Determination of the Efficacy of Daclatasvir Plus Sofosbuvir in Patients with Acute ‎Respiratory Coronavirus Syndrome (SARS-COV-2): A Randomized Clinical Trial

To tackle the 2019 coronavirus infection (COVID-19) disease pandemic, effective antiviral therapy is critical. We assessed the efficacy of sofosbuvir and daclatasvir for treating patients with COVID-19.  This was a randomized controlled trial in adults with moderate-to-severe COVID-19 disease admitted to Razi Teaching Hospital in Ahvaz, Khuzestan Province, Iran. Patients were randomly assigned to the sofosbuvir and daclatasvir group (n=35, intervention group) and control group (n=35, standard care). The primary endpoint of this study was the length of hospital stay, clinical improvement, mechanical ventilation, mortality, and side effect. We found that the combination of Daclatasvir and Sofosbuvir (DCV+SOF) did not make a statistically significant difference in terms of mortality. There was no significant difference in the duration of hospitalization between the two groups. The two groups did not differ significantly in terms of the frequency of side effects. There were 2 cases of intubation and death in both groups. The medications used in this study, i.e, the combination of daclatasvir and sofosbuvir, failed to show a significant effect in patients, and despite promising laboratory studies, there were no improvements observed in vital signs and the indicators studied, including clinical signs. Hospitalization days, ventilator requirements and mortality did not make a significant difference. To confirm the results of this study, conducting researches with a larger sample size are needed.