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1.
Pediatrics ; 149, 2022.
Article in English | EMBASE | ID: covidwho-2003414

ABSTRACT

Background: Most children exposed to SARS-CoV-2 virus present with mild symptoms, but some may experience severe illnesses such as Multisystem inflammatory syndrome (MISC) or respiratory failure. Currently there are no established biomarkers to predict progression to severe disease. Although specific serum cytokines have been found to be higher in adults with severe COVID-19, their role as predictors of severe disease in children remains unclear. Further, the role of salivary cytokines in COVID-19 associated inflammation is unknown. Our objective was to compare cytokine levels in saliva of children with and without severe disease due to SARS-CoV-2 infection. Methods: This prospective observational study, conducted at two tertiary children's hospitals, was supported by a grant from the National Institute of Health RADx Program. Children ≤ 18 years of age with symptoms due to SARS-CoV-2 infection (positive PCR test, serology or immunological link) were enrolled after informed consent. Severe cases were defined as the occurrence of any of the following within 30 days of testing: diagnosis of MISC or Kawasaki disease, requirement for >2L oxygen, inotropes, mechanical ventilation or ECMO, or death. A saliva sample was obtained through passive drool using MicroSAL kits (Oasis Diagnostics) and a viral transport medium (VTM-C19, Biomed). Abundance levels of six cytokines (TNFR1, IL13, IL-15, CCL7, CXCL10 and CXCL9) were measured in triplicate using microfluidic immunoassays (Ella, Protein Simple). Mean concentrations for each sample were determined against a standard curve and corrected for dilution. Levels of the six cytokines were compared between those with severe or nonsevere SARS-CoV-2 symptoms using a non-parametric t-test. The relationship between salivary levels of individual cytokines was assessed among children with severe and non-severe SARS-CoV2 using a Pearson correlation analysis Results: A total of 150 children were enrolled from 03/29/2021 to 05/30/2021 (mean age of 7.1 years ± 5.7 years, 54.6% females). Of the total, 38 (25.3%) children met criteria for severe SARS-CoV-2 infection. CXCL10 displayed significantly (fold change>2, p < 0.05) elevated levels in the saliva of children with severe SARS-CoV-2 (Figure 1). The relationship between levels of CXCL9 (MIG) and CXCL10 showed greater levels association (R2 = 0.93) in children with severe SARS-CoV-2 than in peers with non-severe SARS-CoV-2 (R2 = 0.65;Figure 2). Conclusion: In this preliminary analysis of salivary cytokines among children with SARS-CoV-2 infection, we found CXCL10 displayed differential expression with severe symptoms. These findings may provide critical information about the pathophysiology of severe SARS-CoV-2. Confirmation in further studies is necessary. Saliva concentrations of CXCL10 in children with severe SARSCoV-2 symptoms. The whisker box plots display salivary concentrations of CXCL10 in children with severe (green) and non-severe (red) SARS-CoV-2 infection as measured with next generation enzyme linked immunosorbent assay. Levels of CXCL10 (p < 0.01;fold change = 3.04) were elevated in children with severe SARS-CoV-2 symptoms on Wilcoxon testing. .

2.
Pediatrics ; 149, 2022.
Article in English | EMBASE | ID: covidwho-2003167

ABSTRACT

Background: The majority of children with exposure to SARSCoV-2 virus have mild disease. However severe diseases such as Multisystem inflammatory syndrome (MISC) and pneumonia do occur in children. Currently, there are no established biomarkers that can predict progression to severe disease in children exposed to the virus. MicroRNAs (miRNAs) are non-coding RNAs that can be found in saliva and are thought to play a role in the regulation of inflammation following an infection. Our objective was to compare the miRNA profile in saliva of children with or without severe disease due to SARS-CoV-2 infection. Methods: This prospective observational study was supported by the National Institutes of Health (NIH) RADx Program. Children ≤ 18 years of age presenting to two tertiary care children's hospitals with symptoms of SARS-CoV-2 infection (confirmed by PCR test, serology or epidemiological link) were enrolled between 03/29/2021 and 04/30/2021. Severe infection was defined as any of the following within 30 days of testing: MISC or Kawasaki disease diagnosis, requirement for oxygen > 2L, inotropes, mechanical ventilation or ECMO, or the occurrence of death. Informed consent and a saliva swab were obtained at the time of SARS-CoV-2 diagnosis (DNA Genotek, Ottowa Canada), and RNA was extracted (Qiagen, Germantown, MD). Small RNA species (<50 base pairs) were interrogated via shotgun sequencing (HiSeq 2500, Illumina, San Diego, CA) and miRNAs were quantified through alignment to the human genome (GRCh38). RNA features with sparse counts (<10 in 90% of samples) were filtered, and the data was quantile normalized and mean-center scaled. Salivary miRNA levels were compared between those with severe and non-severe SARS-CoV-2 infection using Wilcoxon tests with Benjamini Hochberg multiple testing corrections. In addition, a logistic regression analysis was used to identify miRNA pairs that could best discriminate severe cases based on a Monte Carlo 100-fold cross-validated area under receiver operating characteristic curve (AUROC). Results: Samples from 33 children were analyzed. Median age was 3 (3, 10) years and 54.5% were males. Of the total, 29 were RT PCR positive, 4 had a positive serology and 6 children had severe infection. Seven miRNAs displayed significant differences (Fold change >2, FDR adjusted p < 0.1) among children with severe SARS-CoV-2 infection (Table). All seven miRNAs were up-regulated in severe SARS-CoV-2 cases. A logistic regression using a single ratio of miR-296-5p/miR-378j yielded 1.0 AUROC for differentiating children with severe infection (Figure). Conclusion: In this interim analysis of salivary miRNA in childhood SARS-CoV-2 infection, we found a differential expression of 7 salivary miRNAs in children with severe infection. Ongoing work will seek to validate these findings and explore the role of miRNA in predicting severe SARS-CoV-2 infection in children. Receiver operating characteristic curve and box plot displaying the complete differentiation of severe and non- severe SARSCoV-2 cases using a ratio of miR-296-5p and miR-378j levels in saliva.

3.
Pediatrics ; 149, 2022.
Article in English | EMBASE | ID: covidwho-2003108

ABSTRACT

Background: The COVID-19 pandemic has been shown to have a compounding effect on families across various social and healthcare needs. However, the impact of social determinants of health (SDOH) on COVID-19 disease severity in children is unknown. Our objectives were to describe the SDOH in children with SARS-CoV-2 infection and determine their association with severity of the infection Methods: This prospective observational study was supported by the National Institutes of Health RADx program and conducted in the emergency department (ED) of two large children's hospitals. Children ≤ 18 years of age with symptoms due to SARS-CoV-2 infection (positive RT PCR test, serology or epidemiological link) were enrolled between 03/29/2021 and 05/30/2021. Data collected from electronic medical records included demographics, clinical features, treatment, disposition, and outcomes. Severe cases were defined as the following within 30 days of test positivity: diagnosis of Multisystem inflammatory syndrome in children or Kawasaki disease, requirement for oxygen > 2L, inotropes, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or death. Following informed consent, caregivers were surveyed via an electronic device on previously validated PhenX questions. Aligned with the Healthy People 2020 SDOH framework, caregivers reported on economic stability, education, social and community context, health and health care, and neighborhood and built environment. Stata was used to analyze descriptive statistics, and unadjusted comparisons between groups were assessed using two sample t-tests for continuous variables and Fisher's exact test for categorical variables due to small sizes. Results: A total of 107 children (mean age 6.9 (±5.9) years, 44.9% males), with SARS-CoV-2 infection were enrolled, and 85 caregivers (79.4%) completed the survey (71.4% Black). In this sample, 97% of children were RT PCR positive, 3% had an epidemiological link, and 23 (27.1%) were categorized as severe. Almost half of caregivers (47.6%) reported employment or income loss due to COVID-19. The three most common SDOH needs identified were that of childcare (22.0%), housing instability (22.0%), and food insecurity (21.7%). Children with severe COVID-19 were significantly more likely to have a caregiver who was single, including never married, separated/divorced, and widowed (82.6% vs. 52.5%;Table 1). Although not statistically significant, children with severe COVID-19 tended to have higher levels of social needs including housing instability, poor caregiver mental health, and lower levels of social support compared to children with nonsevere infection (Table 2). Conclusion: Our preliminary data on SDOH suggest that among children with SARS-CoV-2 infection, housing instability, food insecurity and childcare needs are particularly prevalent. Children with severe SARS-CoV-2 infection were more likely to have single caregivers. Family structure may influence severe COVID-19 in children and programming and supports for single parent households should be considered. Larger studies in the ED setting will help confirm these findings and to direct resources to address these social needs.

4.
Journal of Urology ; 207(SUPPL 5):e425-e426, 2022.
Article in English | EMBASE | ID: covidwho-1886502

ABSTRACT

INTRODUCTION AND OBJECTIVE: During the COVID-19 pandemic, the use of both video visits (VV) and telephone visits (TV) surged. While insurance coverage for VVs has continued after the pandemic, coverage for TVs remains less certain. We sought to evaluate why patients select TVs over VVs in our academic Urology practice. METHODS: All patients who attempted to schedule telemedicine visits with our practice from 11/2020-5/2021 were first offered a VV. If the patient declined a VV and selected a TV, they were prompted to select a reason from a list. Patient and visit characteristics for both VV and TV cohorts were reviewed and these variables were compared between groups. RESULTS: 1937 patients (1180 male, 757 female) completed telemedicine visits (27% VVs, 73% TVs) between 11/2020 and 5/2021 in our practice. Patients who opted for TVs were more likely to be male (74.6% of males vs 69.9% of females, p=.02), older (84.2% of >65 years old vs 71.5% of 51-65 years old vs 58.2% of 18-50 years old, p=.03), Spanish-speaking (85.9% of Spanish-speakers vs 68.9% of English-speakers, p<.001), and returning for a follow-up visit (79.3% of follow-up patients vs 44.2% of new patients, p<.001). The population did not vary significantly by race/ethnicity or socioeconomic status. Among 1409 TV patients, 1300 (92.3%) provided reasons for preferring TV over VV. The most commonly reported reasons were limited access to smart devices (39.4%) and lack of desire for a VV (47.7%). Less frequently reported responses included language barriers (2.1%), dissatisfaction with a prior telemedicine visit (2.1%), and data/network limitations (1%). CONCLUSIONS: Within our urban, racially diverse patient population, the majority of patients preferred TVs over VVs. Limited access to video-capable smart devices was a prevalent reason. Further analysis should be conducted into understanding the reasons why certain groups of patients are significantly more likely to opt for TVs than others, including males, older patients, Spanish-speakers, and follow-up patients. Additionally, in order to improve access to care in underserved areas, congressional efforts to continue adequate reimbursement for TVs should be encouraged and further research into barriers to patients' acceptance of VVs is needed. (Table Presented).

6.
Chinese Journal of Disease Control and Prevention ; 26(2):188-192 and 217, 2022.
Article in Chinese | EMBASE | ID: covidwho-1822638

ABSTRACT

Objective To describe the social support, anxiety, and sleep quality of residents in the District of Shanghai during the COVID-19 and to analyze the to correlation of these factors. Methods A structured questionnaire was used to investigate residents' social support, anxiety, and sleep quality. The questionnaire consisted of social support rate scale, the self-rating anxiety scale (SAS) and Pittsburgh sleep quality index (PSQI), investigated the social support, anxiety, and sleep quality of residents in the District of Shanghai under the COVID-19 epidemic and analyzed their potential influencing factors. Structural equation model was constructed to understand the relationship among these factors. Results A total of 258 questionnaires were collected, with 237 being eligible for analyzing. The results showed that there were statistically significant differences in sleep quality (P =0.004) and social support (P =0.009) among residents with different highest education levels. The structural equation model-fitting indices were CFI =0.929, NFI =0.891, IFI =0.930, NNFI =0.907, RMSEA =0.082, χ 2/df =2.599. It indicated that the fitting degree was good. The results showed that the social support of residents could affect their anxiety degree to some extent (r=-0.15). The higher the social support, the lower the anxiety degree they had. Moreover, the degree of anxiety could affect the sleep quality (r =0.72), and the higher the degree of anxiety, the worse the sleep quality they had. Conclusion During the epidemic of COVID-19, residents' social support is related to their anxiety level, and the anxiety level is related to their sleep quality. By improving residents' support, their degree of anxiety could be reduced to improve their sleep quality.

7.
IEEE International Conference on Robotics and Automation (ICRA) ; : 14018-14024, 2021.
Article in English | Web of Science | ID: covidwho-1799297

ABSTRACT

Human activities are hugely restricted by COVID-19, recently. Robots that can conduct inter-floor navigation attract much public attention since they can substitute human workers to conduct the service work. However, current robots either depend on human assistance or elevator retrofitting, and fully autonomous inter-floor navigation is still not available. As the very first step of inter-floor navigation, elevator button segmentation and recognition hold an important position. Therefore, we release the first large-scale publicly available elevator panel dataset in this work, containing 3,718 panel images with 35,100 button labels, to facilitate more powerful algorithms on autonomous elevator operation. Together with the dataset, a number of deep learning based implementations for button segmentation and recognition are also released to benchmark future methods in the community. The dataset is available at https://github.com/zhudelong/elevator_button_recognition

8.
Journal of Computer Assisted Learning ; 2022.
Article in English | Scopus | ID: covidwho-1731175

ABSTRACT

Backgroud: uring the COVID-19 pandemic, online learning has played an increasingly crucial role in the educational system. Academic dishonesty (AD) in online learning is a challenging problem that represents a complex psychological and social phenomenon for learners. However, there is a lack of comprehensive and systematic reviews of AD in online learning environments. Objectives: This study presents a systematic study of AD in online learning environments to delineate its trends and uncover potential areas for further research. Methods: We conducted this review based on various sources of evidence-based research and followed the guidelines of the PRISMA statement and procedure for selection. After the exclusion criteria were employed, 59 eligible articles were selected and then analysed in a descriptive overview. Two frameworks were identified in the structured content analysis to analyse these articles. One was the framework of Gilbert's Behaviour Engineering Model (BEM), and the other was the types of interventions for online AD, where 36 articles were analysed. Results and Conclusions: The descriptive results showed that most studies used quantitative methods and focused on students. The analysis results of influencing factors under the BEM framework showed that the category of environment support and tools accounts for the largest proportion. And the types of interventions for online AD we classified include individual AD & high technological complexity, individual AD & low technological complexity, collective AD & high technological complexity, and collective AD & low technological complexity. These findings provide a comprehensive understanding and guidance of AD in the online environment for relevant managers, designers and developers. © 2022 The Authors. Journal of Computer Assisted Learning published by John Wiley & Sons Ltd.

9.
9th International Symposium of Chinese CHI: Identity, Value. Trust, Chinese CHI 2021 ; : 83-91, 2021.
Article in English | Scopus | ID: covidwho-1699133

ABSTRACT

As the COVID-19 in 2020 has increased negative emotions such as stress, anxiety and fear, many people have online counseling about psychological anxiety from counselors. However, it is easy to cause compassion fatigue for counselors with the sudden increase in consultations. Therefore, it is essential to pay attention to the compassion fatigue of counselors in epidemic counseling situations and assist counselors in regulating their state. In this study, we performed semi-structured interviews with nine counselors and focused groups with five counselor supervisors based on the context of online psychological counseling during the epidemic. The results show counselors expected compassion fatigue to be relieved by habit-forming, less physical exertion and quick emotional smoothing. Then we designed a product using gFace++' for facial recognition to achieve fatigue arousal and smart hardware to achieve meditation function. Finally, we performed the usability tests with eight counselors to optimize the design. © 2021 ACM.

10.
Medical Journal of Peking Union Medical College Hospital ; 12(1):136-140, 2021.
Article in Chinese | Scopus | ID: covidwho-1513190

ABSTRACT

Objective To investigate the impact of the outbreak of coronavirus disease 2019 (COVID-19) as an intervention factor on residency training at different stages, and look into the enhancement effect of post-graduation medical training program based on competency of residency training, so as to provide reference for the optimization of medical education at the postgraduate stage. Methods After the initial success of COVID-19 prevention and control, 169 clinical postdoctoral trainess(clinical postdocs) and 515 graduate students specializing in clinical medicine(professional postdocs) were surveyed by an anonymous online questionnaire. To analyze the differences of cognition and self- evaluation of core competence between the two groups. Results There were 141 valid questionnaires collected from clinical postdocs (83.43%, 141/169) and 264 valid questionnaires collected from professional postdocs (51.26%, 264/515). In both groups, more than 85% of the students agreed or strongly agreed that they had a deeper understanding of the profession of doctors during the epidemic. The results of competency self-evaluation showed that, except for the items of "self-improvement", the self-evaluation scores of clinical postdoctoral students on other items were significantly higher than those of professional postdoctoral students (all P <0.05). Conclusions COVID-19, as a factor of emergency intervention, can improve the competency cognition of residents. The core-competency based post-graduation medical education model can comprehensively improve the students' comprehensive ability, which is an effective training program for residents. It is suggested that the vocational planning education for residents should be paid attention to in the stage of college education, and a new mode of college education that is closely combined with the post-graduation education should be further explored. © 2021 Thomson Reuters and Contributors.

11.
13th International Conference on Intelligent Computation Technology and Automation, ICICTA 2020 ; : 310-311, 2020.
Article in English | Scopus | ID: covidwho-1480070

ABSTRACT

In this study, comprehensive experiment of pharmacy was designed as four independent and interrelated task modules based on the concept of task-driven and was completed by the virtual simulation technology on line. The students consulted the literature, designed the experiment plan and carried out the experiment on the virtual simulation experiment platform. Besides, they can also complete self-directed learning and get the scores by the help of the virtual simulation software. This technology is not only helpful for the promotion of learning initiative and practical innovative ability of students, but also can enables online learning for students with significant advantages for the prevention and control of COVID-19. © 2020 IEEE.

12.
Journal of Thoracic Oncology ; 16(10):S1022-S1023, 2021.
Article in English | EMBASE | ID: covidwho-1474809

ABSTRACT

Introduction: Background: Our phase single-arm phase 2 study previously showed favorable efficacy of sintilimab plus docetaxel as second line therapy for advanced Chinese NSCLC patients. Here we presented the updated survival and safety data. Methods: Eligible patients were standard platinum doublet failure advanced NSCLC patients, who had not received any ICIs before. EGFR/ALK positive patients must be TKIs failure or intolerable. Participants would receive docetaxel (75mg/m2, day 1) plus sintilimab (200mg, day 3) every 3 weeks for 4-6 cycles followed by sintilimab maintenance until disease progression, unacceptable toxicity, or up to 2 years. The primary end point is progression-free survival (PFS) per RECIST v1.1. Secondary end points included overall response rate (ORR), duration of response (DOR), overall survival (OS), and safety. Results: From 10/2019 to 11/2020, 40 patients were enrolled. Most were male (77.5%) and adenocarcinoma (87.5%). 25% (10/40) patients and 12.5% (5/40) had brain and liver metastasis at baseline, separately. Median follow-up was 9.0 months (range 1.6-16.2) as of data cut-off (2/19/2021). 13 patients temporarily suspended study treatment due to COVID-19, while 11 patients resumed treatment after documented progression-free. Among all, 9 patients were still on study treatment until data cut-off. Median PFS was 5.78 months (95%CI 4.3-8.28), and PFS rates at 6 months and 12 months were 47% and 23%. Median OS was 12.45 months (95%CI 5.82-12.62). 12 months OS rates was 64%. Of the 37 evaluable patients, ORR is 32.43% (95%CI 18.01%, 49.79%), DCR is 89.19% (95%CI 74.58%, 96.97%). Median DOR was 6.46 months (95% 1.28, NA). Median TTR (Time to Response) was 3.89 months (95% 1.61, 4.99). Efficacy of key subgroups are presented in Table 1. [Formula presented] Median treatment duration was 4.4 months (range 0.1-13.9). Overall, 72.5% (29/40) patients had experienced treatment-related adverse events (TRAEs), including 15% (6/40) grade ≥3 TRAEs. No AEs led to treatment discontinuation or death. The most common TRAEs were leukopenia (32.5%), neutropenia (17.5%), alopecia (12.5%), lymphopenia (7.5%), fatigue (7.5%) and diarrhea (7.5%). 27.5% (11/40) patients experienced potential immune related AEs (irAEs), including 1 grade 3 gamma-glutamyltransferase increase, 1 grade 2 hypothyroidism and 3 grade 2 pneumonitis. Conclusion: This is the first study of a PD-1 inhibitor plus chemotherapy in advanced Chinese NSCLC patients who had failed first-line standard therapy. The encouraging efficacy and tolerable safety profile suggest a potential role of this combination in second-line setting. Clinical trial information: ChiCTR1900027634. Keywords: non-small cell lung cancer, combination chemoimmunotherapy, second line

13.
10th International Conference on Design, User Experience, and Usability, DUXU 2021, held as part of the 23rd International Conference, HCI International 2021 ; 12779 LNCS:156-170, 2021.
Article in English | Scopus | ID: covidwho-1359860

ABSTRACT

Due to COVID-19 (Coronavirus Disease - 19), most schools have adopted remote or mixed methods to teach;therefore, students need new types of educational products to achieve a high-quality learning experience. There are many difficulties and obstacles to taking classes online. More interactions and formats need to be explored for students to absorb as much classroom knowledge as possible. The research team conducted a design workshop. Thirty-eight psychology and applied psychology students participated in this workshop using different user research methods, such as user journey maps and how-to methods. They explored educational products in five scenarios: taking physical education classes, giving online learning feedback, conducting teamwork, taking an online examination, and studying in the dormitory. Each group proposed design solutions to solve design problems in a particular context. For the 56 design problems, the participants identified 548 design solutions. The facilitator helped the group select six or seven design challenges with higher priorities. All the research data were collected, and the jobs-to-be-done (JTBD) theory was used to analyze users’ needs for future educational products. The users’ needs were summarized into user need clusters. This study has identified seven primary user needs and 20 sub-needs in five scenarios. The insights gained from this study may be of assistance to UX designers and UX researchers to obtain a new perspective on scenarios. © 2021, Springer Nature Switzerland AG.

14.
2020 Ieee International Conference on Bioinformatics and Biomedicine ; : 1063-1067, 2020.
Article in English | Web of Science | ID: covidwho-1354403

ABSTRACT

During the COVID-19 pandemic, there has been an emerging need for rapid, dedicated, and point-of-care COVID19 patient disposition techniques to optimize resource utilization and clinical workflow. In view of this need, we present COVIDMobileXpert: a lightweight deep neural network (DNN) based mobile app that can use chest X-ray (CXR) for COVID-19 case screening and radiological trajectory prediction. We design and implement a novel three-player knowledge transfer and distillation (KTD) framework including a pre-trained attending physician (AP) network that extracts CXR imaging features from a large scale of lung disease CXR images, a fine-tuned resident fellow (RF) network that learns the essential CXR imaging features to discriminate COVID-19 from pneumonia and/or normal cases with a small amount of COVID-19 cases, and a trained lightweight medical student (MS) network to perform on-device COVID-19 patient triage and follow-up. To tackle the challenge of vastly similar and dominant fore-and background in medical images, we employ novel loss functions and training schemes for the MS network to learn the robust features. We demonstrate the significant potential of COVID-MobileXpert for rapid deployment via extensive experiments with diverse MS architecture and tuning parameter settings.

15.
Journal of Organizational and End User Computing ; 33(6):16, 2021.
Article in English | Web of Science | ID: covidwho-1339645

ABSTRACT

The sudden attack of the new coronavirus in 2020 has brought an unprecedented impact on the real estate market economy and has completely disrupted people's work and life rhythms! With the rapid development of the internet, the internet has penetrated into all aspects of people's lives. As soon as e-commerce was introduced, it was loved by the majority of young people and brought tremendous changes to people's lives. As an important pillar industry of the national economy, real estate lacks a better e-commerce model and is still in the traditional sales model, waiting for customers to come. With the advent of the era of big data, breakthroughs in IT technology have made the collection, analysis, and processing of big data a reality, which makes it possible for big data to provide guidance for the development of e-commerce. As traditional processing technologies and ways of thinking gradually fail to meet application requirements, people have reached a consensus that big data will trigger the next revolution in the e-commerce industry, and how to make the real estate industry develop better in this revolution has become a reality. Based on this, this paper studies a real estate virtual e-commerce model based on big data. In the study of this model, this paper combines the advantages of e-commerce and virtual communities to design a more effective virtual e-commerce model that collects the data of virtual e-commerce platforms for analysis and processing, accurately obtains the needs of customers, provides customers with more reasonable options to meet their needs, and promoted the healthy development of the real estate industry. The analysis of e-commerce and virtual communities shows that the virtual e-commerce model designed in this paper is a more effective model, and the real estate virtual e-commerce model based on big data technology can serve the real estate industry and do a good job in the sales reform of the real estate industry.

16.
Chinese Medical Journal ; 28:28, 2021.
Article in English | MEDLINE | ID: covidwho-1209266

ABSTRACT

BACKGROUND: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults. METHODS: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18-59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 mug/dose or 10 mug/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 mug/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose. RESULTS: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-mug vaccine (n = 24), 10-mug vaccine (n = 24), or placebo (n = 12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-mug vaccine (n = 100 for 0/14 or 0/28 regimens), 10-mug vaccine (n = 100 for each regimen), or placebo (n = 50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and 7 (58%) participants reported at least one adverse event (AE) after receiving 5-mug vaccine, 10-mug vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and 9 (18%) 0/14-regimen participants reported at least one AE after receiving 5-mug vaccine, 10-mug vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses;0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses. CONCLUSIONS: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-mug vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial. TRIAL REGISTRATION: http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350;No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353).

17.
Open Forum Infectious Diseases ; 7(SUPPL 1):S344-S345, 2020.
Article in English | EMBASE | ID: covidwho-1185920

ABSTRACT

Background: SARS-CoV2 is a grave illness and few therapeutic agents have yielded benefit or reduced mortality. Administration of convalescent plasma (CP) in viral illnesses in the past, including SARS, before day 14, has been associated with a shorter hospital course. In the present study, we are interested in determining the benefit of administering CP to critically ill patients in the intensive care unit, and the impact on mortality and other clinical markers. Methods: 5 critically ill patients with confirmed SARS-CoV2 infection were observed in the uncontrolled case series study. Mechanically ventilated patients with severe ARDS (PaO2/FiO2 < 100) were eligible to receive CP transfusion. We reviewed daily vital signs, inflammatory markers, PaO2/FiO2 ratio and SOFA scores before and after CP transfusions. SARS-CoV2 PCR viral load testing was completed on day 0 of transfusion and repeated on day 3 and 6. Complications during the hospitalization and 30-day mortality were assessed. Results: All 5 patients were mechanically ventilated at the time of transfusion and between day 7 to 31 of their illness. Following plasma transfusion, body temperature and inflammatory markers remained elevated in four patients (figure 1). SOFA score and PaO2/FiO2 ratios continued to worsen in three and four patients respectively (figure 2). SARS-CoV2 PCR remained positive in 4 patients. 4 of the 5 patients had died at the end of the follow up period. One patient was successfully extubated on day 29 (table 1) and discharged after a long hospital course. Conclusion: In our patient cohort, the administration of CP did not improve laboratory markers or clinical outcomes. Some notable limitations of this study are the small sample size, and that the patients received CP late in their disease course. Further investigation is necessary to draw definitive conclusions about the utility of CP in the treatment of SARS-CoV2. (Table Presented).

18.
Science ; 369(6510):1505-1509, 2020.
Article in English | EMBASE | ID: covidwho-1177509

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in an unprecedented public health crisis. There are no approved vaccines or therapeutics for treating COVID-19. Here we report a humanized monoclonal antibody, H014, that efficiently neutralizes SARS-CoV-2 and SARS-CoV pseudoviruses as well as authentic SARS-CoV-2 at nanomolar concentrations by engaging the spike (S) receptor binding domain (RBD). H014 administration reduced SARS-CoV-2 titers in infected lungs and prevented pulmonary pathology in a human angiotensin-converting enzyme 2 mouse model. Cryo-electron microscopy characterization of the SARS-CoV-2 S trimer in complex with the H014 Fab fragment unveiled a previously uncharacterized conformational epitope, which was only accessible when the RBD was in an open conformation. Biochemical, cellular, virological, and structural studies demonstrated that H014 prevents attachment of SARS-CoV-2 to its host cell receptors. Epitope analysis of available neutralizing antibodies against SARS-CoV and SARS-CoV-2 uncovered broad cross-protective epitopes. Our results highlight a key role for antibody-based therapeutic interventions in the treatment of COVID-19.

19.
Circulation ; 142:2, 2020.
Article in English | Web of Science | ID: covidwho-1089370
20.
Frontiers in Cellular and Infection Microbiology ; 9 (no pagination)(463), 2020.
Article in English | EMBASE | ID: covidwho-827748

ABSTRACT

The duplicate US1 genes of duck enteritis virus (DEV) encode a protein with a conserved Herpes_IE68 domain, which was found to be closely related to the herpes virus immediate early regulatory protein family and is highly conserved among counterparts encoded by Herpes_IE68 genes. Previous studies found the homologous proteins HSV-1 ICP22 and VZV ORF63/ORF70 to be critical for virus transcription and replication. However, little is known about the DEV ICP22 protein. In this paper, we describe the characteristics of this protein based on pharmacological experiments, real-time quantitative Polymerase Chain Reaction, Western blot, and immunofluorescence assays. We also investigate the role of the protein in DEV replication via mutation of US1. As a result, we found that the DEV ICP22 protein is a non-essential immediate early protein predominantly located in the nucleus of infected DEF cells and that DEV replication is impaired by US1 deletion. We also found that ICP22 contains a classical nuclear localization signal (NLS) at 305-312AA, and ICP22 cannot enter the nucleus by itself after mutating residue 309. © Copyright © 2020 Li, Wu, Wang, Ma, Jia, Chen, Zhu, Liu, Yang, Zhao, Zhang, Huang, Ou, Mao, Zhang, Liu, Yu, Pan, Tian, Rehman, Chen and Cheng.

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