LA UDES PUBLICA
Fecha de publicación:
2022-06-01
Tipo:
Article
Identificación:
SCOPUS_ID:85130490201
eID:
2-s2.0-85130490201
Nombre de la revista:
CJC Open
Título del artículo:

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

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.

Autor(es) UDES:
Lopez-Jaramillo P.
Otros Autores:
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., 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.
Autor Principal:
Eikelboom J.
Áreas del conocimiento:
Cardiology and Cardiovascular Medicine
Acerca de la revista donde se publicó este artículo:

CJC Open

Cuartil Q2
Ranking
7927
Tipo
Journal
eISSN
2589790X
Región
Northern America
País
United States
Volumen
4
Rango de páginas
568-576
Cobertura
2019-2022
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