Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial

Summary

This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized patients with SARS-CoV-2

Timeline

Start

2020-10-30

Primary completion

2022-03-30

Completion

2022-03-30

Outcome

Missed primary endpoint

paper There was no significant difference in the primary endpoint at 30 days between the active arm and standard of care arm (15.2% vs 8.8%, respectively, p=0.17). PMID 36828654 ↗

paper the combination of colchicine and rosuvastatin in addition to standard of care did not appear to reduce the risk of progression of COVID-19 disease or thromboembolic events PMID 36828654 ↗

Publications

• Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Huang H, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open. 2023 Feb 24;13(2):e067910. doi: 10.1136/bmjopen-2022-067910.
• Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz CS, Parise H, Lansky A. Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial. Contemp Clin Trials. 2021 Nov;110:106547. doi: 10.1016/j.cct.2021.106547. Epub 2021 Aug 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colchicine	Small molecule	0.6 mg	Oral
Subject	Rosuvastatin	Small molecule	40 mg	—

Indications