Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
J Infect. 2024 Oct;89(4):106248. doi: 10.1016/j.jinf.2024.106248. Epub 2024 Aug 29.
Evidence for the effect of favipiravir treatment of acute COVID-19 on recovery, hospital admissions and longer-term outcomes in community settings is limited.
In this multicentre. open-label, multi-arm, adaptive platform randomised controlled trial participants aged ≥18 years in the community with a positive test for SARS-CoV-2 and symptoms lasting ≤14 days were randomised to: usual care; usual care plus favipiravir tablets (loading dose of 3600 mg in divided doses on day one, then 800 mg twice a day for four days); or, usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery and hospitalisation/death related to COVID-19, within 28 days, analysed using Bayesian models. Recovery at six months was the primary longer-term outcome.
ISRCTN86534580.
The primary analysis model included 8811 SARS-CoV-2 positive mostly COVID vaccinated participants, randomised to favipiravir (n = 1829), usual care (n = 3256), and other treatments (n = 3726). Time to self-reported recovery was shorter in the favipiravir group than usual care (estimated hazard ratio 1·23 [95% credible interval 1·14 to 1·33]), a reduction of 2·98 days [1·99 to 3·94] from 16 days in median time to self-reported recovery for favipiravir versus usual care alone. COVID-19 related hospitalisations/deaths were similar (estimated odds ratio 0·99 [0·61 to 1·61]; estimated difference 0% [-0·9% to 0·6%]). 14 serious adverse events occurred in the favipiravir group and 4 in usual care. By six months, the proportion feeling fully recovered was 74·9% for favipiravir versus 71·3% for usual care (RR = 1·05, [1·02 to 1·08]).
In this open-label trial in a largely vaccinated population with COVID-19 in the community, favipiravir did not reduce hospital admissions, but shortened time to recovery and had a marginal positive impact on long term outcomes.
在社区环境中，有关法匹拉韦治疗急性 COVID-19 对康复、住院和长期结局影响的证据有限。
本研究是一项多中心、开放标签、多臂、自适应平台随机对照试验，参与者为社区中年龄≥18 岁、SARS-CoV-2 检测呈阳性且症状持续≤14 天的患者。将他们随机分配至以下三组：常规护理；常规护理+法匹拉韦片（第 1 天 3600mg 分剂量服用，随后 800mg 每日两次，连续 4 天）；或常规护理+其他干预措施。主要复合终点为 28 天内首次自我报告的康复时间和与 COVID-19 相关的住院/死亡，采用贝叶斯模型进行分析。康复至 6 个月是主要的长期结局。
ISRCTN86534580。
主要分析模型纳入了 8811 名 SARS-CoV-2 阳性且大多接种过 COVID 疫苗的患者，将其随机分配至法匹拉韦组（n=1829）、常规护理组（n=3256）和其他治疗组（n=3726）。与常规护理组相比，法匹拉韦组的自我报告康复时间更短（估计风险比 1.23[95%可信区间 1.14 至 1.33]），中位数时间从 16 天缩短至 13.02 天[1.99 至 3.94]。COVID-19 相关住院/死亡的发生率相似（估计比值比 0.99[0.61 至 1.61]；估计差异 0%[-0.9%至 0.6%]）。法匹拉韦组发生 14 例严重不良事件，常规护理组发生 4 例。在 6 个月时，法匹拉韦组完全康复的比例为 74.9%，常规护理组为 71.3%（RR=1.05[1.02 至 1.08]）。
在这项针对社区中 COVID-19 大流行中接种过疫苗的人群的开放标签试验中，法匹拉韦并未降低住院率，但缩短了康复时间，并对长期结局产生了一定的积极影响。
