Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) has selected Worldwide Clinical Trials as its contract research organization for its Phase II/III trial studying the effectiveness of CardiolRx in COVID-19 patients.
Oakville, Ontario-based Cardiol’s Phase II/III study is a double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of CardiolRx, a pharmaceutically-produced extra strength cannabidiol formulation.
Worldwide supports drug development in over 60 countries and has offices in the Americas, Europe and Asia. It is one of the major CROs involved in international COVID-19 trials.
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The trial will include 422 hospitalized COVID-19 patients who either have a prior history or are at risk of developing cardiovascular disease.
"We are pleased to be collaborating with Worldwide Clinical Trials as we initiate our Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the US,” said David Elsley, CEO of Cardiol Therapeutics in a statement.
"While this potentially registrational trial is designed primarily to evaluate the impact of CardiolRx on reducing mortality and major cardiovascular outcomes in COVID-19 patients who have a prior history of, or risk factors for, cardiovascular disease, this important study will also investigate the therapy's influence on key markers of inflammatory heart disease.”
The findings are expected to provide “invaluable data” about the therapeutic potential of CardiolRx to help treat inflammatory heart disease and heart failure – a leading cause of death and disability in developed nations, Elsley added.
The study team is co-chaired by Dr Dennis McNamara, professor of medicine and director of the Center for Heart Failure Research at the University of Pittsburgh, and Dr Leslie Cooper, chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and chair of the Clinic’s Department of Cardiovascular Medicine.
Cardiol told investors that its rationale for using cannabidiol to treat patients with COVID-19 is based on its reported anti-inflammatory and cardioprotective effects, which could prevent COVID-19-related cardiovascular complications and reduce morbidity and mortality.
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