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

Autor: Deepak L. Bhatt, Musa A. Sharkawi, Mandeep R. Mehra, W. Schuyler Jones, Muthiah Vaduganathan, Manesh R. Patel, Alexander J Blood, David E. Wang, Peter Monteleone, Ajar Kochar, Renato D. Lopes, Anubodh S. Varshney, Hasan K. Siddiqi, Ankeet S. Bhatt
Rok vydání: 2021
Předmět:
medicine.medical_specialty
Databases
Factual
Cross-sectional study
Vasodilator Agents
medicine.medical_treatment
MEDLINE
Disease
030204 cardiovascular system & hematology
Defibrotide
Single Center
Renin-Angiotensin System
03 medical and health sciences
Extracorporeal Membrane Oxygenation
0302 clinical medicine
Fibrinolytic Agents
Internal medicine
Extracorporeal membrane oxygenation
medicine
Humans
Hypoglycemic Agents
Registries
Article Type: Original Investigation
030212 general & internal medicine
Randomized Controlled Trials as Topic
Clinical Trials as Topic
National Library of Medicine (U.S.)
SARS-CoV-2
business.industry
COVID-19
Cardiovascular Agents
Combined Modality Therapy
United States
COVID-19 Drug Treatment
Clinical trial
Treatment Outcome
Cardiovascular Diseases
Cohort
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Patient Participation
Colchicine
Cardiology and Cardiovascular Medicine
business
medicine.drug
Zdroj: American Heart Journal
ISSN: 0002-8703
DOI: 10.1016/j.ahj.2020.10.065
Popis: Background 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. Methods 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. Results 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). Conclusions 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.
Databáze: OpenAIRE
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