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The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges.
John Eikelboom1,2, Sumathy Rangarajan1, Sanjit S Jolly1,2
1Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.
CJC Open
|March 7, 2022
Summary
The Anti-Coronavirus Therapy (ACT) trials investigated colchicine and aspirin for COVID-19 treatment. These international trials faced challenges but will inform future research on anti-inflammatory and antithrombotic therapies.
Area of Science:
- Infectious Diseases
- Clinical Trials
- Pharmacology
Background:
- Effective COVID-19 treatments are crucial.
- Conducting randomized trials during the pandemic presented significant challenges.
Purpose of the Study:
- To evaluate the efficacy of colchicine as an anti-inflammatory therapy for COVID-19.
- To assess the efficacy of aspirin, alone or with rivaroxaban, as an antithrombotic therapy for COVID-19.
Main Methods:
- The Anti-Coronavirus Therapy (ACT) trials were parallel, factorial international trials.
- Outpatient arm: colchicine vs. usual care, aspirin vs. usual care.
- Inpatient arm: colchicine vs. usual care, rivaroxaban/aspirin vs. usual care.
Main Results:
- The outpatient trial enrolled 3917 patients; the inpatient trial enrolled 2611 patients.
- Challenges included limited preliminary data, event rate uncertainties, and regulatory delays.
- Enrollment concluded on February 10, 2022.
Conclusions:
- The ACT trials will determine the efficacy of colchicine and aspirin-based therapies across COVID-19 severity spectrums.
- Lessons learned will guide future clinical trial design and pandemic response strategies.
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