The Anti-Coronavirus Therapies (ACT) Trials: design, baseline characteristics, and challenges. Eikelboom, J., Rangarajan, S., Jolly, S. S, Belley-Cote, E. P, Whitlock, R., Beresh, H., Lewis, G., Xu, L., Chan, N., Bangdiwala, S., Diaz, R., Orlandini, A., Hassany, M., Tarhuni, W. M, Yusufali, A M, Sharma, S. K., Kontsevaya, A., Lopez-Jaramillo, P., Avezum, A., Dans, A. L, Wasserman, S., Felix, C., Kazmi, K., Pais, P., Xavier, D., Lopes, R. D, Berwanger, O., Nkeshimana, M., Harper, W., Loeb, M., Choudhri, S., Farkouh, M. E, Bosch, J., Anand, S. S, & Yusuf, S. CJC Open, Elsevier BV, mar, 2022.
The Anti-Coronavirus Therapies (ACT) Trials: design, baseline characteristics, and challenges [link]Paper  doi  abstract   bibtex   
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 3,500 outpatients and 2,500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine versus usual care, and aspirin versus usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine versus usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily versus usual care. The primary outcome for the colchicine randomization is need for high flow oxygen, mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization is major thrombotic events, need for high flow oxygen, mechanical ventilation, or death. Results At the completion of enrolment on February 10, 2022, the outpatient trial had enrolled 3,917 patients and the inpatient trial 2,754 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.
@article{Eikelboom2022,
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 3,500 outpatients and 2,500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine versus usual care, and aspirin versus usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine versus usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily versus usual care. The primary outcome for the colchicine randomization is need for high flow oxygen, mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization is major thrombotic events, need for high flow oxygen, mechanical ventilation, or death. Results At the completion of enrolment on February 10, 2022, the outpatient trial had enrolled 3,917 patients and the inpatient trial 2,754 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.},
author = {Eikelboom, John and Rangarajan, Sumathy and Jolly, Sanjit S and Belley-Cote, Emilie P and Whitlock, Richard and Beresh, Heather and Lewis, Gayle and Xu, Lizhen and Chan, Noel and Bangdiwala, Shrikant and Diaz, Rafael and Orlandini, Andres and Hassany, Mohamed and Tarhuni, Wadea M and Yusufali, A M and Sharma, Sanjib Kumar and Kontsevaya, Anna and Lopez-Jaramillo, Patricio and Avezum, Alvaro and Dans, Antonio L and Wasserman, Sean and Felix, Camilo and Kazmi, Khawar and Pais, Prem and Xavier, Denis and Lopes, Renato D and Berwanger, Otavio and Nkeshimana, Menelas and Harper, William and Loeb, Mark and Choudhri, Shurjeel and Farkouh, Michael E and Bosch, Jackie and Anand, Sonia S and Yusuf, Salim},
doi = {10.1016/j.cjco.2022.02.010},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Eikelboom et al. - 2022 - The Anti-Coronavirus Therapies (ACT) Trials design, baseline characteristics, and challenges.pdf:pdf},
issn = {2589790X},
journal = {CJC Open},
keywords = {OA,fund{\_}not{\_}ack,protocol},
mendeley-tags = {OA,fund{\_}not{\_}ack,protocol},
month = {mar},
pages = {10.1016/j.cjco.2022.02.010},
pmid = {35252829},
publisher = {Elsevier BV},
title = {{The Anti-Coronavirus Therapies (ACT) Trials: design, baseline characteristics, and challenges}},
url = {http://www.cjcopen.ca/article/S2589790X22000488/fulltext http://www.cjcopen.ca/article/S2589790X22000488/abstract https://www.cjcopen.ca/article/S2589-790X(22)00048-8/abstract https://linkinghub.elsevier.com/retrieve/pii/S2589790X22000488},
year = {2022}
}
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