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在 21 天内启动 COVID-19 单克隆抗体的比较有效性自适应平台试验。

Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days.

机构信息

Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

出版信息

Contemp Clin Trials. 2022 Feb;113:106652. doi: 10.1016/j.cct.2021.106652. Epub 2021 Dec 9.

Abstract

Outpatient treatments that limit progression to severe coronavirus disease 2019 (COVID-19) are of vital importance to optimise patient outcomes and public health. Monoclonal antibodies (mAb) demonstrated ability to decrease hospitalizations in randomized, clinical trials. However, there are many barriers to mAb treatment such as patient access and clinician education. There are no data comparing efficacy or safety of available mAbs. We sought to rapidly launch an adaptive platform trial with the goals of enhancing access to treatment, regardless of geography and socioeconomic status, and evaluating comparative efficacy and safety of available mAbs. Within 21 days from idea genesis, we allocated mAb treatment to all patients within the context of this clinical trial. Within 2 months, we closed the gap of the likelihood of receiving mAb, conditional on background positivity rate, between Black and White patients (Black patients 0.238; White patients 0.241). We describe trial infrastructure, lessons learned, and future directions for a culture of learning while doing.

摘要

门诊治疗对于限制严重 2019 冠状病毒病(COVID-19)的进展至关重要,能够优化患者的预后和公共卫生。单克隆抗体(mAb)在随机临床试验中显示出降低住院率的能力。然而,mAb 治疗存在许多障碍,例如患者获得治疗的机会和临床医生的教育。目前还没有比较可用 mAb 的疗效或安全性的数据。我们旨在通过以下目标快速启动一个适应性平台试验:增强治疗的可及性,无论地理位置和社会经济地位如何,并评估可用 mAb 的比较疗效和安全性。从创意诞生到 21 天内,我们根据该临床试验为所有患者分配 mAb 治疗。在 2 个月内,我们缩小了黑人患者和白人患者之间(黑人患者 0.238;白人患者 0.241)在接受 mAb 治疗的可能性方面的差距,这取决于背景阳性率。我们描述了试验基础设施、经验教训以及边做边学文化的未来方向。

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