AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter.
AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter.
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DOI：
10.1186/s13063-021-05458-4
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发表时间：
2021-07-26
期刊：
影响因子：
2.5
通讯作者：
AGILE investigators
中科院分区：
文献类型：
--
作者：
Griffiths GO;FitzGerald R;Jaki T;Corkhill A;Reynolds H;Ewings S;Condie S;Tilt E;Johnson L;Radford M;Simpson C;Saunders G;Yeats S;Mozgunov P;Tansley-Hancock O;Martin K;Downs N;Eberhart I;Martin JWB;Goncalves C;Song A;Fletcher T;Byrne K;Lalloo DG;Owen A;Jacobs M;Walker L;Lyon R;Woods C;Gibney J;Chiong J;Chandiwana N;Jacob S;Lamorde M;Orrell C;Pirmohamed M;Khoo S;AGILE investigators
对于鉴定用于治疗COVID-19的新型疗法存在迫切的未满足的临床需求。已经开发了许多COVID-19后期试验平台，以在英国和全球范围内研究（通常重新使用）药物（例如，牛津大学领导的RECOVERY和世卫组织领导的SOLIDARITY）。迫切需要在早期阶段试验平台内研究新的候选物，从而有希望的候选物可以进入已建立的后期平台。AGILE从英国范围内的合作发展而来，对SARS-CoV-2感染的候选人进行早期临床评估，以加速国家和全球医疗干预。AGILE是一项无缝的I/IIa期平台研究，旨在确定最佳剂量，确定每种候选药物的活性和安全性，并建议是否应对其进行进一步评估。每种候选药物在其自身的试验中进行评价，无论是作为开放标签单臂健康志愿者研究还是在患者中进行，通常以2：1的比例在候选药物和对照药物之间进行随机分配，以支持候选药物。通常在6名患者的队列中顺序评估每个剂量的安全性。一旦确定了II期剂量，通过无缝扩展到更大的队列来评估疗效。AGILE是完全灵活的，因为主方案中的核心设计可以根据候选人的先验知识适用于每个候选人（即，可以修改人群、主要终点和样本量）。该信息在主方案的每个候选特定试验方案中进行了详细说明。很少有获批的COVID-19治疗方法可用，如地塞米松、瑞德西韦和托珠单抗用于住院患者。AGILE平台旨在快速识别新的有效和安全的治疗方法，以帮助结束当前的全球COVID-19大流行。目前，我们在该平台研究中有三项候选特定试验正在开放招募。EudraCT编号：2020-001860-27 2020年3月14日ClinicalTrials.gov标识符：NCT 04746183 2021年2月19日ISRCTN参考号：27106947在线版本包含补充材料，可通过10.1186/s13063-021-05458-4获得。
There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183 19 February 2021 ISRCTN reference: 27106947 The online version contains supplementary material available at 10.1186/s13063-021-05458-4.
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影响因子：
64.8
作者：
Bournazos S;Corti D;Virgin HW;Ravetch JV
通讯作者：
Ravetch JV
影响因子：
3.4
作者：
Rajoli RKR;Pertinez H;Arshad U;Box H;Tatham L;Curley P;Neary M;Sharp J;Liptrott NJ;Valentijn A;David C;Rannard SP;Aljayyoussi G;Pennington SH;Hill A;Boffito M;Ward SA;Khoo SH;Bray PG;O'Neill PM;Hong WD;Biagini GA;Owen A
通讯作者：
Owen A
DOI：
10.1016/s0140-6736(21)00298-1
发表时间：
2021-02-06
期刊：
Lancet (London, England)
影响因子：
--
作者：
Burki T
通讯作者：
Burki T
中国武汉市 138 例 2019 新型冠状病毒感染肺炎住院患者的临床特征。
影响因子：
120.7
作者：
Wang, Dawei;Hu, Bo;Peng, Zhiyong
通讯作者：
Peng, Zhiyong
影响因子：
5.4
作者：
Agostini, Maria L.;Pruijssers, Andrea J.;Denison, Mark R.
通讯作者：
Denison, Mark R.