Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) announced Thursday it had formed two committees for its Phase II/III trial examining the efficacy of CardiolRx in high-risk coronavirus (COVID-19) patients.
The Oakville, Ontario-based company said that the Data Safety Monitoring Committee (DSMC) and the Clinical Endpoint Committee (CEC) will be involved in the ongoing trial, which looks at 422 patients hospitalized with COVID-19 at clinics throughout the US.
CardiolRx is a pharmaceutically produced oral cannabidiol formulation that could be a cardioprotective therapy to reduce mortality and major cardiovascular events in COVID-19 patients either diagnosed or at risk of cardiovascular disease, and to investigate the influence CardiolRx has on key markers of inflammatory heart disease.
READ: Cardiol Therapeutics completes Phase I trial of lead drug CardiolRx
The first committee, the Data Safety Monitoring Committee (DSMC), is made up of independent experts who will assess patient safety data and critical efficacy endpoints of the trial if needed. According to Cardiol, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial. After each data review, the DSMC will advise the study’s steering committee on recommendations for protocol modifications, if concerns over safety have developed, or that the study should continue according to the protocol if no concerns are identified.
The group will also perform an interim analysis after 200 patients have completed the study to determine if the study is likely to enroll enough patients to achieve statistical significance or if additional patients should be recruited, Cardiol told shareholders.
The second committee, the Clinical Endpoint Committee (CEC), comprises three clinical experts in cardiology and intensive care. The CEC will ensure accurate and consistent assessment of the trial endpoints and/or serious adverse effects. Its members will be blind to treatment assignment to ensure an unbiased endpoint assessment.
Cardiol is a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease.
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