ABSTRACT
BACKGROUND: Nirmatrelvir-ritonavir has been authorized for emergency use by many countries for the treatment of coronavirus disease 2019 (Covid-19). However, the supply falls short of the global demand, which creates a need for more options. VV116 is an oral antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We conducted a phase 3, noninferiority, observer-blinded, randomized trial during the outbreak caused by the B.1.1.529 (omicron) variant of SARS-CoV-2. Symptomatic adults with mild-to-moderate Covid-19 with a high risk of progression were assigned to receive a 5-day course of either VV116 or nirmatrelvir-ritonavir. The primary end point was the time to sustained clinical recovery through day 28. Sustained clinical recovery was defined as the alleviation of all Covid-19-related target symptoms to a total score of 0 or 1 for the sum of each symptom (on a scale from 0 to 3, with higher scores indicating greater severity; total scores on the 11-item scale range from 0 to 33) for 2 consecutive days. A lower boundary of the two-sided 95% confidence interval for the hazard ratio of more than 0.8 was considered to indicate noninferiority (with a hazard ratio of >1 indicating a shorter time to sustained clinical recovery with VV116 than with nirmatrelvir-ritonavir). RESULTS: A total of 822 participants underwent randomization, and 771 received VV116 (384 participants) or nirmatrelvir-ritonavir (387 participants). The noninferiority of VV116 to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery was established in the primary analysis (hazard ratio, 1.17; 95% confidence interval [CI], 1.01 to 1.35) and was maintained in the final analysis (median, 4 days with VV116 and 5 days with nirmatrelvir-ritonavir; hazard ratio, 1.17; 95% CI, 1.02 to 1.36). In the final analysis, the time to sustained symptom resolution (score of 0 for each of the 11 Covid-19-related target symptoms for 2 consecutive days) and to a first negative SARS-CoV-2 test did not differ substantially between the two groups. No participants in either group had died or had had progression to severe Covid-19 by day 28. The incidence of adverse events was lower in the VV116 group than in the nirmatrelvir-ritonavir group (67.4% vs. 77.3%). CONCLUSIONS: Among adults with mild-to-moderate Covid-19 who were at risk for progression, VV116 was noninferior to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery, with fewer safety concerns. (Funded by Vigonvita Life Sciences and others; ClinicalTrials.gov number, NCT05341609; Chinese Clinical Trial Registry number, ChiCTR2200057856.).
Subject(s)
Antiviral Agents , COVID-19 Drug Treatment , COVID-19 , Adult , Humans , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , COVID-19/virology , COVID-19 Drug Treatment/methods , Ritonavir/administration & dosage , Ritonavir/adverse effects , Ritonavir/therapeutic use , SARS-CoV-2 , Administration, Oral , Single-Blind Method , Disease ProgressionABSTRACT
Objectives: Sleep disturbance and mental health are challenges for healthcare workers (HCWs). Especially during the COVID-19 pandemic, they experienced more severe sleep and mental health problems. However, the association between sleep disturbance and the mental health of HCWs is still controversial. This study aimed to systematically review the relationship by conducting a systematic review and meta-analysis. Method: Two researchers retrieved the literature from Web of Science, PubMed, EMBASE, CINAHL, Psyclnfo, and Cochrane Library from the establishment of the databases until November 20, 2021. We used the New Castle-Ottawa Scale (NOS) and Agency for Healthcare Research and Quality (AHRQ) to evaluate the risk of bias in prospective research and cross-sectional research, respectively. The major exposure was HCWs' sleep disturbance, and the major outcome was mental health. The correlation coefficients (r), regression coefficients (ß) and odds ratios (OR) of the included studies were integrated. Result: Fifty-nine studies were included for qualitative analysis, of which 30 studies could be combined and entered into quantitative analysis. There were 23 studies during the COVID-19 pandemic among the 59 included studies. The results of the meta-analysis showed that the correlation coefficient between sleep disturbance and mental health was 0.43 (95% CI: 0.39-0.47). HCWs with sleep disturbance had a 3.74 (95% CI: 2.76-5.07) times higher risk of mental health problems than those without sleep disturbance. The correlation coefficient during the COVID-19 epidemic was 0.45 (95% CI: 0.37-0.53), while it was 0.40 (95% CI: 0.36-0.44) during the non-epidemic period. Subgroup analysis compared the OR results in epidemic and non-epidemic periods of COVID-19, which were 4.48 (95% CI: 2.75-5.07) and 3.74 (95% CI: 2.74-7.32), respectively. Conclusion: Sleep disturbance and mental health problems were positively correlated among HCWs. Particularly in the COVID-19 pandemic, more attention should be given to this issue.
Subject(s)
Angiotensin-Converting Enzyme 2/metabolism , COVID-19/enzymology , Extracellular Vesicles/enzymology , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/metabolism , Virus Internalization , ADAM17 Protein/metabolism , COVID-19/virology , Caco-2 Cells , Dipeptidyl Peptidase 4/metabolism , Extracellular Vesicles/virology , Host-Pathogen Interactions , Humans , Membrane Proteins/metabolism , Protein Binding , Serine Endopeptidases/metabolismABSTRACT
Objective@#To investigate the current status of screen time in preschoolers during the outbreak of Corona Virus Disease 2019 (COVID-19), and the influences of parent-child active play and school online education on screen time.@*Methods@#A total of 2 370 preschoolers were chosen through clustering sampling from 7 kindergartens in Wuxi urban areas. Questionnaire survey was administered to parents for child screen time, active play, online education as well as characteristics information.@*Results@#A total of 1 428(60.3%) preschoolers reported more than 1 hour screen time a day, and 1 915(80.8%) preschoolers reported more than 20 minutes consecutive screen time. Compared with the weekend before the COVID-19 outbreak, 1 551(65.4%) preschoolers reported an increase of 10 minutes in screen time perday, and 1 444(60.9%) reported an increase of 5 minutes for one sersion. Logistic regression analysis showed that after controlling for confounding factors, high frequency of parent-child active play, parents’ exercise habits, online education from kindergartens and children’s active participation in the online education were negatively associated with preschoolers’ excessive and increased screen time during this period(OR=0.39-0.79, P<0.05).@*Conclusion@#During the COVID-19 outbreak, preschoolers’ media use in Wuxi city is worrisome. Parent-child active play, parents’ exercise and online education from kindergartens may play a positive role in reducing preschoolers’ media use.
ABSTRACT
通过对浙江大学医学院附属第一医院急诊科筛查出的 4 例新型冠状病毒肺炎 (新冠肺炎) 病例进行分析, 探讨急诊科在新冠肺炎精准筛查和诊断中的作用。 分析新型冠状病毒肺炎的致病机制、 传播方式和临床特征;总结急诊科医护人员的自身防护和诊断策略. 回顾性分析我院急诊科筛查出的 4 例新型冠状病毒肺炎病例, 总结急诊科的临床价值. 在新冠肺炎的筛查和诊断体系中, 中国急诊科发挥了不可替代的作用. 急诊科医护人员应充分做好自身防护, 对患者进行细致、 耐心、 谨慎地病史采集和全面的体格检查, 并关注患者的心理状态, 有效应用肺部计算机断层扫描 (CT)、 核酸检测等检测方法, 做好新冠肺炎筛查工作.