Objectives Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19. Methods Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality. Results Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P < 0.01). Conclusions Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.
Introduction: Needless to say that correct and real-time detection and effective prognosis of the COVID-19 are necessary to deliver the best possible care for patients and, accordingly, diminish the pressure on the healthcare industries. Hence our paper aims to present an intelligent algorithm for selecting the best features from the dataset and developing Machine Learning(ML) based models to predict the COVID-19 and finally opted for the best-performing algorithm. Methods: In this developmental study, the clinical data of 1703 COVID-19 and non-COVID-19 patients Using a single-center registry from February 9, 2020, to December 20, 2020, were used. The Minimum Redundancy Maximum Relevance (mRMR) feature selection algorithm identified the most relevant variables. Then, chosen features feed into the several data mining methods, including K-Nearest Neighbors, AdaBoost Classifier, Decision Tree, HistGradient Boosting Classifier, and Support Vector Machine. A 10-fold cross-validation method and six performance evaluation metrics were used to evaluate and compare these implemented algorithms, and finally, the best model was implemented. Results: Out of the 34 included features, 11 variables were selected as the essential features. The results of using ML algorithms indicated that the best performance belongs to the AdaBoost classifier with mean accuracy = 92.9%, mean specificity = 89.3%, mean sensitivity = 94.2%, mean F-measure = 91.6 %, mean KAPA = 94.3% and mean ROC = 92.1 %. Conclusion: The empirical results reveal that the Adaboost model yielded higher performance than other classification models and developed our Clinical Decision Support Systems (CDSS) interface to discriminate positive COVID-19 from negative cases.
Background The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95–1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77–1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.
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