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Research

Photo for ACT COVID-19

ACT COVID-19

Official Title

Anti-Coronavirus Therapies to Prevent Progression of COVID-19 (ACT) study

Status

Ongoing

Overview

ACT-COVID-19 is a study to assess therapies to reduce the clinical progression of Coronavirus disease 2019 (COVID-19). The study will consists of two parallel trials evaluating combination of drugs to treat COVID-19 versus usual care in symptomatic outpatients and inpatients who have tested positive for COVID-19. Two open-label, parallel group, randomized controlled trials are planned – inpatient and outpatient – with an adaptive design that include adaptive intervention arms and adaptive sample size based on new and emerging data.

Study Design

Open-label randomized controlled trial

Primary Endpoint

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), and 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), and disease progression by 2 points on a 7-point scale.

Number of Patients

4500

Number of Sites

130

Number of Countries

14

Study Period

2020-2021

Principal Investigator

Richard Whitlock, Emilie Belley-Cote, John Eikelboom, Salim Yusuf, Sonia Anand, Will Harper, Guillaume Pare, Noel Chan, Darryl Leong, Hertzel Gerstein, Mark Loeb, Dominik Mertz

Program Manager

Sumathy Rangarajan

Research Coordinator

Heather Beresh, Gayle Lewis, Dipika Desai

Collaborators

Mark Loeb, Department of Pathology and Molecular Medicine, McMaster University 

Dominik Mertz, Division of Infectious Diseases, Department of Medicine, McMaster University