Source investigation of a COVID-19 outbreak in the sea-land border city

Objective: To analyze the epidemiological characteristic and tracing process of an outbreak of COVID-19 in a sea-land border city (D city) of Guangxi in December 2021, and provide scientific data for for the emergency management and scientific traceability of similar outbreaks in the future. Methods Epidemiological investigation of cases was carried out under the guideline of the Novel Coronavirus Epidemiological Investigation Programme on Cases of Pneumonia (Edition 8). RT-PCR method was used for samples testing. Furthermore, positive samples were analyzed by whole-genome sequence and phylogenetic analysis. R software 4.1.3 version was used for data analysis. Results There were 20 cases in this outbreak which related 6 families. The average incubation period was (4.6..2.2) d. Compared with the Wuhan reference strain (NC_045512), the genome sequence analysis showed that there were 35-36 nucleotide mutation sites in the novel Coronavirus genome sequence of 19 local cases, which belonged to VOC/Delta variant strain (AY.57 evolutionary branch). The 11 amino acid mutation sites were the same in all the novel Coronavirus spikes (S) proteins, which were highly homologous to the 2 COVID-19 genome sequences uploaded from a neighboring country in the GISAID genome database. Conclusion This outbreak was caused by fishermen who were infected by contacting with persons of neighboring country in the public sea area and causing located community transmission. The management of border villagers and the monitoring of epidemic strains should be strengthened to detect and deal with the outbreak as early as possible in the future.

Mental distress, quality of life and physical symptoms in Chinese women with ovarian cancer receiving olaparib treatment during the COVID-19 pandemic.

Objectives: Women with ovarian cancer (OC) have experienced unprecedented challenges since the novel coronavirus disease-2019 (COVID-19) outbreak in China. We aim to evaluate the experience of psychological status, physical symptoms and quality of life (QoL) and investigate the impact of COVID-19 pandemic on OC patients receiving olaparib. Methods: The survey was conducted online from April 22 to May 12 in 2020. Demographic and clinical questions were listed to collect general information. The degree of insomnia, depression, anxiety, stress symptoms and QoL were assessed by the Chinese versions of the Insomnia Severity Index, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, the Impact of Event Scale-Revised, and the General Functional Assessment of Cancer Therapy, respectively. Multivariate logistic regression analysis was conducted to analyze the risk factors for mental distress and QoL. Results: A total of 56 respondents coming from 15 various provinces in China participated in the survey. The prevalence of insomnia, depressive, anxiety, stress symptoms and reduced QoL were 37.5, 51.8, 37.5, 30.4, and 51.8%, respectively. Unfavorable disease status, shorter period of olaparib administration, adverse events of olaparib and delay in cancer care were correlated with mental health problems. Reduced QoL was also significantly associated with psychological distress. Conclusions: This study emphasized that mental health problems and reduced QoL should gain more attention in women with OC who are receiving oral olaparib at home. Appropriate psychological healthcare strategies are necessary for OC patients during the COVID-19 pandemic.

Mental distress, quality of life and physical symptoms in Chinese women with ovarian cancer receiving olaparib treatment during the COVID-19 pandemic

Objectives Women with ovarian cancer (OC) have experienced unprecedented challenges since the novel coronavirus disease-2019 (COVID-19) outbreak in China. We aim to evaluate the experience of psychological status, physical symptoms and quality of life (QoL) and investigate the impact of COVID-19 pandemic on OC patients receiving olaparib. Methods The survey was conducted online from April 22 to May 12 in 2020. Demographic and clinical questions were listed to collect general information. The degree of insomnia, depression, anxiety, stress symptoms and QoL were assessed by the Chinese versions of the Insomnia Severity Index, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, the Impact of Event Scale-Revised, and the General Functional Assessment of Cancer Therapy, respectively. Multivariate logistic regression analysis was conducted to analyze the risk factors for mental distress and QoL. Results A total of 56 respondents coming from 15 various provinces in China participated in the survey. The prevalence of insomnia, depressive, anxiety, stress symptoms and reduced QoL were 37.5, 51.8, 37.5, 30.4, and 51.8%, respectively. Unfavorable disease status, shorter period of olaparib administration, adverse events of olaparib and delay in cancer care were correlated with mental health problems. Reduced QoL was also significantly associated with psychological distress. Conclusions This study emphasized that mental health problems and reduced QoL should gain more attention in women with OC who are receiving oral olaparib at home. Appropriate psychological healthcare strategies are necessary for OC patients during the COVID-19 pandemic.

Traditional Chinese medicine treatment for COVID-19: An overview of systematic reviews and meta-analyses.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has caused an extensive burden to the world. Consequently, a large number of clinical trials have examined the efficacy of traditional Chinese medicine (TCM) for treating and preventing COVID-19, with coinciding proliferation of reviews summarizing these studies. OBJECTIVE: This study aimed to evaluate the methodological quality and evidence quality of systematic reviews and meta-analyses on the efficacy of TCM. SEARCH STRATEGY: Seven electronic databases, including PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data and SinoMed, were searched for systematic reviews and meta-analyses in October 2021. Search terms such as "Chinese medicine," "Lianhua Qingwen" and "COVID-19" were used. INCLUSION CRITERIA: Systematic reviews and meta-analyses of randomized controlled trials that evaluated the efficacy of TCM treatment of COVID-19 were included. DATA EXTRACTION AND ANALYSIS: A Measurement Tool to Assess Systematic Reviews Version 2.0 (AMSTAR 2) was used to evaluate the methodological quality. The quality of evidence was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Data extraction and analysis were performed by two reviewers independently. RESULTS: There were 17 meta-analyses included in our overview. The intervention group was defined as TCM combined with Western medicine, while the control group was Western medicine alone. The methodological quality of all the included studies was moderate to poor. A total of 89 outcome indicators were evaluated, of which, 8 were rated as moderate quality, 39 as low quality, and 41 as very low quality. Only one outcome measure was graded as being of high quality. The moderate quality of evidence indicated that, for the treatment of COVID-19, the clinical efficacy of TCM in combination with Western medicine was better, in terms of lung recovery, rate of conversion to severe/critical cases, symptom scores, duration of symptoms, mortality, and length of hospital stay. CONCLUSION: Evidence from the included studies shows that, compared with conventional Western medical therapy alone, the addition of TCM to COVID-19 treatment may improve clinical outcomes. Overall, the quality of evidence of TCM for COVID-19 was moderate to poor. Meta-analyses of the use of TCM in the treatment of COVID-19 can be used for clinical decision making by accounting for the experiences of clinical experts, medical policies, and other factors.

Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov.

BACKGROUND AND OBJECTIVE: The novel coronavirus disease (COVID-19) outbreak is currently ravaging populations worldwide. Many studies were registered and conducted in rapid response to the epidemic, but how to choose the proper design for clinical trials remains the main concern. This study aimed to determine the fundamental characteristics of study design during the COVID-19 pandemic and provide references for other emerging infectious diseases. METHODS: We searched the database of ClinicalTrials.gov with the keyword "COVID-19" and compared the results with the design features of other conventional studies except for COVID-19. RESULTS: From January 1, 2020 to September 30, 2021, 55,334 trials were registered at ClinicalTrials.gov. Of all the registered trials, 6,408 were related to COVID-19 (11.58%). There were significant differences in the proportion of observational studies between COVID-19 (43.48%) and others (23.27%). The completion rate of observational trials and interventional trials in COVID-19 was 29.04% and 25.84%, respectively. COVID-19 trials showed a higher rate of completion than others (P<0.01). The time distribution and trend of observational studies and interventional studies varied considerably. CONCLUSION: Appropriately designed trials can help to improve research efficiency and reduce the possibility of research failure. In addition to randomized controlled trials, observational and single-armed studies are also worth considering.

Efficacy and Safety of Chinese Medicine for COVID-19: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of traditional Chinese medicine for COVID-19 treatment with a focus on the benefits of symptomatic relief and time-related indexes. Seven electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data, and Chinese Clinical Trial Registry) were systematically searched from their beginning to April 2021. Only randomized controlled trials (RCTs) comparing patients using Western therapy (WT) alone and those using additional Chinese medicine (WT [Formula: see text] CM) were included. Primary outcomes included overall efficacy, lung recovery, and time to viral assay conversion. Secondary outcomes included time and rate of individual symptom recovery, laboratory indicators, and adverse events. Overall, 15 RCTs, including 1469 participants, were included in this review. WT [Formula: see text] CM significantly improved overall efficacy (risk ratio, RR [Formula: see text] 1.21; 95% CI: 1.12 to 1.30; [Formula: see text] [Formula: see text] 0.01) and lung recovery (RR [Formula: see text] 1.30; 95% CI:1.19 to 1.42; [Formula: see text] [Formula: see text] 0.01) and shortened the time to viral assay conversion (weighted mean differences, WMD [Formula: see text]1.38; 95% CI: -1.98 to -0.78; [Formula: see text] [Formula: see text] 0.01) and duration of chest distress (WMD [Formula: see text] 2.41; 95% CI: -2.99 to -1.83; [Formula: see text] [Formula: see text] 0.01) compared to WT alone. There was no difference in safety between the WT [Formula: see text] CM and WT groups (RR [Formula: see text] 0.94; 95% CI: 0.64 to 1.39; [Formula: see text] 0.76). In conclusion, the synthesized evidence from 15 RCTs showed that additional Chinese medication may improve treatment efficacy, relieve symptoms, promote lung recovery, and reduce the inflammatory response against COVID-19, while not increasing the risk of adverse events compared with conventional Western medication alone.

Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov

Background and Objective The outbreak of the novel coronavirus disease (COVID-19) is currently ravaging worldwide. A large number of studies were registered and conducted in rapid response to the epidemic, but how to choose the proper design for clinical trials still remains the main concern. This study aimed to determine fundamental characteristics of study design during the COVID-19 epidemic and provide references for other emerging infectious diseases. Methods We searched the database of ClinicalTrials.gov with the keyword 'COVID-19′ and compared them with the design features of other conventional studies except for COVID-19. Results From January 1, 2020 to September 30, 2021, 55 334 trials were registered at ClinicalTrials.gov. Of all the registered trials, 6408 were related to COVID-19(11.58%). There were significant differences in the proportion of observational studies between COVID-19 (43.48%) and others (23.27%). The completion rate of observational trials and interventional trials in COVID-19 was 29.04% and 25.84%, respectively. COVID-19 trials showed a higher rate of completion than others (P<0.01). The time distribution and trend of observational studies and interventional studies varied considerably. Conclusion Appropriately designed trials can help to improve research efficiency and reduce the possibility of research failure. In addition to randomized controlled trials, observational and single-armed studies are also worth considering.

The efficacy assessment of convalescent plasma therapy for COVID-19 patients: a multi-center case series.

Convalescent plasma (CP) transfusion has been indicated as a promising therapy in the treatment for other emerging viral infections. However, the quality control of CP and individual variation in patients in different studies make it rather difficult to evaluate the efficacy and risk of CP therapy for coronavirus disease 2019 (COVID-19). We aimed to explore the potential efficacy of CP therapy, and to assess the possible factors associated with its efficacy. We enrolled eight critical or severe COVID-19 patients from four centers. Each patient was transfused with 200-400 mL of CP from seven recovered donors. The primary indicators for clinical efficacy assessment were the changes of clinical symptoms, laboratory parameters, and radiological image after CP transfusion. CP donors had a wide range of antibody levels measured by serology tests which were to some degree correlated with the neutralizing antibody (NAb) level. No adverse events were observed during and after CP transfusion. Following CP transfusion, six out of eight patients showed improved oxygen support status; chest CT indicated varying degrees of absorption of pulmonary lesions in six patients within 8 days; the viral load was decreased to a negative level in five patients who had the previous viremia; other laboratory parameters also tended to improve, including increased lymphocyte counts, decreased C-reactive protein, procalcitonin, and indicators for liver function. The clinical efficacy might be associated with CP transfusion time, transfused dose, and the NAb levels of CP. This study indicated that CP might be a potential therapy for severe patients with COVID-19.

LEGITIMATE EXPECTATIONS IN A TIME OF PANDEMIC: THE HOST STATE'S COVID-19 MEASURES, ITS OBLIGATIONS AND POSSIBLE DEFENSES UNDER INTERNATIONAL INVESTMENT AGREEMENTS

The unprecedented COVID-19 pandemic has drastically changed the world we live in, and exerted negative impacts on business activities, including international trade and investments. In order to flatten the rocketing curve of confirmed COVID-19 cases, countries have implemented preventive measures such as restricting international travel, suspending almost all kinds of businesses, and even nationalizing certain products (e.g., masks) from private enterprises. While the purpose of these government actions is legitimate and reasonable namely to protect public health these profound and unprecedented measures will adversely affect both domestic and foreign companies' managements and businesses. Under the protection of the international investment agreement (hereinafter "IIA"), the affected foreign investor is entitled to initiate the investment claim, asserting that the regulatory environment of the host state has been changed, or arguing that the host state is in breach of the commitments which have been made and constituted the foundation for the investments. And the host state might therefore be claimed to have failed to provide the fair and equitable treatment (hereinafter "FET") required by the HA. The tension between the host state's COVID-19 measures and the foreign investors' legitimate expectations hence arises. This article focuses on the legitimacy of host states' COVID-19 measures and examines whether those measures, though creating regulatory changes in host states, impede foreign investors' legitimate expectations and constitute a violation of FET under the HA. Insomuch that the COVID-19 crisis seems to be unpredictable, this article argues that the protection of foreign investors' legitimate expectations should not be unlimited, and the preventive measures implemented by host states should be respected, providing that the normative changes are in bona fide nature and proportionate. In addition, this article also proposes certain public health defenses which are available for host states to justify their COVID-19 measures and which should be considered by the arbitral tribunals. In short, it is hoped that the findings and analysis of this article can offer a different angle to understand the scope of the foreign investors' legitimate expectations and more broadly, host states' FET obligation in a time of pandemic.