Abstract
Background: Favipiravir is an antiviral agent, mechanism of action is selective inhibition of RNA-dependent RNA polymerase and maybe effective against the SARS-CoV-2 virus. While no established treatment for COVID-19 is available, epidemiological studies conducted to date suggest a risk of further increase in patient exposure in the future. Therefore, to verify that the efficacy of Favipiravir exceeds that of the supportive care (symptomatic therapy) in mild SARS-CoV-2 infected patients (COVID-19 patients) without pneumonia, using the time required to improve clinical symptoms as the primary endpoint and it will contribute immensely to the improvement of public health in the future. Methods: To verify that the efficacy of Favipiravir exceeds that of the supportive care (symptomatic therapy) in mild SARS-CoV-2 infected patients (COVID-19 patients) without pneumonia, using the time required to improve clinical symptoms as the primary endpoint. In the case of chest imaging, no new findings and turning negative in the RT-PCR test with nasopharyngeal swab were set as the primary endpoints. Since this study is an open-label study, 96 patients to be enrolled all of the following inclusion criteria. (2:1, 64 in Favipiravir group with 1,800/800 mg twice daily) for 5-14 days and 32 in control group) The treatment period is 5 -14 days in principle and 10 patients in a clinical pharmacology study of Favipiravir. Results: This study examine the superiority of treatment of Favipiravir adding to the supportive care for mild COVID-19 patients without pneumonia, compared to those treatments without Favipiravir, to efficacy improve clinical symptoms with using NEWS Score, the treatment period is 14 days , in Favipiravir group have improved clinical symptoms rate 79% and in control group rate 32.3%. (p=0.027) Half of those treatments with Favipiravir have improved clinical symptoms on Day 2. As for in control group have improved clinical symptoms on Day 14 (p<0.001) Therefore, efficacy of Favipiravir to improve clinical symptoms than the control group. Conclusions: Coronavirus disease 2019, treatment with Favipiravir 1,800 mg is orally administered twice on Day 1, and then 800 mg is orally administered twice daily on Day 2 when you have mild symptoms.
