| dc.contributor.author | Chen, Chang, et al. Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China | |
| dc.description.abstract | Importance: WHO has made the assessment that coronavirus disease 2019 (COVID-19) can be characterized as a pandemic. But there is no effective antiviral drug for COVID-19 so far. Objective: To compare the efficacy and safety of favipiravir and arbidol to treat COVID-19 patients on 7 day′s clinical recovery rate. Design: Prospective, multicenter, open-label, randomized superiority trial in February, 2020. Setting: Multicenter study. Participants: Patients with confirmed COVID-19 admitted to 3 hospitals from Feb 20, 2020 to Mar 12, 2020. Interventions: Conventional therapy + favipiravir or arbidol. Main Outcomes and Measures: The primary outcome was 7 day′s clinical recovery rate. Duration of fever, cough relief time and auxiliary oxygen therapy or noninvasive mechanical ventilation rate were the secondary outcomes. The patients with chest CT imaging and laboratory-confirmed COVID-19 infection, aged 18 years or older were randomly assigned to receive favipiravir or arbidol. Safety data were collected for a further 1 weeks′ follow-up. Results: 120 patients were assigned to favipiravir group (116 assessed) and 120 to arbidol group (120 assessed). In FAS cohort, for ordinary patients with COVID-19, 7 day′s clinical recovery rate was 55.86% in the arbidol group and 71.43% in the favipiravir group (P = 0.0199). For ordinary COVID-19 patients and COVID-19 patients with hypertension and/or diabetes, the time of fever reduction and cough relief in favipiravir group was significantly shorter than that in arbidol group (both P < 0.001), but there was no statistical difference was observed of auxiliary oxygen therapy or noninvasive mechanical ventilation rate (both P > 0.05). The most possible adverse events were abnormal LFT, psychiatric symptom reactions, digestive tract reactions and raised serum uric acid (3 [2.50 %] in arbidol group vs 16 [13.79%] in favipiravir group, P < 0.0001). Conclusions and Relevance: In ordinary COVID-19 patients untreated with antiviral previously, favipiravir can be considered as a preferred treatment because of its′ higher 7 day′s clinical recovery rate and more effectively reduced incidence of fever, cough except some antiviral-associated adverse effects. Trial Registration: This study is registered with Chictr.org.cn, number ChiCTR200030254. | en_US |
