Core Outcome Set for Traditional Chinese and Western Medicine Clinical Trials of COVID-19

Background: There are a large number of clinical trials for COVID-19. But the heterogeneity of outcomes may result in some clinical trials cannot be compared or merged. It is emergency to develop a core outcome set (COS) for clinical trials. Methods: A preliminary list of outcomes were developed after a systematic review of protocols of clinical trials for COVID-19. Then two rounds of Delphi survey was conducted. The stakeholders included traditional Chinese medicine (TCM) experts, Western medicine experts, nurses and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire with simple language. Frontline clinicians (including TCM and Western medicine clinicians), nurse, methodologist, evidence-based medicine researcher and staff from Chinese Clinical Trials Registry participate in video conference to vote. Results: 97 eligible study protocols were identified from 160 clinical trials. 76 outcomes were identified from TCM clinical trials, 126 outcomes were identified from Western medicine clinical trials. In the end, 145 were included in the first round of Delphi survey. In the end, a COS was developed for clinical trials of TCM and Western medicine was developed. The COS includes Clinical outcome (recovery/ improvement/ progression/ death), etiology (SARS-CoV-2 nucleic acid tests, viral load), inflammatory factor (CRP), vital signs (temperature, respiration), blood and lymphatic system outcomes (lymphocyte, virus antibody), respiratory outcomes (chest imaging, blood oxygen saturation, PaO2/FiO2, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (rate of preventing mild to moderate type patients from progressing to severe type), symptoms (clinical symptom score). The outcomes were recommended according to different types of disease. Outcome measurement instrument/definition were also recommended. Conclusion: A COS for COVID-19 may improve consistency of outcome reporting in clinical trials, which may help identify valued interventions after comparing different trials when the researchers report the same outcomes.