COVID-19 and the cardiovascular system: A systematic review of the clinical trial landscape

Abstract

Background: At the end of 2019, a novel coronavirus was identified as the cause of a cluster of pneumonia cases in Wuhan, China. Due to its high rate of interpersonal transmission the disease rapidly spread in China resulting in an epidemic and subsequently a pandemic with severe impact on social, economic and medical systems globally. Our understanding of the SARS-CoV-2 virus and its effects on the human body continues to evolve as new information becomes available. This paper is an overview of ongoing clinical trials registered with ClinicalTrials.gov on August 3, 2020 to guide future research and clinical practice. Our objective is to do a systematic review of the existing trials registered with ClinicalTrials.gov related to COVID-19 and the cardiovascular (CV) system. The aim of this is to describe the ongoing research in order to guide future practice and evaluate areas of deficiencies. Methods: We conducted our search on ClinicalTrials.gov (https://clinicaltrials.gov/) on August 3, 2020 and used the key terms “COVID-19” and “cardiovascular. An independent two-person review was carried out for exclusion criteria. Exclusion criteria was defined as studies that were terminated, withdrawn, suspended, of unknown status, or had no connection to the CV system. Three duplicate studies were removed; 141 studies were removed after an independent two person review determined that it did not hold any relevant connection to the CV system and two studies were removed from the data as they were withdrawn and suspended respectively. There were no conflicting opinions between the two researchers regarding the 141 clinical trials excluded. The remaining 122 studies included were then grouped together based on their primary and secondary objectives. The trial was conducted in accordance with the Declaration of Helsinki. No experiments involving humans were done by the researchers and therefore ethical approval was not required. Results: We found 122 studies applicable to our search criteria and then grouped them together based on topics of investigation as identified by primary and secondary objectives. The identified studies varied from observational, registry based and interventional with most of them falling into the first two categories. The studies were ongoing at that point and did not have results to report or analyze. Conclusions: Our search on ClinicalTrials.gov produced a variety of studies that investigate relationships between COVID-19 and the CV system. Our search identified the main areas with ongoing research that has the ability to resolve controversies regarding current management of patients with COVID-19 including the ideal thromboprophylaxis regimen; arrhythmogenic potential of patients with COVID-19 and appropriate monitoring of these patients and long term morbidity related to COVID-19 and the CV system. The key finding of our analysis is that the majority of the ongoing studies are observational in nature and not randomized controlled trials. Review of these ongoing studies can aid medical professionals and researchers in outlining current areas of clinical equipoise and help with planning prospective research study topics and design.