Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial
Authors
Tayyab Shah, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Marianne McCarthy, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Irem Nasir, Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Herb Archer, Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Elio Ragheb, Yale University School of Medicine, New Haven, CT, United States of America.
Jonathan Kluger, Yale University School of Medicine, New Haven, CT, United States of America.
Nitu Kashyap, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Carlos Paredes, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Prashant Patel, Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
Jing Lu, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Prakash Kandel, Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
Christopher Song, Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
Mustafa Khan, Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Faheem Ul Haq, Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.
Rami Ahmad, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Christopher Howes, Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Brian Cambi, Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
Gilead Lancaster, Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.
Michael Cleman, Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Charles S. Dela Cruz, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Helen Parise, Yale University School of Medicine, New Haven, CT, United States of America.
Alexandra Lansky, Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America. Electronic address: alexandra.lansky@yale.edu.
Publication Title
Contemporary clinical trials
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).
DOI
10.1016/j.cct.2021.106547
Publication Date
11-1-2021
Recommended Citation
Shah, Tayyab; McCarthy, Marianne; Nasir, Irem; Archer, Herb; Ragheb, Elio; Kluger, Jonathan; Kashyap, Nitu; Paredes, Carlos; Patel, Prashant; Lu, Jing; Kandel, Prakash; Song, Christopher; Khan, Mustafa; Ul Haq, Faheem; Ahmad, Rami; Howes, Christopher; Cambi, Brian; Lancaster, Gilead; Cleman, Michael; Dela Cruz, Charles S.; Parise, Helen; and Lansky, Alexandra, "Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial" (2021). Randomized Controlled Trial. 45.
https://scholar.bridgeporthospital.org/randomized_trial/45
Identifier
34461322 (pubmed); PMC8397504 (pmc); 10.1016/j.cct.2021.106547 (doi); S1551-7144(21)00283-4 (pii)
