinently in offline classes after online learning, and online learning videos can be viewed smoothly and repeatedly at any time. Conclusions: The blended learning mode has been highly accepted among students, as the learning platform could provide abundant learning materials, improve self-learning ability, and provide a deeper understanding of knowledge. Thus, the blended learning could be considered as a promising educational mode for medical students to meet higher educational requirements.

10.
Chinese Journal of Biologicals ; 34(5):560-565, 2021.
Article in Chinese | EMBASE | ID: covidwho-1857139

ABSTRACT

Objective To evaluate the specificity of three consecutive batches of 2019-nCoV nucleic acid detection kit (fluorescence PCR) manufactured by Shanghai GeneoDx Biotech Co., LTD. Methods A total of 55 common respiratory pathogens, including endemic human coronaviruses (HKU1, OC43, NL63 and 229E), severe acute respiratory syndrome conronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS), seasonal influenza virus, rhinovirus, adenovirus, Klebsiella pneumonia and Mycobacterium tuberculosis, were grouped and used for verification of cross reactivity of the detection kit. According to the requirements in the Key Points of Technical Review for Registration of 2019 New Coronavirus Nucleic Acid Detection Reagents issued by Center for Medical Device Evaluation, National Medical Products Administration (NMPA), human mucoprotein, human blood, phenylephrine, oxymetazoline, sodium chloride (including those as preservatives) and other 29 interfering substances were selected to verify the anti-interference substances of this kit. Results In the verification for cross reactivity, the test results of mixed positive samples by the three consecutive batches of kit were positive, while those of negative samples were negative, indicating a coincidence rate of accuracy of 100%. The cross-reactive substances showed no effect on the test result by the kit. All the test results of positive and borderline positive samples were positive, while those of negative samples were negative, indicating a coincidence rate of accuracy of 100%. All the 29 kinds of endogenous / exogenous interfering substances showed no influence on the test results by this kit. Conclusion Hie new coronavirus 2019-nCoV nucleic acid detection kit (fluo¬rescence PCR method) manufactured by Shanghai GeneoDx Biotech Co., LTD. showed no cross-reactivity with 55 common respiratory pathogens, while showed anti-interference properties against endogenous and exogenous interfering substances such as host tissue, common respiratory pathogen and common drugs for respiratory diseases in clinic. The specificity test result of the kit met the requirements for registration of 2019 new coronavirus nucleic acid detection reagents. The test results of three consecutive batches of kits were highly stable.

11.
Zhonghua Yu Fang Yi Xue Za Zhi ; 56(3): 355-359, 2022 Mar 06.
Article in Chinese | MEDLINE | ID: covidwho-1776391

ABSTRACT

This study aimed to explore the application value of new biological specimen oral fluid in SARS-CoV-2 nucleic acid and antibody detection. Oral fluid and paired respiratory and blood specimens from 7 confirmed cases of two COVID-19 cluster epidemic were collected in Beijing from October to November 2021. SARS-CoV-2 virus and IgG antibody were detected by real time PCR kits and serum antibody detection reagents, and SARS-CoV-2 IgG antibody in oral fluids was detected by a new established method of magnetic particle chemiluminescence. The results showed that the nucleic acid amplification test of SARS-CoV-2 on nasopharyngeal swabs, throat swabs and oral fluid specimens from 3 confirmed cases of COVID-19 was positive, among which the Ct value for ORF1a/b and N gene of oral fluid samples in 2 cases was close to that of throat swab, and the Ct value of oral fluid sample for 1 case was higher than that of throat swab. The complete genome sequence of one oral fluid specimen was obtained, which belonged to the VOC/Delta variant strain. The SARS-CoV-2 IgG antibodies of the paired oral fluid and serum were all positive, and the S/CO values of oral fluid were all lower than those of serum. The series of oral fluid results showed that SARS-CoV-2 IgG antibody level increased from 11 to 32 days after the onset of the disease.


Subject(s)
COVID-19 , Nucleic Acids , COVID-19/diagnosis , Humans , SARS-CoV-2 , Sensitivity and Specificity
12.
Aerosol and Air Quality Research ; 22(4):17, 2022.
Article in English | Web of Science | ID: covidwho-1761002

ABSTRACT

The recognition that the spread of COVID-19 is primarily through airborne transmission has brought renewed urgency to understand the spread of aerosols generated from patients. Viral-laden aerosols generated from oral coughs have been well studied;however, aerosols generated from nasal sneezing has been overlooked. This scenario arises from patients who suffer allergenic rhinosinusitis, or the nasal cavity is irritated, particularly during naso-endoscopy. Nasal sneezing is characterised by an explosive blast of air exiting the nostrils, which can be considered as dual jets, resulting in the spread of viral-laden aerosols remaining suspended in the air. This study used computational fluid dynamics consisting of a hybrid RANS-LES turbulence method to model the airflow and the discrete phase model to track aerosol dispersion during nasal sneezing. The results demonstrated that the exhaled airflow jets during nasal sneezing resemble the flow characteristics of two parallel jets in co-flow. These two jets interfere with each other in the merging zone, and after they merge, the sneeze plume expands radially. The nasal sneeze forms a V-shaped plume with smaller particles in the core region. At the end of the sneeze, when the exhaled jets have lost their initial momentum, the large particle dispersion is dominated by gravity. We detected the presence of a 'sneeze puff' that transport droplets away from the body, similar to the buoyant puff observed in recent COVID-19 studies of oral coughs.

13.
Open Forum Infectious Diseases ; 8(SUPPL 1):S360-S361, 2021.
Article in English | EMBASE | ID: covidwho-1746479

ABSTRACT

Background. Enpatoran, formerly known as M5049, is a potential first-in-class small molecule antagonist of toll-like receptors (TLR) 7 and 8, which may prevent viral-associated hyperinflammatory response and progression to 'cytokine storm' in coronavirus disease 2019 (COVID-19) patients. The objective of this study was to leverage existing population pharmacokinetic/pharmacodynamic (popPK/PD) models for enpatoran to inform dose selection for an accelerated Phase II study in COVID-19 patients with pneumonia. Methods. The popPK/PD models were based on plasma PK and PD biomarker (ex vivo-stimulated interleukin [IL]6 and interferon α [IFNα] secretion) data from the enpatoran first-in-human Phase I study in healthy participants (Port A, et al. Lupus Sci Med 2020;7(Suppl. 1): P135). A two-compartment model describing PK used a sigmoidal Emax model with proportional decrease from baseline characterizing the PD response across the investigated single and multiple daily dose range of 1-200 mg (N=72). Concentrations that inhibited 50% and 90% (IC50/IC90) of cytokine secretion were estimated and stochastic simulations were performed to assess target coverage under different dosing regimens. Results. Simulations suggested that, to achieve maximal inhibition of IL-6 over time, enpatoran PK concentrations would be maintained above the IC90 throughout the dosing interval with doses of 100 mg and 50 mg twice daily in 90% and 30% of participants, respectively. In comparison, IFNα inhibition was predicted to be lower, with IC90 coverage in 60% and 8% of participants with twice daily doses of 100 mg and 50 mg enpatoran, respectively. Conclusion. Utilization of existing popPK/PD models allowed for the accelerated development of enpatoran in COVID-19 to address an unprecedented global pandemic. Rational model-informed dose selection was supported by data from a Phase I study in which there were no safety concerns.

14.
Laser Physics Letters ; 19(4):8, 2022.
Article in English | Web of Science | ID: covidwho-1713537

ABSTRACT

Viral sensitivity to high temperature and ultraviolet (UV) irradiation has been extensively studied. However, there is still little attention paid to study the joint effect of these two physical factors. Since the outbreak of the COVID-19 pandemic has necessitated the advances of disinfection techniques, rapid and effective viral inactivation by combining heat and UV light is worth investigating. This work focuses on developing such a device combining UV light-emitting diode light sources and a heater. Moreover, two UV bands have been studied in this work, namely 280 nm ultraviolet-C (UVC) and 365 nm ultraviolet-A (UVA. A) control system is developed to accurately control both the heating temperature of the device and the irradiance of the dual-spectral UV light sources. The performance of the device is verified by a series of experimental measurements. More importantly, the disinfection effect of the device has been verified by the experiments based on non-pathogenic carrier virus commonly used in the laboratory. The disinfection doses of the 280 nm UVC and 365 nm UVA light sources under the high temperature synergy have been examined. The experimental results show that when combined with a heating temperature of 60 C-circle, the cumulative UV radiation doses required for sufficient viral inactivation can be greatly reduced.

15.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-326847

ABSTRACT

The ongoing pandemic of coronavirus disease 2019 (COVID-19), which results from the rapid spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a significant global public health threat, with molecular mechanisms underlying its pathogenesis largely unknown. Small non-coding RNAs (sncRNAs) are known to play important roles in almost all biological processes. In the context of viral infections, sncRNAs have been shown to regulate the host responses, viral replication, and host-virus interaction. Compared with other subfamilies of sncRNAs, including microRNAs (miRNAs) and Piwi-interacting RNAs (piRNAs), tRNA-derived RNA fragments (tRFs) are relatively new and emerge as a significant regulator of host-virus interactions. Using T4 PNK-RNA-seq, a modified next-generation sequencing (NGS), we recently found that nasopharyngeal swabs (NPS) samples from SARS-CoV-2 positive and negative subjects show a significant difference in sncRNA profiles. There are about 166 SARS-CoV-2-impacted sncRNAs. Among them, tRFs are the most significantly affected and almost all impacted tRFs are derived from the 5'-end of tRNAs (tRF5). Using a modified qRT-PCR, which was recently developed to specifically quantify tRF5s by isolating the tRF signals from its corresponding parent tRNA signals, we validated that tRF5s derived from tRNA GluCTC (tRF5-GluCTC), LysCTT (tRF5-LysCTT), ValCAC (tRF5-ValCAC), CysGCA (tRF5-CysGCA) and GlnCTG (tRF5-GlnCTG) are enhanced in NPS samples of SARS-CoV2 patients and SARS-CoV2-infected airway epithelial cells. In addition to host-derived ncRNAs, we also identified several sncRNAs derived from the virus (svRNAs), among which a svRNA derived from CoV2 genomic site 346 to 382 (sv-CoV2-346) has the highest expression. The induction of both tRFs and sv-CoV2-346 has not been reported previously, as the lack of the 3'-OH ends of these sncRNAs prevents them to be detected by routine NGS. In summary, our studies demonstrated the involvement of tRFs in COVID-19 and revealed new CoV2 svRNAs.

16.
5th International Conference on Automation, Control and Robots, ICACR 2021 ; : 1-6, 2021.
Article in English | Scopus | ID: covidwho-1672694

ABSTRACT

The novel coronavirus has broken out from 2019 and quickly become a global pandemic. It spreads rapidly from person to person through droplets, aerosols and other carriers. In order to prevent the spread of the virus, people must wear masks when entering and leaving public places and taking public transport to reduce the risk of virus transmission. How to detect the wearing of masks in public places and other natural environments has become a new research problem. This paper proposes a lightweight deep neural network (E-YOLO) to realize mask wearing detection in real-time scenarios. E-YOLO improves the general target detection YOLOv3 algorithm by the follows methods. Firstly, the Efficient-Net series B2 backbone feature extraction network is used to replace the original Darknet53 feature extraction network. Combined with the spatial pyramid pooling module and the bidirectional feature pyramid structure to enrich the semantic information of the feature layer, so as to achieve the balance between the speed and accuracy of target detection in real-time scenes. The experimental results show that, compared with the YOLOv3 algorithm, the E-YOLO algorithm possesses the same accuracy and speed. The network floating point calculation amount is one twelfth of YOLOv3, and the model size is only one quarter of YOLOv3, which is more suitable for resource-constrained platforms. © 2021 IEEE.

17.
He Jishu/Nuclear Techniques ; 45(1), 2022.
Article in Chinese | Scopus | ID: covidwho-1631788

ABSTRACT

Irradiation technology has been widely used in the field of food processing. It is urgent to figure out whether the quality of frozen meat food would change after irradiation, when the SARS-CoV-2 was detected in the imported cold-chain meat. The effects of irradiation on the quality of frozen meat are summarized from the aspects of food sensory, protein decomposition, fat oxidation, vitamin content and so on, providing reference for the formulation of irradiation for the elimination of SARS-CoV-2 and other viruses on frozen food, as well as the study of irradiated frozen meat and the industrial development of irradiated frozen food. © 2022, Science Press. All right reserved.

18.
Traditional Medicine and Modern Medicine ; 3(4):255-268, 2020.
Article in English | EMBASE | ID: covidwho-1582962

ABSTRACT

Glucocorticoids (GCs) have potential anti-inflammatory and immunosuppressive effects. There is plenty of controversy about the application of glucocorticoids in the treatment of coronavirus disease 2019 (COVID-19). This paper briefly summarizes the mechanism of glucocorticoids and their receptors and clinical applications in COVID-19. Through reviewing the current literature, our aim is to have a deeper understanding of the mechanism of GCs and their clinical applications, so as to find possible ways to enhance their efficacy and reduce drug resistance or side effects.

19.
Traditional Medicine and Modern Medicine ; 3(1):1-9, 2020.
Article in English | EMBASE | ID: covidwho-1582960

ABSTRACT

Based on the naming of diseases in the history and the nomenclature of diseases, especially that of novel human infectious diseases, in traditional Chinese medicine (TCM) and modern medicine, we put forward the following suggestions for the naming and severity classification of "coronavirus disease 2019 (COVID-19)": (1) Patients with only nucleic acids positive or nucleic acid positive as well as some of the symptoms but without any evidence of pneumonia should be diagnosed more generally such as "Novel coronavirus respiratory infection (NCRI)"or "Novel coronavirus infection (NCI)". (2) The manifestations concerning pneumonia can be used as the main basis for the classification of the severity of the disease. For instance, those with only nucleic acids positive or nucleic acid positive as well as mild symptoms are mild, those with nucleic acid positive as well as symptoms like fever and cough are moderate, those with nucleic acid positive as well as pneumonia are severe, those with severe symptoms as well as respiratory failure and multiple organ damage are critical. (3) Also, those with infections and clinical manifestations but no pneumonia can be called simple type, and those with pneumonia can be called pneumonia type. (4) Under the current background of integrative medicine, the naming of newly emerging infectious diseases by TCM should be changed from an ambiguous concept to a clearly defined one. It may define the disease according to the etiology, pathogenesis, clinical manifestation or prognosis of the disease, redefine the original concept in TCM and discard the excessively broad part, or carry out the common naming between TCM and modern medicine based on the specific pathogen. (5) According to the nomenclature of diseases in TCM plus that in modern medicine, the NCI may be named "Jihai (2019) - Pestilence"(Ji Hài (2019) - Yì Lì) in TCM.

20.
Blood ; 138:739, 2021.
Article in English | EMBASE | ID: covidwho-1582364

ABSTRACT

Background: High-risk LBCL is associated with poor prognosis after first-line anti-CD20 mAb-containing regimens, highlighting the need for novel treatments. Axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, is approved for treatment of relapsed/refractory (R/R) LBCL after ≥2 lines of systemic therapy. Here we report the primary analysis of ZUMA-12, a Phase 2, multicenter, single-arm study of axi-cel as part of first-line therapy in patients with high-risk LBCL. Methods: Eligible adults had high-risk LBCL, defined by histology (double- or triple-hit status [MYC and BCL2 and/or BCL6 translocations] per investigator) or an IPI score ≥3, plus a positive interim PET per Lugano Classification (Deauville score [DS] 4/5) after 2 cycles of an anti-CD20 mAb and anthracycline-containing regimen. Patients underwent leukapheresis and received conditioning chemotherapy (cyclophosphamide and fludarabine) followed by a single axi-cel infusion at 2×10 6 CAR T cells/kg. Non-chemotherapy bridging could be administered before conditioning per investigator discretion. The primary endpoint was investigator-assessed complete response (CR) rate per Lugano. Secondary endpoints included objective response rate (ORR;CR + partial response), duration of response (DOR), event-free survival (EFS), progression-free survival (PFS), overall survival (OS), incidence of adverse events (AEs), and levels of CAR T cells in blood and cytokines in serum. The primary analysis occurred after all treated patients had ≥6 months of follow-up. Results: As of May 17, 2021, 42 patients were enrolled and 40 were treated with axi-cel. Median age was 61 years (range, 23-86);68% of patients were male, 63% had ECOG 1, 95% had stage III/IV disease, 48% had DS4, 53% had DS5, 25% had double- or triple-hit status per central assessment, and 78% had IPI score ≥3. A total of 37 patients had centrally confirmed double- or triple-hit histology or an IPI score ≥3 and were evaluable for response, with 15.9 months of median follow-up (range, 6.0-26.7). The CR rate was 78% (n=29;95% CI, 62-90);89% of patients had an objective response, and median time to initial response was 1 month. Among all 40 treated patients, 90% had an objective response (80% CR rate). At data cutoff, 73% of response-evaluable patients had ongoing responses. Medians for DOR, EFS, and PFS were not reached;12-month estimates were 81%, 73%, and 75%, respectively. The estimated OS at 12 months was 91%. All 40 treated patients had AEs of any grade;85% of patients had Grade ≥3 AEs, most commonly cytopenias (68%). Grade ≥3 cytokine release syndrome (CRS) and neurologic events (NEs) occurred in 3 patients (8%) and 9 patients (23%), respectively. Median times to onset of CRS and NEs were 4 days (range, 1-10) and 9 days (range, 2-44), with median durations of 6 days and 7 days, respectively. All CRS and most NEs (28/29) of any grade resolved by data cutoff (1 ongoing Grade 1 tremor);39/40 CRS events resolved by 14 days post-infusion and 19/29 NEs resolved by 21 days post-infusion. Tocilizumab was administered to 63% and 3% of patients for management of CRS or NEs, respectively;corticosteroids were administered to 35% and 33% of patients for CRS and NE management. One Grade 5 event of COVID-19 occurred (Day 350). Median peak CAR T-cell level in all treated patients was 36 cells/µL (range, 7-560), and median expansion by AUC 0-28 was 495 cells/µL × days (range, 74-4288). CAR T-cell levels peaked at a median of 8 days post-infusion (range, 8-37). Higher frequency of CCR7+CD45RA+ T cells in axi-cel product, previously associated with greater expansion of CAR T cells (Locke et al. Blood Adv. 2020), was observed in ZUMA-12, compared with the ZUMA-1 study in R/R LBCL (Neelapu et al. New Engl J Med. 2017). Conclusion: In the primary analysis of ZUMA-12, axi-cel demonstrated a high rate of rapid and complete responses in patients with high-risk LBCL, a population with high unmet need. With 15.9 months of median follow-up, responses were durable as medians for DOR, EFS, nd PFS were not yet reached and over 70% of patients remained in response at data cutoff. No new safety signals were reported with axi-cel in an earlier line. Overall, axi-cel may benefit patients exposed to fewer prior therapies, and further trials in first-line high-risk LBCL are warranted to assess axi-cel in this setting. [Formula presented] Disclosures: Neelapu: Kite, a Gilead Company, Merck, Bristol Myers Squibb, Novartis, Celgene, Pfizer, Allogene, Kuur, Incyte, Precision BioSciences, Legend, Adicet Bio, Calibr, and Unum Therapeutics: Other: personal fees;Kite, a Gilead Company, Bristol Myers Squibb, Merck, Poseida, Cellectis, Celgene, Karus Therapeutics, Unum Therapeutics (Cogent Biosciences), Allogene, Precision BioSciences, Acerta and Adicet Bio: Research Funding;Takeda Pharmaceuticals and related to cell therapy: Patents & Royalties;Kite, a Gilead Company, Merck, Bristol Myers Squibb, Novartis, Celgene, Pfizer, Allogene Therapeutics, Cell Medica/Kuur, Incyte, Precision Biosciences, Legend Biotech, Adicet Bio, Calibr, Unum Therapeutics and Bluebird Bio: Honoraria. Dickinson: Janssen: Consultancy, Honoraria;Takeda: Research Funding;Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau;Amgen: Honoraria;Celgene: Research Funding;Bristol-Myers Squibb: Consultancy, Honoraria;MSD: Consultancy, Honoraria, Research Funding, Speakers Bureau;Roche: Consultancy, Honoraria, Other: travel, accommodation, expenses, Research Funding, Speakers Bureau;Gilead Sciences: Consultancy, Honoraria, Speakers Bureau. Munoz: Kite, a Gilead Company, Kyowa, Bayer, Pharmacyclics/Janssen, Seagen, Acrotech/Aurobindo, Beigene, Verastem, AstraZeneca, Celgene/BMS, Genentech/Roche.: Speakers Bureau;Bayer, Gilead/Kite Pharma, Celgene, Merck, Portola, Incyte, Genentech, Pharmacyclics, Seattle Genetics, Janssen, and Millennium: Research Funding;Pharmacyclics/Abbvie, Bayer, Kite, a Gilead Company, Pfizer, Janssen, Juno/Celgene, Bristol Myers Squibb, Kyowa Kirin, Alexion, Fosun Kite, Innovent, Seagen, BeiGene, Debiopharm, Epizyme, Karyopharm, ADC Therapeutics, Servier, and Genmab: Consultancy, Other: advisory role;Alexion, AstraZeneca Rare Disease: Other: Study investigator;Targeted Oncology, OncView, Kyowa Kirin, Physicians' Education Resource, and Seagen: Honoraria. Thieblemont: Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Gilead Sciences: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees;Kyte: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Bristol Myers Squibb/Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees;Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding;Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees;Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Cellectis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses;Hospira: Research Funding;Bayer: Honoraria;Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses. Oluwole: Pfizer: Consultancy;Curio Science: Consultancy;Janssen: Consultancy;Kite, a Gilead Company: Consultancy, Research Funding. Herrera: Takeda: Consultancy;Genentech: Consultancy, Research Funding;Merck: Consultancy, Research Funding;Seagen: Consultancy, Research Fundi g;AstraZeneca: Consultancy, Research Funding;Kite, a Gilead Company: Research Funding;Gilead Sciences: Research Funding;Tubulis: Consultancy;ADC Therapeutics: Consultancy, Research Funding;Bristol Myers Squibb: Consultancy, Research Funding;Karyopharm: Consultancy. Ujjani: Loxo: Research Funding;AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Epizyme: Consultancy, Membership on an entity's Board of Directors or advisory committees;Janssen: Consultancy;TG Therapeutics: Honoraria;Gilead: Honoraria;ACDT: Honoraria;Kite, a Gilead Company: Honoraria;Adaptive Biotechnologies: Research Funding;Atara Bio: Consultancy;AbbVie: Consultancy, Research Funding;Pharmacyclics: Consultancy, Research Funding. Lin: Sorrento: Consultancy;Legend: Consultancy;Novartis: Consultancy;Bluebird Bio: Consultancy, Research Funding;Gamida Cell: Consultancy;Janssen: Consultancy, Research Funding;Celgene: Consultancy, Research Funding;Juno: Consultancy;Vineti: Consultancy;Takeda: Research Funding;Merck: Research Funding;Kite, a Gilead Company: Consultancy, Research Funding. Riedell: Bayer: Honoraria;Karyopharm Therapeutics: Consultancy, Honoraria;Morphosys: Research Funding;Celgene/Bristol-Myers Squibb Company: Consultancy, Honoraria, Research Funding;Verastem Oncology: Honoraria;Kite, a Gilead Company: Honoraria, Research Funding, Speakers Bureau;Novartis: Consultancy, Honoraria, Research Funding;Takeda: Consultancy;BeiGene: Consultancy;Calibr: Research Funding;Xencor: Research Funding;Tessa Therapeutics: Research Funding. Kekre: Gilead: Consultancy, Honoraria;Novartis: Consultancy, Honoraria;Celgene: Consultancy, Honoraria. Lui: Gilead Sciences: Other: stock or other ownership;Kite, a Gilead Company: Current Employment, Other: travel support. Milletti: Kite, aGilead company: Current Employment;Gilead Sciences: Other: stock or other ownership. Dong: Kite, a Gilead Company: Current Employment;Gilead Sciences: Other: stock or other ownership;GliaCure/Tufts: Consultancy, Other: advisory role, Patents & Royalties. Xu: Kite, A Gilead Company: Current Employment;Gilead Sciences: Other: stock or other ownership. Chavez: MorphoSys, Bayer, Karyopharm, Kite, a Gilead Company, Novartis, Janssen, AbbVie, TeneoBio, and Pfizer: Consultancy;ADC Therapeutics: Consultancy, Research Funding;Merk: Research Funding;AstraZeneca: Research Funding;MorphoSys, AstraZeneca, BeiGene, Genentech, Kite, a Gilead Company, and Epizyme: Speakers Bureau;BMS: Speakers Bureau.

SELECTION OF CITATIONS
SEARCH DETAIL