Clinic of Infectious Diseases, HUB-Erasme Hospital, Université Libre de Bruxelles, 1070 Brussels, Belgium.
Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, 1070 Brussels, Belgium.
Viruses. 2022 Jun 29;14(7):1427. doi: 10.3390/v14071427.
Belgium has actively participated in clinical research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) since the beginning of the pandemic to help identify effective and safe treatments for COVID-19. The objective of this review is to provide a picture of the clinical studies carried out in hospitalized patients with COVID-19 in Belgium. We collected data on all randomized, interventional trials in patients with COVID-19 that were registered on two recognized clinical trial registers, started enrollment before 31 December 2021, and included at least one patient in a Belgian center. Data were collected concerning the therapies investigated and the nature of the trials performed. Thirty-three hospitals (32% of all Belgian hospitals) participated in at least one of 28 trials (13 sponsored by the industry and 15 by academic centers) on therapeutics for COVID-19 in hospitalized patients: 7 (25%) evaluated antivirals, 17 (61%) immunomodulators, 2 (7%) anti-coagulants, and 1 (3%) nitric oxide to improve respiratory function. Nineteen (68%) were phase II trials. Only three (11%) of the trials were international platform trials. Despite numerous trials, less than 3% of all Belgian patients hospitalized with COVID-19 participated in a clinical trial on therapeutics. As in many other countries, more efforts could have been made to avoid running small, under-powered, mono- or bicenter trials, to create better collaboration between the different Belgian hospitals, and to participate in more international clinical trials, and more specifically in adaptive, platform trials.
比利时从大流行开始就积极参与严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的临床研究,以帮助确定 COVID-19 的有效和安全治疗方法。本综述的目的是提供在比利时住院 COVID-19 患者中进行的临床研究情况。我们收集了在两个公认的临床试验注册中心注册的所有 COVID-19 患者的随机、干预性临床试验的数据,这些试验在 2021 年 12 月 31 日之前开始入组,并且至少有一名患者在比利时中心。收集了有关所研究的治疗方法和所进行的试验类型的数据。33 家医院(所有比利时医院的 32%)参与了 28 项针对住院 COVID-19 患者的治疗方法的试验中的至少一项:7 项(25%)评估了抗病毒药物,17 项(61%)评估了免疫调节剂,2 项(7%)评估了抗凝药物,1 项(3%)评估了一氧化氮以改善呼吸功能。19 项(68%)为 II 期试验。只有 3 项(11%)试验为国际平台试验。尽管进行了多项试验,但在 COVID-19 住院患者中,只有不到 3%的患者参与了治疗方法的临床试验。与许多其他国家一样,本可以做出更多努力来避免开展小型、效能不足、单一或双中心试验,在不同的比利时医院之间建立更好的合作,并参与更多的国际临床试验,特别是适应性、平台试验。