COVID-19: multi-arm, multi stage adaptive clinical trial (CoV-MAMS)

COVID-19：多组、多阶段适应性临床试验（CoV-MAMS）

• 批准号: MC_PC_19056
• 负责人: Peter Horby
• 金额: $ 268.35万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MC_PC_19056
• 关键词: COVID; 19; multi; arm; stage

The coronavirus epidemic is a global health emergency. The infection can, in a minority of cases, cause serious lung disease requiring hospital-care and even death. Whilst general hospital care can improve patients’ recovery, there are currently no specific medicines for this infection. The best way to prove that medicines are effective and safe is through clinical trials which compare the new medicine against normal care. Clinical trials of two of the most promising medicines have already enrolled patients in China. There are, however, many other medicines that have been proposed for the treatment of patients with the novel coronavirus. We will start a new trial in the UK to test up to four additional medicines. Patients hospitalised with confirmed coronavirus infection will be invited to join the trial and we will assess whether the new medicines are safe and can improve patients’ recovery.We will use a flexible design that allows us to add new medicines as they become available. The trial will start by testing two medicine, a drug that may slow down the replication of the virus and a drug that may reduce the inflammation associated with the infection. Other medicines will be added when they become available.

冠状病毒疫情是全球卫生紧急情况。在少数情况下，这种感染会导致严重的肺部疾病，需要住院治疗，甚至死亡。虽然一般的医院护理可以改善患者的康复，但目前还没有针对这种感染的特效药。证明药物有效和安全的最佳方法是通过临床试验，将新药与常规护理进行比较。两种最有前途的药物的临床试验已经在中国招募了患者。然而，还有许多其他药物已被提议用于治疗新型冠状病毒患者。我们将在英国开始一项新的试验，测试多达四种其他药物。我们会邀请确诊感染冠状病毒而住院的病人参与试验，并会评估新药是否安全，以及能否改善病人的康复情况。我们会采用灵活的设计，让我们可以在有新药供应时增加新药。该试验将首先测试两种药物，一种可能减缓病毒复制的药物和一种可能减少与感染相关的炎症的药物。其他药物将在可用时添加。

项目成果

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

恩格列净治疗 COVID-19 入院患者（恢复）：一项随机、对照、开放标签平台试验

• DOI: 10.1101/2023.04.13.23288469
• 发表时间: 2023
• 作者: Horby P

Hydroxychloroquine for COVID-19: Balancing contrasting claims.

• DOI: 10.1016/j.ejim.2020.11.018
• 发表时间: 2020-12
• 期刊: European journal of internal medicine
• 影响因子: 8
• 作者: Horby PW;Emberson JR
• 通讯作者: Emberson JR

Evaluation of the Efficacy and Safety of Intravenous Remdesivir in Adult Patients with Severe Pneumonia caused by COVID-19 virus Infection: study protocol for a Phase 3 Randomized, Double-blind, Placebo-controlled, Multicentre trial

静脉注射瑞德西韦对 COVID-19 病毒感染引起的重症肺炎成人患者的疗效和安全性评估：3 期随机、双盲、安慰剂对照、多中心试验的研究方案

• DOI: 10.21203/rs.2.24058/v2
• 发表时间: 2020
• 作者: Horby P

Toward Consensus on Correct Interpretation of Protein Binding in Plasma and Other Biological Matrices for COVID-19 Therapeutic Development.

• DOI: 10.1002/cpt.2099
• 发表时间: 2021-07
• 期刊: Clinical pharmacology and therapeutics
• 影响因子: 6.7
• 作者: Boffito M;Back DJ;Flexner C;Sjö P;Blaschke TF;Horby PW;Cattaneo D;Acosta EP;Anderson P;Owen A
• 通讯作者: Owen A