Clinical utility of repurposing a short course of hepatitis C drugs for COVID19. A randomized controlled study

BACKGROUND Preliminary 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. METHODS Eighty-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. RESULTS The 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. CONCLUSION This 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. HIGHLIGHTS ### Competing Interest Statement SH and OE are employees of Pharco, SH holds stock in Pharco. MY conducted clinical studies and provided consultations to Pharco. All other authors have nothing to declare. The funder of the research played no decision-making role in the design, execution, analysis or reporting of the research and we have not received any assistance of a professional medical writer or similar services. No author accepted any reimbursement for preparing this article. ### Clinical Trial The study protocol was registered in the German clinical trial database repository with trial id: (DRKS00022203) ### Funding Statement Pharco Corporate supported the study medications. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was reviewed and approved by the Research Ethics Committee of Faculty of Medicine, Alexandria University (IRB00007555) and the Central Egyptian Ministry of Health and People Research Ethics Committee according to the Declaration of Helsinki. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.