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ACT COVID-19

Official Title

Anti-Coronavirus Therapies to Prevent Progression of COVID-19 Trial

Status

Ongoing

Overview

ACT-COVID-19 is a randomized clinical trial to assess therapies to reduce the clinical progression of Coronavirus disease 2019 (COVID-19).

The ACT-COVID-19 program consists of two parallel trials evaluating azithromycin and chloroquine therapy versus usual care in outpatients and inpatients who have tested positive for severe acute respiratory syndrome coronavirus 2 (COVID-19). The trial is an open-label, parallel group, randomized controlled trial with an adaptive design. Adaptive design features 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: Mortality; invasive mechanical ventilation; admission to intensive care unit; renal replacement therapy; extracorporeal support.

Inpatient trial

Primary outcome: Composite of invasive mechanical ventilation or mortality (and its components).

Secondary outcomes: Admission to intensive care unit; renal replacement therapy; extracorporeal support.

Number of Patients

1530

Number of Sites

3

Number of Countries

1

Study Period

2020

Principal Investigator

Richard Whitlock, Emilie Belley-Cote, Salim Yusuf, Mark Loeb, Dominik Mertz, Sonia Anand, John Eikelboom, Jackie Bosch, Darryl Leong, Hertzel Gerstein

Program Manager

Brandi Meeks

Research Coordinator

Tara Robertson

Collaborators

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

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