ABSTRACT
BACKGROUNDPreliminary data suggests a potential therapeutic benefit for the hepatitis C drugs, sofosbuvir (SOF) and daclatasvir (DCV) for the treatment of COVID-19. We aim to evaluate efficacy of a short course of dual sofosbuvir/daclatasvir in patients with COVID-19. METHODSEighty-nine consecutive eligible patients were randomly assigned to two treatment groups. The experimental group was treated with the standard of care (SOC) therapy in addition to one 400 mg tablet sofosbuvir and one 60 mg daclatasvir daily for 10 days; while the control group was treated with the SOC therapy alone. Baseline clinical data was measured and followed up for 21 days. Data was compared between the two treatment groups. RESULTSThe proportion of cumulative clinical recovery in the experimental group at day 21 was numerically greater than the control group (40/44 (91%; 95%CI: 78.8-96.4%) versus 35/45 (77.8%; CI 63.7-87.5%)). The Hazard Ratio (HR) for time to clinical recovery adjusted for baseline severity, using a Cox-regression model was statistically significant: HR: 1.59 (95%CI: 1.001-2.5). Concordantly, the experimental group also showed trends for greater improvement in the mean 8-points ordinal scale score, the severity of lung lesions score and the case fatality rate (4.5% versus 11.1%). No serious or severe adverse events were reported in both groups. CONCLUSIONThis study supports potential benefit and safety of sofosbuvir combined with daclatasvir when given early in the treatment of COVID-19. We hope to encourage further large sized, multinational studies to confirm the results. HIGHLIGHTSO_LIPreliminary data suggests a potential therapeutic benefit for the hepatitis C drugs, sofosbuvir (SOF) and daclatasvir (DCV) for the treatment of COVID-19. C_LIO_LIEighty-nine COVID-19 patients were randomly assigned to either treatment with SOC plus a short course of combined SOF/DCV therapy or SOC therapy alone. C_LIO_LIThe Hazard Ratio (HR) for time to clinical recovery adjusted for baseline severity showed statistical significance: HR: 1.59 (95%CI: 1.001-2.5). Concordantly, all other efficacy endpoints showed numerical trends for greater improvement in the experimental group including the case fatality rate (4.5% versus 11.1%). No serious or severe adverse events were reported in both groups. C_LIO_LISOF/DCV therapy might be beneficial when given early in the treatment of COVID-19. C_LI
