Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis

• Published in: The American heart journal 2021-02, Vol.232, p.105-115
• Main Authors: Varshney, Anubodh S., Wang, David E., Bhatt, Ankeet S., Blood, Alexander, Sharkawi, Musa A., Siddiqi, Hasan K., Vaduganathan, Muthiah, Monteleone, Peter P., Patel, Manesh R., Jones, W. Schuyler, Lopes, Renato D., Mehra, Mandeep R., Bhatt, Deepak L., Kochar, Ajar
• Format: Article
• Language: English
• Subjects: Aldosterone; Angiotensin; Antiinfectives and antibacterials; Cardiovascular Agents - therapeutic use; Cardiovascular disease; Cardiovascular Diseases - complications; Cardiovascular Diseases - drug therapy; Cardiovascular Diseases - mortality; Clinical outcomes; Clinical trials; Clinical Trials as Topic - statistics & numerical data; Colchicine; Colchicine - therapeutic use; Combined Modality Therapy - statistics & numerical data; Coronaviruses; Corporate sponsorship; COVID-19; COVID-19 - complications; COVID-19 - mortality; COVID-19 Drug Treatment; Cross-sectional studies; Databases, Factual - statistics & numerical data; Drug development; Enrollments; Extracorporeal Membrane Oxygenation - statistics & numerical data; Fibrinolytic Agents - therapeutic use; Health policy; Health risks; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypoglycemic Agents - therapeutic use; Inflammation; Microorganisms; Morbidity; Mortality; National Library of Medicine (U.S.); Original Investigation; Oxygenation; Pathogenesis; Patient Participation - statistics & numerical data; Patients; Population studies; Randomized Controlled Trials as Topic - statistics & numerical data; Registries - statistics & numerical data; Renin; Renin-Angiotensin System; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Treatment Outcome; United States; Vasodilator Agents - therapeutic use; Vasodilators; Viral diseases
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2020.10.065

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 clin