Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing, China; Department of Infectious Disease, Peking University International Hospital, Beijing, China.
Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing, China.
Int Immunopharmacol. 2021 Aug;97:107702. doi: 10.1016/j.intimp.2021.107702. Epub 2021 Apr 21.
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.
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.
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.
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.
新冠病毒（SARS-CoV-2）感染者康复后核酸检测复阳患者的临床特征和治疗方法仍不清楚。有效的抗病毒治疗对这类患者至关重要。我们评估了法维拉韦治疗此类患者的疗效和安全性。
这是一项多中心、开放标签、随机对照临床试验，纳入 SARS-CoV-2 核酸复阳患者。患者按 2:1 的比例随机分配，分别接受法维拉韦联合标准治疗或标准治疗。主要结局为连续两次（间隔超过 24 小时）鼻咽拭子和痰液样本 SARS-CoV-2 RNA 检测均为阴性的时间。
2020 年 3 月 27 日至 5 月 9 日，55 例患者接受随机分组，其中 36 例分配至法维拉韦组，19 例分配至对照组。法维拉韦组从开始研究治疗到鼻咽拭子和痰液样本均转为阴性的时间明显短于对照组（中位数 17 天 vs. 26 天）；风险比 2.1（95%可信区间[1.1-4.0]，p=0.038）。法维拉韦组的病毒脱落比例高于对照组（80.6%[29/36]vs.52.6%[10/19]，p=0.030）。法维拉韦组治疗后 C 反应蛋白明显下降（p=0.016）。不良事件一般较轻且为自限性。
与对照组相比，法维拉韦在缩短出院后 SARS-CoV-2 核酸复阳患者的病毒脱落时间方面安全且更有效。然而，需要更大规模和随机、双盲、安慰剂对照试验来证实我们的结论。
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