The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges

John Eikelboom, Sumathy Rangarajan, Sanjit S. Jolly, Emilie P. Belley-Cote, Richard Whitlock, Heather Beresh, Gayle Lewis, Lizhen Xu, Noel Chan, Shrikant Bangdiwala, Rafael Diaz, Andres Orlandini, Mohamed Hassany, Wadea M. Tarhuni, A. M. Yusufali, Sanjib Kumar Sharma, Anna Kontsevaya, Patricio Lopez-Jaramillo, Alvaro Avezum, Antonio L. DansSean Wasserman, Camilo Felix, Khawar Kazmi, Prem Pais, Denis Xavier, Renato D. Lopes, Otavio Berwanger, Menelas Nkeshimana, William Harper, Mark Loeb, Shurjeel Choudhri, Michael E. Farkouh, Jackie Bosch, Sonia S. Anand, Salim Yusuf

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Background: Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging. Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3500 outpatients and 2500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine vs usual care, and aspirin vs usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization, it is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine vs usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily vs usual care. The primary outcome for the colchicine randomization is need for high-flow oxygen, need for mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization, it is major thrombotic events, need for high-flow oxygen, need for mechanical ventilation, or death. Results: At the completion of enrollment on February 10, 2022, the outpatient trial had enrolled 3917 patients, and the inpatient trial had enrolled 2611 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals, and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic. Conclusions: The ACT trials will determine the efficacy of anti-inflammatory therapy with colchicine, and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban, across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.

Original languageEnglish
Pages (from-to)568-576
Number of pages9
JournalCJC Open
Volume4
Issue number6
DOIs
Publication statusPublished - Jun 2022
Externally publishedYes

Fingerprint

Dive into the research topics of 'The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges'. Together they form a unique fingerprint.

Cite this