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Efficacy of Favipiravir in treatment of mild & moderateCOVID-19 infection in Nepal: a multi-center, randomized, open-labelled, phase III clinical trial

The pandemic of COVID-19 has been a global public health emergency, with not a single antiviral drug being approved for treatment so far, except for Remdesivir. We sought to evaluate the efficacy of repurposed use of Favipiravir in the clinical outcomes of mild and moderate COVID-19 cases in Nepal. Methods: We conducted a multicenter, randomized (1:1), open labeled, phase III clinical trial among adults diagnosed with mild to moderate COVID-19 infections, as an inpatient or outpatient basis. Patients with mild symptoms were randomly assigned to receive Favipiravir (study regimen: oral form, 1800 mg twice on Day1 and then 800mg twice daily for 5 days) or matching placebo. Those with moderate symptoms were randomly allocated to receive either Favipiravir (study regimen for 10 days) or intravenous Remdesivir (200mg on Day 1, followed by 100mg once daily for 5days). The primary outcome was to evaluate for clinical improvement among both the cohorts based on treatment received. Here, we report an interim safety and efficacy analysis of the study. Results: Between January 2021 to March 2021, a total of 90 cases (Mild: 70, Moderate: 20) with 61% being male, were enrolled from 8 different centers. The result of analysis on clinical efficacy has been as reported in the table submitted herewith. There was one minor event of increment in uric acid level and two events of elevated liver enzymes observed, however none of the adverse events required any hospital admissions or special intervention. We conclude that Favipiravir has an excellent safety profile but we need to achieve a bigger sample size in order to evaluate for any possible efficacy in treatment of mild & moderate COVID-19 cases.

Author(s):  Prabhat Adhikari, Janak Koirala, Pradip Gyanwali, Suman Pant

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