Favipiravir versus Arbidol for COVID-19: A Randomized Clinical Trial

Key points
Question: How about the efficacy and safety of favipiravir to treat COVID-19 patients?

Findings: Compared to arbidol, in moderate COVID-19 patients untreated with antiviral previously, favipiravir shown superior efficacy in terms of clinical recovery rate of day 7 and reduced incidence of fever, cough with manageable antiviral-associated adverse effects.

Meaning: Favipiravir can be considered as a preferred treatment approach to moderate COVID-19 pneumonia.

Abstract

Importance: WHO has made the assessment that coronavirus disease 2019

(COVID-19) can be characterized as a pandemic. So far, there is no clinically proven effective antiviral drug for COVID-19.

Objective: To compare the efficacy and safety of favipiravir and arbidol to treat COVID-19 patients on clinical recovery rate of day 7.

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 clinical recovery rate of day 7. 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 further follow-up for a week.

Results: 120 patients were assigned to favipiravir group (116 assessed) and 120 to arbidol group (120 assessed). In full analysis set (FAS) cohort, for moderate patients with COVID-19, clinical recovery rate of day 7 was 55.86% in the arbidol group and 71.43% in the favipiravir group (P=0.0199). For moderate COVID-19 patients and COVID-19 patients with hypertension and/or diabetes, the latency to 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 frequently observed treatment-associated 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 moderate COVID-19 patients untreated with antiviral previously, favipiravir can be considered as a preferred treatment compared to arbidol because of superior clinical recovery rate of day 7 and more effectively reduced incidence of fever, cough besides some manageable antiviral-associated adverse effects.

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