COVID-19 has rapidly become a global challenge. 1 We read with interest the article by Bezzio et al 1 that reported the characteristics and outcomes of COVID-19 patients with pre-existing IBD. Patients with pre-existing cirrhosis, who have immune dysfunction and poorer outcomes from acute respiratory distress syndrome (ARDS) than patients without cirrhosis, are also considered a high-risk population for COVID-19. 2 3 In previous studies, the proportion of COVID-19 patients with pre-existing liver conditions ranged from 2% to 11%. 2 However, the clinical course and risk factors for mortality in these patients has not yet been reported. This retrospective multicentre study (COVID-Cirrhosis-CHESS, ClinicalTrials. gov NCT04329559) included consecutive adult patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and pre-existing cirrhosis from 16 designated hospitals in China between 31 December 2019 and 24 March 2020. Patient characteristics are summarised in table 1. Twenty-one COVID-19 patients with preexisting cirrhosis (Child-Pugh class A, B and C in 16, 3 and 2 patients, respectively) were included in the analysis. The median age was 68 years; 11 (52.4%) were male. Most patients had compensated cirrhosis (81.0%) and chronic HBV infection was the most common aetiology (57.1%). Comorbidities other than cirrhosis were present in most patients (66.7%). In previous studies, older age, male sex and pre-existing comorbidities were associated with higher risk of mortality for COVID-19. 4 5 Here, there were no significant differences between survivors (n=16) and non-survivors (n=5) in age, sex, comorbidities, aetiology of cirrhosis, stage of cirrhosis, Child-Pugh class, Model for End-stage Liver Disease (MELD) score, interval between onset and admission, or onset symptoms of COVID-19. Comorbidities have been associated with adverse outcomes in cirrhosis, 6 but our analysis did not show clear prognostic associations-possibly due to the small size and narrow composition of the study population.
medRxiv preprint 6 datasets. The predictive performance was further evaluated in test dataset on lung lobe-and patients-level. Main outcomesShort-term hospital stay (≤10 days) and long-term hospital stay (>10 days). ResultsThe CT radiomics models based on 6 second-order features were effective in discriminating short-and long-term hospital stay in patients with pneumonia associated with SARS-CoV-2 infection, with areas under the curves of 0.97 (95%CI 0.83-1.0) and 0.92 (95%CI 0.67-1.0) by LR and RF, respectively, in the test dataset. The LR model showed a sensitivity and specificity of 1.0 and 0.89, and the RF model showed similar performance with sensitivity and specificity of 0.75 and 1.0 in test dataset. ConclusionsThe machine learning-based CT radiomics models showed feasibility and accuracy for predicting hospital stay in patients with pneumonia associated with SARS-CoV-2 infection.All rights reserved. No reuse allowed without permission.author/funder, who has granted medRxiv a license to display the preprint in perpetuity. Results Patient characteristicsA total of 52 patients with laboratory-confirmed SARS-CoV-2 infection and initial CT images were enrolled from 5 designated hospitals in Ankang, Lishui, Zhenjiang, Lanzhou, and Linxia, China. As of February 20, 14 patients were still hospitalized, and 7 patients had non-findings in CT images. Therefore, 31 patients with 72 lesion segments were included in the final analysis. The training and inter-validation cohort comprised 26 patients (12 from Ankang, 8 from Lishui, 4 from Lanzhou, and 2 from Linxia) with 59 lesion segments, and test cohort comprised 5 patients from Zhenjiang with 13 lesion segments. The median age was 38.00 (interquartile range, 26.00-47.00) years and 17 (57%) were male. Comorbidities, symptoms and laboratory findings at admission were summarized in Table 1. Performance of CT radiomics modelThe CT radiomics model, based on 6 features (supplementary Table1), showed the highest AUC on the training and inter-validation dataset. The performance of modeling using LR and RF methods was shown in Figure 2. On lung lobe-level, models using LR method significantly distinguished short-and long-term hospital stay (In training and inter-validation datasets, cut-off value 0.31, AUC 0.94 (95%CI 0.92-0.97), sensitivity 1.0, specificity 0.87, NPV 1.0, and PPV 0.88; In test dataset, AUC 0.97 (95%CI 0.83-1.0), sensitivity 1.0, specificity 0.89, NPV 1.0, and PPV 0.8). Besides, models using RF method obtained satisfied results (In training and inter-validation datasets, cut-off value 0.68, AUC 1.0 (95%CI 1.0-1.0), All rights reserved. No reuse allowed without permission.author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Background and aims We aim to assess the safety and immunogenicity of inactivated whole-virion SARS-CoV-2 vaccines in patients with chronic liver diseases (CLD) in this study. Methods This was a prospective, multi-center, open-label study. Participants aged over 18 years with confirmed CLD and healthy volunteers were enrolled. All participants received 2 doses of inactivated whole-virion SARS-CoV-2 vaccines. Adverse reactions were recorded within 14 days after any dose of SARS-CoV-2 vaccine, laboratory testing results were collected after the second dose, and serum samples of enrolled subjects were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Results A total of 581 participants (437 patients with CLD and 144 healthy volunteers) were enrolled from 15 sites in China. Most adverse reactions were mild and transient, and injection site pain (36 [8.2%]) was the most frequently reported adverse event. Three participants had Grade 3 aminopherase elevation (defined as alanine aminopherase>5 upper limits of normal) after the second dose of inactivated whole-virion SARS-CoV-2 vaccination, and only one of them was judged as severe adverse event potentially related to SARS-CoV-2 vaccination. The positive rates of SARS-CoV-2 neutralizing antibodies were 76.8% in non-cirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group (P=0.894 among CLD subgroups) and 90.3% in healthy controls (P=0.008 versus CLD group). Conclusion Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunological response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in non-cirrhotic CLD, compensated cirrhosis and decompensated cirrhosis.
Background & Aims The development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD. Methods This multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination. Results A total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0–48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m 2 (IQR 23.8–28.1 kg/m 2 ). The number of adverse reactions within 7 days after each injection and adverse reactions within 28 days totaled 95 (24.9%) and 112 (29.4%), respectively. The most common adverse reactions were injection site pain in 70 (18.4%), followed by muscle pain in 21 (5.5%), and headache in 20 (5.2%). All adverse reactions were mild and self-limiting, and no grade 3 adverse reactions were recorded. Notably, neutralizing antibodies against SARS-CoV-2 were detected in 364 (95.5%) patients with NAFLD. The median neutralizing antibody titer was 32 (IQR 8-64), and the neutralizing antibody titers were maintained. Conclusions The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD. Lay summary The development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with non-alcoholic fatty liver disease.
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