For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period:
那個在巴西進行,全部參與者都是醫護人員的臨床實驗,科興的protocol裡case的定義 3.16.7 是基本上follow FDA guideline。
來自與科興合作的巴西大學發表的資料(有葡萄牙語以及英語版本)
3.16.7 COVID-19 CASE DEFINITIONS
The definition of case caused by the 2019 SARS-CoV-2 (COVID-19) that will be used in this study will be that stated by the FDA guides [26], as follows:
Anyone who has at least one of the following symptoms for two days or more should be tested to detect SARS-CoV-2 nucleic acid in a clinical sample: