Branch Andrea D
Division of Liver Diseases Department of Medicine Icahn School of Medicine at Mount Sinai New York NY.
Hepatol Commun. 2020 Nov 5;4(12):1864-1879. doi: 10.1002/hep4.1588. eCollection 2020 Dec.
Coronavirus disease 2019 (COVID-19) has created an emergency of epic proportions. While a vaccine may be forthcoming, this is not guaranteed, as discussed herein. The potential problems and ominous signs include (1) lung injury that developed in animals given an experimental vaccine for the severe acute respiratory syndrome coronavirus (SARS-CoV)-1; (2) a perversion of adaptive immune responses called antibody-dependent enhancement of infection that occurs in SARS-CoV-1 and that may occur in people vaccinated for COVID-19; (3) the frequent and recurrent infections that are caused by respiratory coronaviruses; and (4) the appearance of mutations in SARS-CoV-2 proteins, which raise the specter of vaccine escape mutants. Because success is uncertain, alternatives to vaccines need to be vigorously pursued during this critical moment in the pandemic. Alternatives include (1) engineered monoclonal antibodies that do not cause antibody-dependent enhancement; (2) cocktails of antiviral drugs and inhibitors of the cellular proteins required for SARS-CoV-2 replication; (3) interferons; and (4) anticoagulants, antioxidants, and immune modulators. To organize and coordinate the systematic investigation of existing therapies and new therapies (as they emerge), a Covid-19 clinical trials network is needed to provide (1) robust funding (on a par with vaccine funding) and administration; (2) an adaptive trial design committee to prioritize interventions and review results in real time; (3) a computer interface to facilitate patient enrollment, make data available to investigators, and present findings; (4) a practice guidelines study group; and (5) a mobile corps of COVID-19 experts available for rapid deployment, to assist local health care providers and enroll patients in trials as outbreaks occur. To combat the COVID-19 pandemic and future mass contagions, the network would be a cornerstone of a comprehensive infectious diseases research program.
2019冠状病毒病(COVID-19)已引发一场规模空前的紧急情况。虽然可能会有疫苗问世,但如本文所述,这并无保证。潜在问题和不祥迹象包括:(1)在给动物接种针对严重急性呼吸综合征冠状病毒(SARS-CoV)-1的实验性疫苗后出现的肺损伤;(2)在SARS-CoV-1中出现的一种被称为抗体依赖增强感染的适应性免疫反应异常,可能在接种COVID-19疫苗的人群中发生;(3)呼吸道冠状病毒引起的频繁反复感染;(4)SARS-CoV-2蛋白中出现的突变,这引发了疫苗逃逸突变体的幽灵。由于成功与否不确定,在疫情的这一关键时刻,需要大力寻求疫苗的替代方案。替代方案包括:(1)不会引起抗体依赖增强的工程单克隆抗体;(2)抗病毒药物和SARS-CoV-2复制所需细胞蛋白抑制剂的组合;(3)干扰素;(4)抗凝剂、抗氧化剂和免疫调节剂。为了组织和协调对现有疗法和新出现疗法的系统研究,需要一个COVID-19临床试验网络来提供:(1)充足的资金(与疫苗资金相当)和管理;(2)一个适应性试验设计委员会,以便对干预措施进行优先排序并实时审查结果;(3)一个计算机接口,以方便患者入组、向研究人员提供数据并展示研究结果;(4)一个实践指南研究小组;(5)一支可快速部署的COVID-19专家流动队伍,以协助当地医疗保健提供者并在疫情爆发时让患者参加试验。为了抗击COVID-19疫情和未来的大规模传染病,该网络将成为全面传染病研究计划的基石。