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Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes 期刊论文

编号：

57D6A69F1CF18B429C739B2288D2F17F
作者：

Hayward, Gail^[1]Yu, LyMee^[1]Little, Paul^[2]Gbinigie, Oghenekome^[1];Shanyinde, Milensu^[1];Harris, Victoria^[1];Dorward, Jienchi^[1,3]Saville, Benjamin R.^[4,5]Berry, Nicholas^[4];Evans, Philip H.^[6,7];Thomas, Nicholas P. B.^[7];Patel, Mahendra G.^[1];Richards, Duncan^[8,9];Hecke, Oliver V.^[1];Detry, Michelle A.^[4];Saunders, Christina^[4];Fitzgerald, Mark^[4];Robinson, Jared^[1];LatimerBell, Charlotte^[1];Allen, Julie^[1];Ogburn, Emma^[1];Grabey, Jenna^[1];de Lusignan, Simon^[1]Hobbs, F. D. Richard^[1]Butler, Christopher C.^[1]
语种：

英文
期刊：

JOURNAL OF INFECTION ISSN：0163-4453 2024 年 88 卷 4 期 ; APR
疾病分类：

新型冠状病毒肺炎
关键词：

SARS-Cov2 COVID-19 Ivermectin Clinical trial Long-term follow up
摘要：

Background: The evidence for whether ivermectin impacts recovery, hospital admissions, and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in the context of clinical trials. Methods: In this multicentre, open-label, multi-arm, adaptive platform randomised controlled trial, we included participants aged >= 18 years in the community, with a positive SARS-CoV-2 test, and symptoms lasting <= 14 days. Participants were randomised to usual care, usual care plus ivermectin tablets (target 300-400 mu g/kg per dose, once daily for 3 days), or usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery, and COVID-19 related hospitalisation/death within 28 days, analysed using Bayesian models. Recovery at 6 months was the primary, longer term outcome. Trial registration: ISRCTN86534580. Findings: The primary analysis included 8811 SARS-CoV-2 positive participants (median symptom duration 5 days), randomised to ivermectin (n = 2157), usual care (n = 3256), and other treatments (n = 3398) from June 23, 2021 to July 1, 2022. Time to self-reported recovery was shorter in the ivermectin group compared with usual care (hazard ratio 115 [95% Bayesian credible interval, 107 to 123], median decrease 2.06 days [100 to 306]), probability of meaningful effect (pre-specified hazard ratio >= 1.2) 0192). COVID-19-related hospitalisations/deaths (odds ratio 102 [063 to 162]; estimated percentage difference 0% [-1% to 06%]), serious adverse events (three and five respectively), and the proportion feeling fully recovered were similar in both groups at 6 months (743% and 712% respectively (RR = 105, [102 to 108]) and also at 3 and 12 months. Interpretation: Ivermectin for COVID-19 is unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer -term outcomes. Further trials of ivermectin for SARS-Cov-2 infection in vaccinated community populations appear unwarranted. Funding: UKRI/National Institute of Health Research (MC_PC_19079). (c) 2024 The Author(s). Published by Elsevier Ltd on behalf of The British Infection Association. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
推荐引用方式
GB/T 7714：

Hayward Gail,Yu Ly-Mee,Little Paul, et al. Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes [J].JOURNAL OF INFECTION,2024,88(4).
APA：

Hayward Gail,Yu Ly-Mee,Little Paul,Gbinigie Oghenekome,&Butler Christopher C..(2024).Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes .JOURNAL OF INFECTION,88(4).
MLA：

Hayward Gail, et al. "Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes" .JOURNAL OF INFECTION 88,4(2024).
数据来源自科睿唯安Web of Science核心合集
入库时间：

2024/6/5 17:52:19
更新时间：

2024/6/5 17:52:19

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