Dataset Information

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

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.

SUBMITTER: Eikelboom J

PROVIDER: S-EPMC8887957 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Eikelboom John J Rangarajan Sumathy S Jolly Sanjit S SS Belley-Cote Emilie P EP Whitlock Richard R Beresh Heather H Lewis Gayle G Xu Lizhen L Chan Noel N Bangdiwala Shrikant S Diaz Rafael R Orlandini Andres A Hassany Mohamed M Tarhuni Wadea M WM Yusufali A M AM Sharma Sanjib Kumar SK Kontsevaya Anna A Lopez-Jaramillo Patricio P Avezum Alvaro A Dans Antonio L AL Wasserman Sean S Felix Camilo C Kazmi Khawar K Pais Prem P Xavier Denis D Lopes Renato D RD Berwanger Otavio O Nkeshimana Menelas M Harper William W Loeb Mark M Choudhri Shurjeel S Farkouh Michael E ME Bosch Jackie J Anand Sonia S SS Yusuf Salim S

CJC open 20220301 6

<h4>Background</h4>Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging.<h4>Methods</h4>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 de ...[more]

PMID: 35252829

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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