Please use this identifier to cite or link to this item:
Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)
Jin, X
Pang, B
Zhang, J
Liu, Q
Yang, Z
Feng, J
Liu, X
Zhang, L
Wang, B
Huang, Y
Josephine Fauci, A
Ma, Y
Soo Lee, M
Yuan, W
Xie, Y
Tang, J
Gao, R
Du, L
Zhang, S
Qi, H
Sun, Y
Zheng, W
Yang, F
Chua, H
Wang, K
Ou, Y
Huang, M
Zhu, Y
Yu, J
Tian, J
Zhao, M
Hu, J
Yao, C
Li, Y
Zhang, B
Acceso Abierto
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 ( and 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 (PaO 2 )/fraction of inspired oxygen (FiO 2 ), 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.
Engineering (Beijing)
Appears in Collections:Artículos científicos

Upload archives

File SizeFormat 
102721.pdf354.08 kBAdobe PDFView/Open