Abstract Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.

中文翻译：

---

2019 年冠状病毒病 (COS-COVID) 临床试验的核心结果集

摘要 自 2019 年 12 月爆发以来，已注册或开展了一系列针对 2019 冠状病毒病（COVID-19）的临床试验。然而，此类试验的显着异质性和不太重要的结果可能会导致研究资源的浪费。本研究旨在为 COVID-19 的临床试验开发一个核心结果集 (COS)，以解决结果问题。该研究是根据有效性试验中的核心结果指标 (COMET) 手册（1.0 版）进行的，该手册是 COS 开发指南。成立了一个研究小组，除医学期刊编辑外，还包括呼吸和危重症医学、中医、循证医学、临床药理学和统计学方面的专家。临床试验注册网站（chictr.org.cn 和临床试验。gov) 被搜索以检索临床试验协议和结果，以形成结果池。共纳入了 78 项关于 COVID-19 的临床试验方案，并收集了 259 项结果。标准化后，在七个不同类别中确定了 132 项结果，其中 58 项被选中制定初步结果列表以进一步达成共识。经过两轮德尔福调查和一次共识会议，确定了 COVID-19 不同临床分类的最重要结果，并确定构成 COVID-19 临床试验的 COS（COS-COVID）。COS-COVID 包括轻度类型的一个结果（到 2019-nCoV 逆转录聚合酶链反应 (RT-PCR) 阴性的时间），普通类型的四个结果（住院时间、复合事件、临床症状评分、2019-nCoV RT-PCR 阴性的时间）、严重类型的五个结果（复合事件、住院时间、动脉氧分压 (PaO2)/吸入氧分数 (FiO2)、持续时间）机械通气，以及到 2019-nCoV RT-PCR 阴性的时间）、危重类型的一项结果（全因死亡率）和康复期的一项结果（肺功能）。COS-COVID 是目前评价干预效果最有价值、最实用的临床结果集，对证据评估和决策有用。随着对 COVID-19 的深入了解和应用反馈，COS-COVID 应不断更新。动脉氧分压 (PaO2)/吸入氧浓度 (FiO2)、机械通气持续时间和到 2019-nCoV RT-PCR 阴性的时间）、一种危重型结果（全因死亡率）和一种康复结果期间（肺功能）。COS-COVID 是目前评价干预效果最有价值、最实用的临床结果集，对证据评估和决策有用。随着对 COVID-19 的深入了解和应用反馈，COS-COVID 应不断更新。动脉氧分压 (PaO2)/吸入氧浓度 (FiO2)、机械通气持续时间和至 2019-nCoV RT-PCR 阴性的时间）、一项危重类型结果（全因死亡率）和一项康复结果期间（肺功能）。COS-COVID是目前评价干预效果最有价值、最实用的临床结果集，对证据评估和决策有用。随着对 COVID-19 的深入了解和应用反馈，COS-COVID 应不断更新。COS-COVID 是目前评价干预效果最有价值、最实用的临床结果集，对证据评估和决策有用。随着对 COVID-19 的深入了解和应用反馈，COS-COVID 应不断更新。COS-COVID 是目前评价干预效果最有价值、最实用的临床结果集，对证据评估和决策有用。随着对 COVID-19 的深入了解和应用反馈，COS-COVID 应不断更新。