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调查长新冠治疗方法的注册临床试验:一项范围综述及研究建议

Registered clinical trials investigating treatment of long COVID: a scoping review and recommendations for research.

作者信息

Ceban Felicia, Leber Alexia, Jawad Muhammad Youshay, Yu Mathew, Lui Leanna M W, Subramaniapillai Mehala, Di Vincenzo Joshua D, Gill Hartej, Rodrigues Nelson B, Cao Bing, Lee Yena, Lin Kangguang, Mansur Rodrigo B, Ho Roger, Burke Matthew J, Rosenblat Joshua D, McIntyre Roger S

机构信息

Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Canada.

Brain and Cognition Discovery Foundation, Toronto, Canada.

出版信息

Infect Dis (Lond). 2022 Jul;54(7):467-477. doi: 10.1080/23744235.2022.2043560. Epub 2022 Mar 14.

Abstract

BACKGROUND

A considerable proportion of individuals report persistent, debilitating and disparate symptoms despite resolution of acute COVID-19 infection (i.e. long COVID). Numerous registered clinical trials investigating treatment of long COVID are expected to be completed in 2021-2022. The aim of this review is to provide a scope of the candidate treatments for long COVID. A synthesis of ongoing long COVID clinical trials can inform methodologic approaches for future studies and identify key research vistas.

METHODS

Scoping searches were conducted on multiple national and international clinical trial registries. Interventional trials testing treatments for long COVID were selected. The search timeline was from database inception to 28 July 2021.

RESULTS

This scoping review included 59 clinical trial registration records from 22 countries with a total projected enrolment of 6718. Considerable heterogeneity was exhibited amongst component records with respect to the characterization of long COVID (i.e. name, symptoms- including frequency, intensity, trajectory and duration- mode of ascertainment, and definition of acute phase). In addition, the majority of proposed interventions were non-pharmacological and either targeted multiple long COVID symptoms simultaneously, or focussed on treatment of respiratory/pulmonary sequelae. Multiple interventions targeted inflammation, as well as tissue oxygenation and cellular recovery, and several interventions were repurposed from analogous conditions.

CONCLUSIONS

The results of this scoping review investigating ongoing clinical trials testing candidate treatments for long COVID suggest that a greater degree of definitional stringency and homogeneity is needed insofar as the characterization of long COVID and inclusion/exclusion criteria.

摘要

背景

相当一部分人在急性新冠病毒感染(即新冠后症状)消退后仍报告有持续、使人衰弱且不同的症状。预计众多正在进行的关于新冠后症状治疗的注册临床试验将于2021 - 2022年完成。本综述的目的是提供新冠后症状候选治疗方法的范围。对正在进行的新冠后症状临床试验进行综合分析可为未来研究的方法学途径提供信息,并确定关键的研究方向。

方法

在多个国家和国际临床试验注册库中进行了范围界定检索。选取了测试新冠后症状治疗方法的干预性试验。检索时间范围是从数据库建立到2021年7月28日。

结果

本范围界定综述纳入了来自22个国家的59条临床试验注册记录,预计总入组人数为6718人。各组成记录在新冠后症状的特征描述(即名称、症状——包括频率、强度、变化轨迹和持续时间——确定方式以及急性期定义)方面表现出相当大的异质性。此外,大多数提议的干预措施是非药物性的,要么同时针对多种新冠后症状,要么专注于呼吸/肺部后遗症的治疗。多种干预措施针对炎症以及组织氧合和细胞恢复,还有几种干预措施是从类似病症中重新调整用途的。

结论

本次对正在进行的测试新冠后症状候选治疗方法的临床试验进行范围界定综述的结果表明,就新冠后症状的特征描述以及纳入/排除标准而言,需要更高程度的定义严格性和同质性。

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