Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA.
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Am Heart J. 2021 Feb;232:105-115. doi: 10.1016/j.ahj.2020.10.065. Epub 2020 Oct 26.
Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described.
ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries.
A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41).
A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.
描述在 ClinicalTrials.gov 上注册的与 COVID-19 相关的心血管治疗临床试验的特征。
于 2020 年 8 月 7 日在 ClinicalTrials.gov 上查询与 COVID-19 相关的试验。纳入评估已确立的心血管药物、其他纤维蛋白溶解剂（defibrotide）和体外膜氧合的研究。排除评估抗微生物、恢复期血浆、非秋水仙碱抗炎药和其他治疗的研究。从研究特定条目表列出试验特征。
截至 2020 年 8 月 7 日，与 COVID-19 相关的研究共有 2935 项在 ClinicalTrials.gov 上注册。其中，1645 项为干预性研究，最终分析队列包括 114 项评估 10 种心血管治疗类别的研究。抗血栓形成药（32.5%；n = 37）最常被评估，其次是肺血管扩张剂（14.0%；n = 16）、肾素-血管紧张素-醛固酮系统相关治疗（12.3%；n = 14）和秋水仙碱（8.8%；n = 10）。评估多种心血管治疗类别和心血管治疗与非心血管治疗联合的试验分别占 4.4%（n = 5）和 9.6%（n = 11）。大多数研究为随机分配设计（87.7%；n = 100）、纳入少于 1000 名参与者（86.8%；n = 99）、单一地点实施（55.3%；n = 63），且主要结局为死亡率或死亡率为主要终点的复合终点（56.1%；n = 64）。大多数研究人群为 COVID-19 住院患者（81.6%；n = 93）。在数据库查询时，28.9%（n = 33）的研究尚未招募，且大多数预计在 2020 年 12 月后完成（67.8%；n = 78）。大多数主要赞助商位于北美（43.9%；n = 50）或欧洲（36.0%；n = 41）。
ClinicalTrials.gov 上注册的与 COVID-19 相关的临床试验中，仅有 7%计划评估心血管治疗。在心血管治疗研究中，大多数计划为单中心、纳入少于 1000 名住院患者、由欧洲或北美学术机构赞助、并预计在 2020 年 12 月后完成。总体而言，这些发现强调需要建立一个具有平台方案的网站网络，以便快速评估多种疗法，并推广至一般人群，从而为 COVID-19 患者提供未来的临床治疗和卫生政策信息。
