Evaluating the Therapeutic Effect of Sofosbuvir in Outpatients with COVID-19: A Randomized Clinical Trial Study.

Background: The coronavirus disease 2019 (COVID-19) pandemic has engendered scores of deaths worldwide. Just as the development of varying procedures during the pandemic has helped inhibit the disease, none is considered a definitive treatment protocol for this problem, as each induces some clinical complications pertinent to the disease. This study thus assessed the early use of sofosbuvir in outpatients with mild COVID-19.

Materials and methods: This randomized clinical trial study was conducted on 360 patients with mild COVID-19 infection at 17 Shahrivar Ahvaz Health Center. These patients were randomly divided into the intervention and control groups. Both the control and intervention groups received 400 mg of sofosbuvir and a placebo for seven days, respectively. After 14 days from the onset of the treatment, the duration of symptoms, the necessity of hospitalization, the mean of hospitalization duration, and mortality were assessed.

Results: The most common symptoms in the intervention and control groups were coughs with a frequency of 46 (25.6%) and 54(30%), respectively. The two groups showed no statistically significant difference in the frequency of the first observed clinical symptom related to the disease (P=0.2). The mean days that the patients were symptomatic in the control group were 14±4.17, whereas, in the intervention group, it was 12.12±3.15 (P=0.08). The frequency of hospitalization in the control and intervention groups was 7 (3.8%) and 4 (2.22%), respectively (P=0.11). Moreover, the mean days of hospitalization in the control and the intervention groups were 4±1.1 and 3±0.8, respectively (P=0.15). In addition, the two groups had a similar frequency of hospitalization in the ICU (0) and mortality rate (0).

Conclusion: Sofosbuvir alone cannot play a significant role in the treatment of outpatients with mild COVID-19.