Anti-Coronavirus Therapies–Outpatient - ACT–Outpatient
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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