ABSTRACT

We investigated Favipiravir (FPV) efficacy in mild cases of COVID-19 without pneumonia and its effects towards viral clearance, clinical condition, and risk of COVID-19 pneumonia development. PCR-confirmed SARS-CoV-2-infected patients without pneumonia were enrolled (2:1) within 10 days of symptomatic onset into FPV and control arms. The former received 1800 mg FPV twice-daily (BID) on Day 1 and 800 mg BID 5–14 days thereafter until negative viral detection, while the latter received only supportive care. The primary endpoint was time to clinical improvement, defined by a National Early Warning Score (NEWS) of ≤1. 62 patients (41 female) comprised the FPV arm (median age: 32 years, median BMI: 22 kg/m²) and 31 patients (19 female) comprised the control arm (median age: 28 years, median BMI: 22 kg/m²). The median time to sustained clinical improvement, by NEWS, was 2 and 14 days for FPV and control arms, respectively (adjusted hazard ratio (aHR) of 2.77, 95% CI 1.57–4.88, P < .001). The FPV arm also had significantly higher likelihoods of clinical improvement within 14 days after enrolment by NEWS (79% vs. 32% respectively, P < .001). 8 (12.9%) and 7 (22.6%) patients in FPV and control arms developed mild pneumonia at a median (range) of 6.5 (1–13) and 7 (1–13) days after treatment, respectively (P = .316). All recovered well without complications. We can conclude that early treatment of FPV in symptomatic COVID-19 patients without pneumonia was associated with faster clinical improvement.

Trial registration: Thai Clinical Trials Registry identifier: TCTR20200514001.

摘要

我们研究了法匹拉韦 (FPV) 在无肺炎的轻度 COVID-19 病例中的疗效及其对病毒清除、临床状况和 COVID-19 肺炎发展风险的影响。在症状发作后 10 天内，将经 PCR 确认的 SARS-CoV-2 感染患者纳入 FPV 和对照组（2:1）。前者在第 1 天接受 1800 mg FPV，每天两次 (BID)，之后 5-14 天接受 800 mg FPV，直到病毒检测阴性，而后者仅接受支持性护理。主要终点是临床改善时间，由≤1的国家早期预警评分（NEWS）定义。62 名患者（41 名女性）组成 FPV 组（中位年龄：32 岁，中位 BMI：22 kg/m²），31 名患者（19 名女性）组成对照组（中位年龄：28 岁，中位 BMI：22 kg/m² ）。P  < .001)。FPV 组在 NEWS 入组后 14 天内临床改善的可能性也显着增加（分别为 79% 和 32%，P  < .001）。FPV 和对照组分别有 8 (12.9%) 和 7 (22.6%) 名患者在治疗后 6.5 (1-13) 天和 7 (1-13) 天出现轻度肺炎 ( P  = .316 ）。一切都恢复得很好，没有并发症。我们可以得出结论，在没有肺炎的有症状的 COVID-19 患者中早期治疗 FPV 与更快的临床改善相关。

试验注册：泰国临床试验注册标识符：TCTR20200514001。