Anti-Coronavirus Therapies–Outpatient - ACT–Outpatient

Aug 29, 2022
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Canadian Institutes for Health Research, Bayer AG, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation.
Date Presented:
08/29/2022
Date Published:
08/29/2022
Date Updated:
08/29/2022
Original Posted Date:
08/29/2022
References

Contribution To Literature:

Among outpatients with COVID-19 in the ACT–Outpatient trial, the addition of colchicine or aspirin had no benefit compared with control for mortality or need for hospitalization.

Description:

The goal of the trial was to assess the safety and efficacy of colchicine and aspirin among outpatients with coronavirus disease 2019 (COVID-19).

Study Design

Patients were randomized in a 2 x 2 factorial fashion to either colchicine (n = 1,956) vs. control (n = 1,961), or aspirin (n = 1,964) vs. control (n = 1,953).

  • Total number of patients: 3,917 in each group
  • Duration of follow-up: 45 days
  • Mean patient age: 45 years
  • Percentage female: 40%

Inclusion criteria:

  • Symptomatic and laboratory-confirmed diagnosis of COVID-19
  • Age ≥30 years
  • High risk (one or more of the following: age ≥70 years, male, body mass index ≥30 kg/m2, chronic disease, active cancer, diabetes)
  • Within 7 days of diagnosis or worsening clinically

Exclusion criteria:

  • Advanced kidney or liver disease
  • Pregnancy (known or potential) or lactation
  • Allergy or planned use of study interventions

Other salient features/characteristics:

  • Fully vaccinated: 21%

Principal Findings:

The primary outcome, hospitalization or death, for colchicine vs. control was: 3.4% vs. 3.3% (hazard ratio 1.02, 95% confidence interval [CI] 0.72-1.43, p = 0.93).

  • Death: 0.6% vs. 0.6% (p = 0.84)
  • Hospitalization: 3.2% vs. 3.1% (p = 0.92)

The primary outcome, major thrombosis, hospitalization, death, for aspirin vs. control was: 3.1% vs. 3.7% (HR 0.80, 95% CI 0.57-1.13, p = 0.21).

  • Death: 0.6% vs. 0.6% (p = 0.84)
  • Any thrombosis: 0.1% vs. 0.3% (p = 0.27)

Interpretation:

The results of this trial indicate that among outpatients with COVID-19, the addition of colchicine or aspirin had no benefit compared with control for mortality or need for hospitalization. One limitation is that no placebo was used in this trial.

References:

Presented by Dr. John William Eikelboom at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 29, 2022.

Clinical Topics: COVID-19 Hub, Prevention

Keywords: Aspirin, Body Mass Index, Chronic Disease, Colchicine, COVID-19, COVID-19 Vaccines, ESC22, ESC Congress, Neoplasms, Outpatients, Primary Prevention, Thrombosis


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