Abstract
Background: In addition to supportive therapy, antiviral therapy is an effective treatment for coronavirus disease 2019 (COVID-19).Objective: To compare the efficacy and safety of favipiravir and umifenovir (Arbidol) to treat COVID-19 patients.Methods: We conducted a prospective, randomized, controlled, open-label multicenter trial involving adult patients with COVID-19. Enrolled patients with initial symptoms within 12 days were randomly assigned in a 1:1 ratio to receive conventional therapy plus Arbidol (200 mg*3/day) or favipiravir (1600 mg*2/first day followed by 600 mg*2/day) for 7 days. The primary outcome was the clinical recovery rate at day 7 of drug administration (relief for pyrexia and cough, respiratory frequency ≤24 times/min; oxygen saturation ≥98%). Latency to relief for pyrexia and cough and the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV)/mechanical ventilation (MV) were the secondary outcomes. Safety data were collected for 17 days.Results: A total of 240 enrolled COVID-19 patients underwent randomization; 120 patients were assigned to receive favipiravir (116 assessed), and 120 patients were assigned to receive Arbidol (120 assessed). The clinical recovery rate at day 7 of drug administration did not significantly differ between the favipiravir group (71/116) and Arbidol group (62/120) (p = 0.1396, difference in recovery rate: 0.0954; 95% CI: −0.0305∼0.2213). Favipiravir contributed to relief for both pyrexia (difference: 1.70 days, p < 0.0001) and cough (difference: 1.75 days, p < 0.0001). No difference was observed in the AOT or NMV/MV rate (both p > 0.05). The most frequently observed favipiravir-associated adverse event was increased serum uric acid (16/116, OR: 5.52, p = 0.0014).Conclusion: Among patients with COVID-19, favipiravir, compared to Arbidol, did not significantly improve the clinical recovery rate at day 7. Favipiravir significantly improved the latency to relieve pyrexia and cough. Adverse effects caused by favipiravir are mild and manageable.
Highlights
Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, was first discovered in Dec. 2019
The main signs and symptoms for enrolled patients were pyrexia, fatigue, dry cough, myalgia, dyspnea, expectoration, sore throat, diarrhea, dizziness, insomnia and conjunctivitis, none of which were significantly different between the groups
Patients who were symptomatic for 10 days or less at the time of enrollment received favipiravir (72.4%) or Arbidol (74.1%) treatment (Table 1)
Summary
Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, was first discovered in Dec. 2019. The main strategies were symptomatic and supportive care, such as maintaining vital signs, maintaining oxygen saturation and blood pressure, and treating complications, such as secondary infections or organ failure. The standard practice of care focuses on treating the clinical symptoms, including pyrexia, cough, and acute respiratory distress syndrome (ARDS), of patients with supportive care, such as fluid management and auxiliary oxygen therapy. No proven clinical efficacy of antiviral agents for COVID-19 has been reported, while some (Remdesivir, hIFNα-2b, Ribavirin, Chloroquine and Arbidol) are currently under clinical trials for COVID-19 (Dong et al, 2020; Wang et al, 2020). In addition to supportive therapy, antiviral therapy is an effective treatment for coronavirus disease 2019 (COVID-19)
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