von Falkenhausen Aenne S, Geipel Scott, Gail Antonia, Scherer Clemens, Stockhausen Sven, Sams Lauren E, Becker Finn, Doldi Philipp M, Lemmermöhle Eric, de Villèle Paul, Schleef Michael, Becker Marc, Lauterbach Moritz, Massberg Steffen, Kääb Stefan, Sinner Moritz F
Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
German Centre for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany.
ERJ Open Res. 2024 Aug 12;10(4). doi: 10.1183/23120541.00277-2024. eCollection 2024 Jul.
COVID-19 remains a challenge to individual health and healthcare resources worldwide. Telemedical surveillance might minimise hospitalisation and direct patient-physician contacts. Yet, randomised clinical trials evaluating telemedical management of COVID-19 patients are lacking.
COVID-SMART is a randomised, open-label, controlled clinical trial investigating whether telemedicine reduces the primary end-point of hospitalisation or any unscheduled utilisation of an emergency medical service within 30 days of follow-up. Key secondary end-points included mortality and primary end-point components. We enrolled acutely infected SARS-CoV-2 patients suitable for outpatient care. All presented with ≥1 risk factor for an adverse COVID-19 course. Patients were randomised 1:1 into a control group receiving standard of care and an intervention group receiving smartphone-based assessment of oxygen saturation, heart rate and electrocardiogram, and telemedical counselling a 24/7 emergency hotline.
Of 607 enrolled patients (mean±sd age 46.7±13.5 years), 304 were randomised into the intervention and 303 into the control group. The primary end-point occurred in 6.9% (n=21) of the intervention and in 9.6% (n=29) of the control group (hazard ratio (HR) 0.72, 95% confidence interval (CI) 0.41-1.26; p=0.24). No deaths occurred during follow-up. Fewer intervention group participants utilised outpatient-based emergency medical services (HR 0.43, 95% CI 0.20-0.90; p=0.03).
COVID-SMART is the first randomised clinical trial assessing the benefit of telemedicine in an acute respiratory infectious disease. Whereas telemedical management did not reduce the primary end-point of hospitalisation, fewer intervention group patients used outpatient-based emergency services, suggesting a potential benefit for less-acutely infected individuals.
新型冠状病毒肺炎（COVID-19）仍然对全球个人健康和医疗资源构成挑战。远程医疗监测可能会减少住院率并减少患者与医生的直接接触。然而，目前尚缺乏评估COVID-19患者远程医疗管理的随机临床试验。
COVID-SMART是一项随机、开放标签、对照临床试验，旨在研究远程医疗是否能降低随访30天内的主要终点——住院率或急诊医疗服务的任何非计划使用情况。关键次要终点包括死亡率和主要终点组成部分。我们纳入了适合门诊治疗的急性感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）患者。所有患者均具有≥1个COVID-19不良病程风险因素。患者按1:1随机分为接受标准治疗的对照组和接受基于智能手机的血氧饱和度、心率和心电图评估以及远程医疗咨询（24/7紧急热线）的干预组。
在607名纳入患者中（平均±标准差年龄46.7±13.5岁），304名被随机分配到干预组，303名被随机分配到对照组。主要终点在干预组的发生率为6.9%（n = 21），在对照组为9.6%（n = 29）（风险比（HR）0.72，95%置信区间（CI）0.41 - 1.26；p = 0.24）。随访期间无死亡发生。干预组使用门诊急诊医疗服务的参与者较少（HR 0.43，95% CI 0.20 - 0.90；p = 0.03）。
COVID-SMART是第一项评估远程医疗在急性呼吸道传染病中益处的随机临床试验。虽然远程医疗管理并未降低住院这一主要终点，但干预组使用门诊急诊服务的患者较少，这表明对感染程度较轻的个体可能有潜在益处。
