completed

ACT was a study to assess therapies to reduce the clinical progression of Coronavirus disease 2019 (COVID-19), evaluating combination of drugs to treat COVID-19 versus usual care in symptomatic outpatients and inpatients who have tested positive for COVID-19, across the spectrum of severity of the condition.

Two open-label, parallel group, randomized controlled trials – inpatient and outpatient – included adaptive intervention arms and adaptive sample size based on new and emerging data.

Outpatient Trial

Primary outcome: Hospital admission or death.

Secondary outcomes:

  • Composite of major adverse cardiovascular events: myocardial infarction (MI); stroke; acute limb ischemia (ALI); VTE, death.
  • Disease progression by 2 points on a 7-point scale.

Inpatient Trial

Primary outcome: Composite of invasive mechanical ventilation or mortality.

Secondary outcomes:

  • Composite of major adverse cardiovascular events: myocardial infarction (MI); stroke; acute limb ischemia (ALI); VTE, death.
  • Disease progression by 2 points on a 7-point scale.
ACT statistical analysis plan (download PDF) ACT protocol (download PDF) ACT outpatient trial: ESC 2022 (download PDF)
Study Type

Interventional - Drug

Study Design

Open-label parallel group RCT

NO. of Countries

15

NO. of Sites

136

NO. of Participants

6671

Study Period

2020 - 2022

Sponsor

PHRI

Canadian Institutes for Health Research (CIHR)

Bayer Canada

McMaster COVID-19 Research Fund

Thistledown Foundation Fast Grants

PHRI internal grant

Sanjit Jolly and C. Michael Gibson ESC 2022 on ACT trial

VIDEO: Sanjit Jolly talks to C. Michael Gibson about the ACT COVID inpatient and outpatient trials at ESC Congress 2022

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