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Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial.
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; Lansky, Alexandra.
  • Shah T; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • McCarthy M; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Nasir I; Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
  • Archer H; Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
  • Ragheb E; Yale University School of Medicine, New Haven, CT, United States of America.
  • Kluger J; Yale University School of Medicine, New Haven, CT, United States of America.
  • Kashyap N; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Paredes C; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Patel P; Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
  • Lu J; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Kandel P; Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
  • Song C; Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
  • Khan M; Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
  • Ul Haq F; Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.
  • Ahmad R; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Howes C; Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
  • Cambi B; Yale New Haven Health System, CT, United States of America; Lawrence & Memorial Hospital, New London, CT, United States of America.
  • Lancaster G; Yale New Haven Health System, CT, United States of America; Bridgeport Hospital, Bridgeport, CT, United States of America.
  • Cleman M; Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
  • Dela Cruz CS; Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
  • Parise H; Yale University School of Medicine, New Haven, CT, United States of America.
  • Lansky A; 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.
Contemp Clin Trials ; 110: 106547, 2021 11.
Article in English | MEDLINE | ID: covidwho-1372905
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 11 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).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hydroxymethylglutaryl-CoA Reductase Inhibitors / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: J.cct.2021.106547

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hydroxymethylglutaryl-CoA Reductase Inhibitors / COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: J.cct.2021.106547