Abstract
Background: The clinical characteristics and treatment of patients who tested positive for COVID-19 after recovery remained elusive. Effective antiviral therapy is important for tackling these patients. We assessed the efficacy and safety of favipiravir for treating these patients.
Methods: This is a multicenter, open-label, randomized controlled trial in SARS-CoV-2 RNA re-positive patients. Patients were randomly assigned in a 2:1 ratio to receive either favipiravir, in addition to standard care, or standard care alone. The primary outcome was time to achieve a consecutive twice (at intervals of more than 24 h) negative RT-PCR result for SARS-CoV-2 RNA in nasopharyngeal swab and sputum sample.
Results: Between March 27 and May 9, 2020, 55 patients underwent randomization; 36 were assigned to the favipiravir group and 19 were assigned to the control group. Favipiravir group had a significantly shorter time from start of study treatment to negative nasopharyngeal swab and sputum than control group (median 17 vs. 26 days); hazard ratio 2.1 (95% CI [1.1-4.0], p = 0.038). The proportion of virus shedding in favipiravir group was higher than control group (80.6% [29/36] vs. 52.6% [10/19], p = 0.030, respectively). C-reactive protein decreased significantly after treatment in the favipiravir group (p = 0.016). The adverse events were generally mild and self-limiting.
Conclusion: Favipiravir was safe and superior to control in shortening the duration of viral shedding in SARS-CoV-2 RNA recurrent positive after discharge. However, a larger scale and randomized, double-blind, placebo-controlled trial is required to confirm our conclusion.
Keywords: COVID-19; Favipiravir; Recurrent positive; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Favipiravir, Recurrent positive, 【초록키워드】 Randomized controlled trial, Treatment, SARS-CoV-2, antiviral therapy, Open-label, randomization, Clinical characteristics, viral shedding, Favipiravir, C-reactive protein, sputum, RT-PCR, virus, discharge, adverse events, Randomized, Nasopharyngeal swab, Virus shedding, placebo-controlled trial, adverse event, Patient, Controlled trial, Efficacy and safety, SARS-CoV-2 RNA, multicenter, Recurrent, patients, Safe, double-blind, Primary outcome, control group, 95% CI, standard care, hazard ratio, self-limiting, positive, intervals, negative RT-PCR, Randomly, tested, significantly, proportion, addition, remained, required, median, assigned, interval, receive, generally mild, significantly shorter, 【제목키워드】 Treatment, randomized trial, Favipiravir, RNA, multicenter, positive, patients with SARS-CoV-2,