ABSTRACT
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.
Subject(s)
COVID-19 , Sofosbuvir , Adult , Antiviral Agents/therapeutic use , Carbamates , Humans , Imidazoles , Pyrrolidines , SARS-CoV-2 , Sofosbuvir/therapeutic use , Treatment Outcome , Valine/analogs & derivativesABSTRACT
OBJECTIVE: Coronavirus disease 2019 (COVID-19) is a novel pandemic. Considerable differences in disease severity and the mortality rate have been observed in different parts of the world. The present study investigated the characteristics and outcomes of patients hospitalized with COVID-19 in Iran. METHODS: We established a retrospective cohort to study hospitalized COVID-19 patients in Iran. Epidemiological, imaging, laboratory, and clinical characteristics and outcomes were recorded from medical documents. The chi-square test, t-test, and logistic regression models were used to analyze the data. A p<0.05 was considered to indicate statistical significance. RESULTS: In total, 364 cases (207 males and 157 females) were analyzed. The most common symptoms were cough, fever, and dyspnea. Multifocal bilateral ground-glass opacities with peripheral distribution were the predominant imaging finding. The mean age of patients was 54.28±18.81 years. The mean age of patients who died was 71.50±14.60 years. The mortality rate was 17.6%. The total proportion of patients with a comorbidity was 47.5%, and 84.4% of patients who died had a comorbidity. Sex, history of diabetes mellitus, and dyslipidemia were not significantly associated with mortality (p>0.05). However, mortality showed significant relationships with body mass index; age; history of hypertension, chronic kidney disease (CKD), ischemic heart disease, cerebrovascular accident (CVA), pulmonary disease, and cancer; and abnormal high-resolution computed tomography (HRCT) findings (p<0.05 for all). Cancer had the highest odds ratio. CONCLUSION: Comorbidities (especially cancer, CKD, and CVA), severe obesity, old age, and abnormal HRCT findings affected the health outcomes of patients hospitalized with COVID-19.