Lipase Elevation in Patients With COVID-19.

INTRODUCTION: Although coronavirus disease (COVID-19) has been associated with gastrointestinal manifestations, its effect on the pancreas remains unclear. We aimed to assess the frequency and characteristics of hyperlipasemia in patients with COVID-19. METHODS: A retrospective cohort study of hospitalized patients across 6 US centers with COVID-19. RESULTS: Of 71 patients, 9 (12.1%) developed hyperlipasemia, with 2 (2.8%) greater than 3 times upper limit of normal. No patient developed acute pancreatitis. Hyperlipasemia was not associated with poor outcomes or symptoms. DISCUSSION: Although a mild elevation in serum lipase was observed in some patients with COVID-19, clinical acute pancreatitis was not seen.

Room-temperature-storable chemiluminescence freeze-drying mixes for detection of SARS-CoV-2 neutralizing antibody

As the vaccine was successfully developed, the spread of the epidemic (COVID-19) was effectively controlled. But there are still thousands of people affected COVID-19 after being vaccinated. Neutralizing activity has become a critical method for quantifying neutralizing antibody against SARS-CoV-2. However, limited to the strict conditions of cold chain transportation, the neutralizing activity test has not been widely promoted. In this study, a room-temperature-storable chemiluminescence freeze-drying mixes for SARS-CoV-2 neutralizing antibody detection was developed to decrease the cost of lyophilization step for promoting its application in third world countries. Several freeze concentrated solutions were used to protect the antigen bioactivity. The mixes can be stored at room temperature over 12 months and still exhibited great accuracy and precision. Thus, the proposed room-temperature-storable chemiluminescence freeze-drying mixes offers a cheap and stable storage method for SARS-CoV-2 neutralizing antibody detection and shows a great potential for promoting the neutralizing activity test.

Long COVID: The latest manifestations, mechanisms, and potential therapeutic interventions.

COVID-19 caused by SARS-CoV-2 infection affects humans not only during the acute phase of the infection, but also several weeks to 2 years after the recovery. SARS-CoV-2 infects a variety of cells in the human body, including lung cells, intestinal cells, vascular endothelial cells, olfactory epithelial cells, etc. The damages caused by the infections of these cells and enduring immune response are the basis of long COVID. Notably, the changes in gene expression caused by viral infection can also indirectly contribute to long COVID. We summarized the occurrences of both common and uncommon long COVID, including damages to lung and respiratory system, olfactory and taste deficiency, damages to myocardial, renal, muscle, and enduring inflammation. Moreover, we provided potential treatments for long COVID symptoms manifested in different organs and systems, which were based on the pathogenesis and the associations between symptoms in different organs. Importantly, we compared the differences in symptoms and frequency of long COVID caused by breakthrough infection after vaccination and infection with different variants of concern, in order to provide a comprehensive understanding of the characteristics of long COVID and propose improvement for tackling COVID-19.

Access to health care among racialised immigrants to Canada in later life: a theoretical and empirical synthesis

Evidence that immigrants tend to be underserved by the health-care system in the hosting country is well documented. While the impacts of im/migration on health-care utilisation patterns have been addressed to some extent in the existing literature, the conventional approach tends to homogenise the experience of racialised and White immigrants, and the intersecting power axes of racialisation, immigration and old age have been largely overlooked. This paper aims to consolidate three macro theories of health/behaviours, including Bronfenbrenner's ecological theory, the World Health Organization's paradigm of social determinants of health and Andersen's Behavioral Model of Health Service Use, to develop and validate an integrated multilevel framework of health-care access tailored for racialised older immigrants. Guided by this framework, a narrative review of 35 Canadian studies was conducted. Findings reveal that racial minority immigrants’ vulnerability in accessing health services are intrinsically linked to a complex interplay between racial-nativity status with numerous markers of power differences. These multilevel parameters range from socio-economic challenges, cross-cultural differences, labour and capital adequacy in the health sector, organisational accessibility and sensitivity, inter-sectoral policies, to societal values and ideology as forms of oppression. This review suggests that, counteracting a prevailing discourse of personal and cultural barriers to care, the multilevel framework is useful to inform upstream structural solutions to address power imbalances and to empower racialised immigrants in later life.

Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.

OBJECTIVE: To evaluate sintilimab versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) as first line treatment of unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. DESIGN: Multicentre, randomised, double blind, phase 3 trial. SETTING: 66 sites in China and 13 sites outside of China between 14 December 2018 and 9 April 2021. PARTICIPANTS: 659 adults (aged ≥18 years) with advanced or metastatic oesophageal squamous cell carcinoma who had not received systemic treatment. INTERVENTION: Participants were randomised 1:1 to receive sintilimab or placebo (3 mg/kg in patients weighing <60 kg or 200 mg in patients weighing ≥60 kg) in combination with cisplatin 75 mg/m2 plus paclitaxel 175 mg/m2 every three weeks. The trial was amended to allow investigators to choose the chemotherapy regimen: cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil (800 mg/m2 continuous infusion on days 1-5). MAIN OUTCOME MEASURES: Overall survival in all patients and in patients with combined positive scores of ≥10 for expression of programmed cell death ligand 1. RESULTS: 659 patients were randomly assigned to sintilimab (n=327) or placebo (n=332) with chemotherapy. 616 of 659 patients (93%) received sintilimab or placebo in combination with cisplatin plus paclitaxel and 43 of 659 patients (7%) received sintilimab or placebo in combination with cisplatin plus 5-fluorouracil. At the interim analysis, sintilimab with chemotherapy showed better overall survival compared with placebo and chemotherapy in all patients (median 16.7 v 12.5 months, hazard ratio 0.63, 95% confidence interval 0.51 to 0.78, P<0.001) and in patients with combined positive scores of ≥10 (17.2 v 13.6 months, 0.64, 0.48 to 0.85, P=0.002). Sintilimab and chemotherapy significantly improved progression free survival compared with placebo and chemotherapy in all patients (7.2 v 5.7 months, 0.56, 0.46 to 0.68, P<0.001) and in patients with combined positive scores of ≥10 (8.3 v 6.4 months, 0.58, 0.45 to 0.75, P<0.001). Adverse events related to treatment occurred in 321 of 327 patients (98%) in the sintilimab-chemotherapy group versus 326 of 332 (98%) patients in the placebo-chemotherapy group. Rates of adverse events related to treatment, grade ≥3, were 60% (196/327) and 55% (181/332) in the sintilimab-chemotherapy and placebo-chemotherapy groups, respectively. CONCLUSIONS: Compared with placebo, sintilimab in combination with cisplatin plus paclitaxel showed significant benefits in overall survival and progression free survival as first line treatment in patients with advanced or metastatic oesophageal squamous cell carcinoma. Similar benefits of sintilimab with cisplatin plus 5-fluorouracil seem promising. TRIAL REGISTRATION: ClinicalTrials.gov NCT03748134.

How Do Presenting Symptoms and Outcomes Differ by Race/Ethnicity Among Hospitalized Patients With Coronavirus Disease 2019 Infection? Experience in Massachusetts.

BACKGROUND: Population-based literature suggests severe acute respiratory syndrome coronavirus 2 infection may disproportionately affect racial/ethnic minorities; however, patient-level observations of hospitalization outcomes by race/ethnicity are limited. Our aim in this study was to characterize coronavirus disease 2019 (COVID-19)-associated morbidity and in-hospital mortality by race/ethnicity. METHODS: This was a retrospective analysis of 9 Massachusetts hospitals including all consecutive adult patients hospitalized with laboratory-confirmed COVID-19. Measured outcomes were assessed and compared by patient-reported race/ethnicity, classified as white, black, Latinx, Asian, or other. Student t test, Fischer exact test, and multivariable regression analyses were performed. RESULTS: A total of 379 patients (aged 62.9 ± 16.5 years; 55.7% men) with confirmed COVID-19 were included (49.9% white, 13.7% black, 29.8% Latinx, 3.7% Asian), of which 376 (99.2%) were insured (34.3% private, 41.2% public, 23.8% public with supplement). Latinx patients were younger, had fewer cardiopulmonary disorders, were more likely to be obese, more frequently reported fever and myalgia, and had lower D-dimer levels compared with white patients (P < .05). On multivariable analysis controlling for age, gender, obesity, cardiopulmonary comorbidities, hypertension, and diabetes, no significant differences in in-hospital mortality, intensive care unit admission, or mechanical ventilation by race/ethnicity were found. Diabetes was a significant predictor for mechanical ventilation (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.11-3.23), while older age was a predictor of in-hospital mortality (OR, 4.18; 95% CI, 1.94-9.04). CONCLUSIONS: In this multicenter cohort of hospitalized COVID-19 patients in the largest health system in Massachusetts, there was no association between race/ethnicity and clinically relevant hospitalization outcomes, including in-hospital mortality, after controlling for key demographic/clinical characteristics. These findings serve to refute suggestions that certain races/ethnicities may be biologically predisposed to poorer COVID-19 outcomes.

A rapid lateral flow immunoassay strip for detection of SARS-CoV-2 antigen using latex microspheres.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly infectious and concealed virus that causes pneumonia, severe acute respiratory syndrome, and even death. Although the epidemic has been controlled since the development of vaccines and quarantine measures, many people are still infected, particularly in third-world countries. Several methods have been developed for detection of SARS-CoV-2, but owing to its price and efficiency, the immune strip could be a better method for the third-world countries. METHODS: In this study, two antibodies were linked to latex microspheres, using 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride and N-hydroxysuccinimide, as the bridge to decrease the cost further and improve the detection performance. The specificity of the lateral flow immunoassay strip (LFIA) was tested by several common viruses and respiratory bacterial infections. Besides, the reproducibility and stability of the LFIAs were tested on the same batch of test strips. Under optimal conditions, the sensitivity of LFIA was determined by testing different dilutions of the positive specimens. RESULTS: The proposed LFIAs were highly specific, and the limit of detection was as low as 25 ng/mL for SARS-CoV-2 antigens. The clinical applicability was evaluated with 659 samples (230 positive and 429 negative samples) by using both LFIA and rRT-PCR. Youden's index (J) was used to assess the performance of these diagnostic tests. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. The sensitivity and specificity were 98.22% and 97.93%, respectively, and J is 0.9615. In addition, the consistency of our proposed LFIA was analyzed using Cohen's kappa coefficient (κ = 0.9620). CONCLUSION: We found disease stage, age, gender, and clinical manifestations have only a slight influence on the diagnosis. Therefore, the lateral flow immunoassay SARS-CoV-2 antigen test strip is suitable for point-of-care detection and provides a great application for SARS-CoV-2 epidemic control in the third-world countries.

Harnessing Event Report Data to Identify Diagnostic Error During the COVID-19 Pandemic.

INTRODUCTION: COVID-19 exposed systemic gaps with increased potential for diagnostic error. This project implemented a new approach leveraging electronic safety reporting to identify and categorize diagnostic errors during the pandemic. METHODS: All safety event reports from March 1, 2020, to February 28, 2021, at an academic medical center were evaluated using two complementary pathways (Pathway 1: all reports with explicit mention of COVID-19; Pathway 2: all reports without explicit mention of COVID-19 where natural language processing [NLP] plus logic-based stratification was applied to identify potential cases). Cases were evaluated by manual review to identify diagnostic error/delay and categorize error type using a recently proposed classification framework of eight categories of pandemic-related diagnostic errors. RESULTS: A total of 14,230 reports were included, with 95 (0.7%) identified as cases of diagnostic error/delay. Pathway 1 (n = 1,780 eligible reports) yielded 45 reports with diagnostic error/delay (positive predictive value [PPV] = 2.5%), of which 35.6% (16/45) were attributed to pandemic-related strain. In Pathway 2, the NLP-based algorithm flagged 110 safety reports for manual review from 12,450 eligible reports. Of these, 50 reports had diagnostic error/delay (PPV = 45.5%); 94.0% (47/50) were related to strain. Errors from all eight categories of the taxonomy were found on analysis. CONCLUSION: An event reporting-based strategy including use of simple-NLP-identified COVID-19-related diagnostic errors/delays uncovered several safety concerns related to COVID-19. An NLP-based approach can complement traditional reporting and be used as a just-in-time monitoring system to enable early detection of emerging risks from large volumes of safety reports.

Preliminary safety, tolerability and efficacy results of KN026 in combination with KN046 in patients with HER2 aberrated solid tumors

BackgroundHER2 potently inhibits innate immunity through cGAS–STING signaling,1 Meanwhile HER2 antibody induced ADCP will also lead to macrophage mediated immune suppression. Both preclinical and clinical studies have suggested a coordination of engagement of innate and adaptive immunity with the combination of an anti-HER2 antibody and an immune checkpoint blockade. KN026 is a novel bispecific antibody that simultaneously binds to two distinct HER2 epitopes. KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1/CD80 and CTLA-4 interaction with CD80/CD86. Here we reported the interim results from an ongoing phase Ib dose escalation and expansion study assessing the safety, tolerability and preliminary efficacy for KN026 in combination with KN046 in Patients with HER2 aberrated solid tumors.MethodsThis study enrolled pts with solid tumors who failed available standard of care, HER2 aberration status confirmed locally (HER2 mutation, HER2 amplification and/or HER2 overexpression). Eligible pts received combination of KN026 and KN046 at three dose levels until disease progression, unacceptable toxicity or withdrawal of informed consent (DL1: KN026 20 mg/kg Q2W + KN046 3 mg/kg Q2W;DL2: KN026 20 mg/kg Q2W with loading on Days 1, 8 of Cycle 1 + KN046 5 mg/kg Q3W;DL3: KN026 30 mg/kg Q3W with loading on Days 1, 8 of Cycle 1 + KN046 5 mg/kg Q3W). Tumor response was evaluated Q8W per RECIST 1.1. Primary endpoint was DLT and key secondary endpoints were efficacy parameters (ORR, DOR, PFS).ResultsAs of the Sep. 08, 2020, 25 pts were enrolled into DL1 (n = 20, 3 for dose escalation), DL2 (n = 3) and DL3 (n = 2) (mGC/GEJ 15 pts;mCRC 8 pts;other solid tumors 2 pts). 15 pts remained on the study treatment and 10 pts discontinued treatment due to disease progression (n=5), death (n=2) and other reasons (n=3). 18 pts had HER2-positive status (12 of 18 failed previous trastuzumab therapy), 2 pts had HER2 mutation and 5 pts had HER2 low expression (without FISH amplification). No DLTs were observed. No pts experienced LVEF decreased or other clinically meaningful cardiac AEs. Treatment-related TEAEs occurred in 23 (92%) pts, of which 6 (24%) pts experienced grade 3 or above treatment-related TEAEs. 11 (44%) pts experienced irAEs, majority were of grade 1 or 2 except that 1 patient experienced grade 3 immune-mediated endocrinopathy. The most common (frequency ≥ 15%) KN026 or KN046 related TEAEs were infusion related reaction (n=11, 44.0%), anaemia (n=9, 36.0%), white blood cell count decreased (n=6, 24.0%), diarrhea (n=5, 20.0%), AST increased (n=5, 20.0%), platelet count decreased (n=5, 20.0%), rash (n=5, 20.0%) and ALT increased (n=4, 16.0%). The objective response rate in pts with HER2-positive tumors (n = 14 efficacy evaluable pts) was 9/14 (64.3%, 95% CI 35.1~87.2%) and disease control rate 13/14 (92.9%, 95% CI 66.1~99.8%). 4 out of 5 pts with HER2 mutation or low expression achieved SD including one patient with SD for more than 24 weeks. 2 death cases due to disease progression were reported, both only received one cycle of KN026 plus KN046 due to COVID-19 restriction.ConclusionsKN026 combined with KN046 is well tolerated and has demonstrated preliminary albeit profound anti-tumor activity in HER2-positive solid tumors.Trial RegistrationClinical trial information: NCT04040699ReferenceShiying Wu, Qian Zhang, Fei Zhang, et al. HER2 recruits AKT1 to disrupt STING signalling and suppress antiviral defence and antitumour immunity. Nature Cell Biology 2019;21:1027–1040.

Preliminary safety, tolerability and efficacy results of KN026 (a HER2-targeted Bispecific Antibody) in combination with KN046 (an anti-PD-L1/CTLA-4 Bispecific Antibody) in patients (pts) with HER2 aberrated solid tumors

BackgroundHER2 potently inhibits innate immunity through cGAS–STING signalling,1 meanwhile HER2 antibody induced ADCP will also lead to macrophage mediated immune suppression. Preclinical and clinical studies suggested a coordination of engagement of innate and adaptive immunity with the combination of an anti-HER2 antibody and an immune checkpoint blockade. KN026 is a novel bispecific antibody that simultaneously binds to two distinct HER2 epitopes. KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86. Here we reported the interim results from an ongoing phase Ib dose escalation and expansion study assessing the safety, tolerability and preliminary efficacy for KN026 in combination with KN046.MethodsThis study enrolled pts with solid tumors who failed available standard of care, HER2 aberration status confirmed locally (HER2 mutation, HER2 amplification and/or HER2 overexpression). Eligible pts received combination of KN026 and KN046 at two dose levels until disease progression, unacceptable toxicity or withdrawal of informed consent (DL1: KN026 20 mg/kg Q2W + KN046 3 mg/kg Q2W;DL2: KN026 20 mg/kg Q2W with loading on Days 1, 8 of Cycle 1 + KN046 5 mg/kg Q3W). Tumor response was evaluated Q8W per RECIST 1.1. Primary endpoint was DLT and key secondary endpoints were efficacy parameters (ORR, DOR, PFS).ResultsAs of the Jul. 13, 2020, 21 pts were enrolled into DL1 (n = 18, 3 for dose escalation) and DL2 (n = 3) (mGC/GEJ 12 pts;mCRC 7 pts;other solid tumors 2 pts). 11 pts remained on the study treatment and 10 pts discontinued treatment due to disease progression (n=5), death (n=2) and other reasons (n=3). 15 pts had HER2-positive status (11 of 15 failed previous trastuzumab therapy), 1 pts had HER2 mutation and 5 pts had HER2 low expression (without FISH amplification). No DLTs were observed. No pts experienced LVEF decreased or other clinically meaningful cardiac AEs. Treatment-related TEAEs occurred in 13 pts, of which 1 pts experienced grade 3 or above treatment-related TEAEs. 7 pts experienced irAEs, all of which were grade 1 or 2. The most common (≥ 10%) KN026 or KN046 related TEAEs were anaemia (n=5, 23.8%), AST increased (n=4, 19.0%), rash (n=4, 19.0%), diarrhea (n=4, 19.0%), blood bilirubin increased (n=3, 14.3%) and infusion related reaction (n=3, 14.3%). The objective response rate in pts with HER2-positive tumors (n = 7 efficacy evaluable pts) was 4/7 (57.1%, 95% CI 18.4~90.1%) and disease control rate 6/7 (85.7%, 95% CI 42.1~99.6%). 3 pts with HER2 mutation or low expression achieved SD including one patient with SD for more than 24 weeks. 2 death cases only received one cycle of KN026 plus KN046 due to COVID-19 restriction before died from clinical deterioration from underlying tumors.ConclusionsKN026 combined with KN046 is well tolerated and has demonstrated profound anti-tumor activity in HER2-positive solid tumors.Trial RegistrationNCT04040699Ethics ApprovalThe study was approved by Beijing Cancer Hospital Institution’s Ethics Board, approval number 2019YJZ37.ConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.ReferenceShiying Wu, Qian Zhang, Fei Zhang, et al. HER2 recruits AKT1 to disrupt STING signalling and suppress antiviral defence and antitumour immunity. Nature Cell Biology 2019;21: 1027–1040.

High Prevalence of Gastrointestinal Manifestations of COVID-19 Infection in Hospitalized Patients With Cancer.

BACKGROUND AND AIM: Gastrointestinal (GI) symptoms have been reported with SARS-CoV-2 infection, but data on the prevalence and severity of GI symptoms in patients with cancer are limited. We sought to characterize the GI manifestations of coronavirus disease-19 (COVID-19) in oncology patients. MATERIALS AND METHODS: We performed a multicenter cohort study of adult patients hospitalized with COVID-19 in 9 Massachusetts medical centers and identified those with an active malignancy. We evaluated the prevalence and severity of GI symptoms among hospitalized COVID-19 patients with cancer. RESULTS: Of 395 hospitalized patients with COVID-19, 36 (9%) had an active malignancy. Of the 36 cancer patients, 23 (63%) reported ≥1 new GI symptom. The most prevalent symptoms were anorexia (12, 52%), diarrhea (9, 39%), and vomiting (8, 35%). GI symptoms were the initial symptom in 4/36 (11%) patients, were the predominant symptom in 5/36 (14%) patients, and were severe in 4/23 (17%) patients. Four of 5 patients with GI symptoms at presentation reported concurrent fever; notably 1 patient had no fever or respiratory symptoms. Twelve (33%) patients had elevations in liver transaminases at presentation; patients with elevated transaminases were more likely to have associated GI symptoms (83% vs. 54%, P=0.04). CONCLUSIONS: Acute GI symptoms associated with COVID-19 are highly prevalent in hospitalized cancer patients and can occur as a presenting symptom without respiratory symptoms. Symptoms are severe in a small subset of patients.

Uncovering people's mask-saving intentions and behaviors in the post-COVID-19 period: Evidence from China.

The COVID-19 pandemic has caused a surge in the demand for medical masks over the past few months. Many countries and regions have experienced a shortage of masks and raw materials, as well as soaring prices. Understanding mask-saving behavior is an important way to help improve medical resource sustainability and respond to the outbreak. This study integrates the theory of planned behavior and normative activation to propose a new comprehensive theoretical framework, which aims to reveal people's mask-saving intentions (MSI) and behaviors in the post-pandemic period. Using the partial least squares structural equation modeling method, a total of 1057 questionnaires randomly collected from China were measured and empirically analyzed. Results indicate the following: (i) Reducing the frequency of going-out is the main approach to saving masks in China, and the majority of people reuse a mask from two to five times. (ii) Personal norms, subjective norms, attitudes and perceived behavioral control all have significant positive effects on MSI; awareness of consequences and ascription of responsibility also indirectly affect MSI through personal norms. (iii) As for extended factors, environmental concerns, perceived risk and information publicity positively affect MSI, but supply chain performance does not have a significant role. (iv) Excessive information publicity may weaken the impact of personal norms, subjective norms and perceived risk on MSI. Given the above findings, some insightful management implications are proposed.

Development and external validation of a prediction risk model for short-term mortality among hospitalized U.S. COVID-19 patients: A proposal for the COVID-AID risk tool.

BACKGROUND: The 2019 novel coronavirus disease (COVID-19) has created unprecedented medical challenges. There remains a need for validated risk prediction models to assess short-term mortality risk among hospitalized patients with COVID-19. The objective of this study was to develop and validate a 7-day and 14-day mortality risk prediction model for patients hospitalized with COVID-19. METHODS: We performed a multicenter retrospective cohort study with a separate multicenter cohort for external validation using two hospitals in New York, NY, and 9 hospitals in Massachusetts, respectively. A total of 664 patients in NY and 265 patients with COVID-19 in Massachusetts, hospitalized from March to April 2020. RESULTS: We developed a risk model consisting of patient age, hypoxia severity, mean arterial pressure and presence of kidney dysfunction at hospital presentation. Multivariable regression model was based on risk factors selected from univariable and Chi-squared automatic interaction detection analyses. Validation was by receiver operating characteristic curve (discrimination) and Hosmer-Lemeshow goodness of fit (GOF) test (calibration). In internal cross-validation, prediction of 7-day mortality had an AUC of 0.86 (95%CI 0.74-0.98; GOF p = 0.744); while 14-day had an AUC of 0.83 (95%CI 0.69-0.97; GOF p = 0.588). External validation was achieved using 265 patients from an outside cohort and confirmed 7- and 14-day mortality prediction performance with an AUC of 0.85 (95%CI 0.78-0.92; GOF p = 0.340) and 0.83 (95%CI 0.76-0.89; GOF p = 0.471) respectively, along with excellent calibration. Retrospective data collection, short follow-up time, and development in COVID-19 epicenter may limit model generalizability. CONCLUSIONS: The COVID-AID risk tool is a well-calibrated model that demonstrates accuracy in the prediction of both 7-day and 14-day mortality risk among patients hospitalized with COVID-19. This prediction score could assist with resource utilization, patient and caregiver education, and provide a risk stratification instrument for future research trials.

Impact of chronic liver disease on outcomes of hospitalized patients with COVID-19: A multicentre United States experience.

Liver injury has been described with COVID-19, and early reports suggested 2%-11% of patients had chronic liver disease (CLD). In this multicentre retrospective study, we evaluated hospitalized adults with laboratory-confirmed COVID-19 and the impact of CLD on relevant clinical outcomes. Of 363 patients included, 19% had CLD, including 15.2% with NAFLD. Patients with CLD had longer length of stay. After controlling for age, gender, obesity, cardiac diseases, hypertension, hyperlipidaemia, diabetes and pulmonary disorders, CLD and NAFLD were independently associated with ICU admission ([aOR 1.77, 95% CI 1.03-3.04] and [aOR 2.30, 95% CI 1.27-4.17]) and mechanical ventilation ([aOR 2.08, 95% CI 1.20-3.60] and [aOR 2.15, 95% CI 1.18-3.91]). Presence of cirrhosis was an independent predictor of mortality (aOR 12.5, 95% CI 2.16-72.5). Overall, nearly one-fifth of hospitalized COVID-19 patients had CLD, which was associated with more critical illness. Future studies are needed to identify interventions to improve clinical outcomes.

Clinical trial analysis of 2019-nCoV therapy registered in China.

So far, there is a lack of effective drugs for the new coronavirus pneumonia. With more and more patients diagnosed, China has carried out more than 100 clinical studies of new coronavirus infection, including antiviral drugs, antimalarial drugs, glucocorticoids, plasma therapy, virus vaccine, and other Western drugs, while Chinese medicine research accounted for half of the studies. Most of the trials were initiated by investigators and the study period would last for 1 to 11 months. The primary endpoints included symptom improvement and virus nucleic acid turning negative, but the optimal endpoint has not been determined. Although the final results of studies will take a long time to complete, the interim research data may provide some help for the current urgent demand for drug treatment. Compared with that of during SARS period in 2003, China has the stronger capability to carry out clinical trials of new drugs in emergency period.