Abstract
Background: Despite improvement in the standard of care (SOC) for hospitalized COVID-19 patients, rates of morbidity and mortality remain high. There continues to be a need for easily available and cost-effective treatments. Colchicine and rosuvastatin are both safe and well-studied medications with anti-inflammatory and other pleiotropic effects that may provide additional benefits to hospitalized COVID-19 patients.
Methods and results: The Colchicine/Statin for the Prevention of COVID-19 Complications (COLSTAT) trial is a pragmatic, open-label, multicenter, randomized trial comparing the combination of colchicine and rosuvastatin in addition to SOC to SOC alone in hospitalized COVID-19 patients. Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization. The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up. The primary endpoint is the 30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events. The secondary powered endpoint is the 30-day composite of death, respiratory failure requiring intubation, and myocardial injury.
Conclusions: The COLSTAT trial will provide evidence on the efficacy of repurposing colchicine and rosuvastatin for the treatment of hospitalized COVID-19 patients. Moreover, it is designed to be a pragmatic trial that will demonstrate the power of using electronic health records to improve efficiency and enrollment in clinical trials in an adapting landscape.
Clinical trial registration: NCT04472611 (https://clinicaltrials.gov/ct2/show/NCT04472611).
Keywords: COVID-19; Clinical trial; Colchicine; Electronic health record; Statin.
【저자키워드】 COVID-19, clinical trial, Electronic health record, statin, Colchicine, 【초록키워드】 Treatment, Efficacy, Respiratory failure, Trial, Open-label, randomization, Anti-inflammatory, randomized trial, intubation, Intervention, prevention, progression, myocardial injury, Health, clinical, Patient, death, Complication, Clinical improvement, morbidity and mortality, Follow-up, multicenter, USA, medication, severe COVID-19 disease, Evidence, Combination, primary endpoint, Pragmatic, Efficiency, Safe, World Health Organization, Standard of care, Enrollment, Endpoint, hospitalized COVID-19 patients, Stage, Verona, benefit, IMPROVE, defined, addition, New, 1:1 randomization, arterial/venous thromboembolic events, pleiotropic effect, 【제목키워드】 Trial, Complication, prevention of COVID-19,