Rigshospitalet, Centre of Excellence for Health, Immunity, and Infections (CHIP ), Copenhagen, Denmark.
Department of Infectious Diseases, Nordsjællands Hospital, Hillerød, Denmark.
Clin Infect Dis. 2023 Feb 8;76(3):e82-e89. doi: 10.1093/cid/ciac639.
Many interventional in-patient coronavirus disease 2019 (COVID-19) trials assess primary outcomes through day 28 post-randomization. Since a proportion of patients experience protracted disease or relapse, such follow-up period may not fully capture the course of the disease, even when randomization occurs a few days after hospitalization.
Among adults hospitalized with COVID-19 in eastern Denmark from 18 March 2020-12 January 2021 we assessed all-cause mortality, recovery, and sustained recovery 90 days after admission, and readmission and all-cause mortality 90 days after discharge. Recovery was defined as hospital discharge and sustained recovery as recovery and alive without readmissions for 14 consecutive days.
Among 3386 patients included in the study, 2796 (82.6%) reached recovery and 2600 (77.0%) achieved sustained recovery. Of those discharged from hospital, 556 (19.9%) were readmitted and 289 (10.3%) died. Overall, the median time to recovery was 6 days (interquartile range [IQR]: 3-10), and 19 days (IQR: 11-33) among patients in intensive care in the first 2 days of admission.
Postdischarge readmission and mortality rates were substantial. Therefore, sustained recovery should be favored to recovery outcomes in clinical COVID-19 trials. A 28-day follow-up period may be too short for the critically ill.
许多针对住院的 2019 年冠状病毒病(COVID-19)的干预试验通过随机分组后 28 天评估主要结局。由于一部分患者的疾病持续时间较长或复发,因此即使随机分组发生在住院后几天,这种随访期也可能无法完全捕捉疾病的过程。
在 2020 年 3 月 18 日至 2021 年 1 月 12 日期间,丹麦东部住院治疗的 COVID-19 成年患者中,我们评估了入院后 90 天的全因死亡率、恢复和持续恢复,以及出院后 90 天的再入院和全因死亡率。恢复定义为出院,持续恢复定义为连续 14 天无再入院且存活。
在研究纳入的 3386 例患者中,2796 例(82.6%)达到了恢复,2600 例(77.0%)实现了持续恢复。出院患者中,有 556 例(19.9%)再次入院,289 例(10.3%)死亡。总体而言,恢复的中位时间为 6 天(四分位距[IQR]:3-10),而在入院前两天入住重症监护病房的患者中为 19 天(IQR:11-33)。
出院后再入院和死亡率仍然较高。因此,在 COVID-19 临床试验中,应优先考虑持续恢复而不是恢复结局。28 天的随访期对于重症患者可能太短。