Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial

Summary

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

Timeline

Start

2020-04-21

Primary completion

2022-12-30

Completion

2022-12-30

Outcome

Missed primary endpoint

paper had a primary outcome (hazard ratio [HR] 1·04, 95% CI 0·90-1·21, p=0·58); PMID 36228641 ↗

paper experienced major thrombosis, hospitalisation, or death (HR 0·80, 95% CI 0·57-1·13, p=0·21). PMID 36228639 ↗

paper neither colchicine nor the combination of rivaroxaban and aspirin prevent disease progression or death. PMID 36228641 ↗

Publications

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
• Eikelboom JW, Jolly SS, Belley-Cote EP, Whitlock RP, Rangarajan S, Xu L, Heenan L, Bangdiwala SI, Luz Diaz M, Diaz R, Yusufali A, Kumar Sharma S, Tarhuni WM, Hassany M, Avezum A, Harper W, Wasserman S, Almas A, Drapkina O, Felix C, Lopes RD, Berwanger O, Lopez-Jaramillo P, Anand SS, Bosch J, Choudhri S, Farkouh ME, Loeb M, Yusuf S. Colchicine and the combination of rivaroxaban and aspirin in patients hospitalised with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial. Lancet Respir Med. 2022 Dec;10(12):1169-1177. doi: 10.1016/S2213-2600(22)00298-3. Epub 2022 Oct 10.
• Eikelboom JW, Jolly SS, Belley-Cote EP, Whitlock RP, Rangarajan S, Xu L, Heenan L, Bangdiwala SI, Tarhuni WM, Hassany M, Kontsevaya A, Harper W, Sharma SK, Lopez-Jaramillo P, Dans AL, Palileo-Villanueva LM, Avezum A, Pais P, Xavier D, Felix C, Yusufali A, Lopes RD, Berwanger O, Ali Z, Wasserman S, Anand SS, Bosch J, Choudhri S, Farkouh ME, Loeb M, Yusuf S. Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial. Lancet Respir Med. 2022 Dec;10(12):1160-1168. doi: 10.1016/S2213-2600(22)00299-5. Epub 2022 Oct 10.
• Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	75 mg	Oral
Subject	Aspirin	Small molecule	100 mg	Oral
Subject	Colchicine	Small molecule	0.5 mg	Oral
Subject	Colchicine	Small molecule	0.6 mg	Oral
Subject	Interferon-beta	Protein / enzyme biologic	0.25 mg	Subcutaneous
Subject	Rivaroxaban	Other / unclassified	2.5 mg	Oral

Indications