Interventional - Drug
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.
Primary outcome: Hospital admission or death.
Primary outcome: Composite of invasive mechanical ventilation or mortality.
Additional Key Team Members
Co-Principal Investigators of the ACT study include:
Interventional - Drug
Open-label randomized controlled trial
2020 - 2021
Executive Director; Senior Scientist
Salim Yusuf is an internationally renowned cardiologist and epidemiologist, whose work over 40 years has substantially influenced prevention and treatment of cardiovascular disease. Born in India, medically qualified at St. John’s Medical College, Bangalore in 1976, he received a Rhodes Scholarship and obtained a DPhil from Oxford, during which he (along with Richard Peto, Rory Collins and Peter Sleight) initiated the concepts of large, simple trials, and meta-analysis. He proposed the concept of combination drug treatment for prevention of CVD to achieve large reductions in CVD with a single pill (now called the polypill concept), but more importantly has been evaluating the concept through large randomized trials.
He leads several global studies involving more than 60 countries in every inhabited continent of the world aimed at enhancing knowledge about the biological, behavioural and societal causes, consequences, and approaches to the control of heart diseases, and strokes through large multi-country programs such as INTERHEART, INTERSTROKE, and PURE.
He holds a Heart and Stroke Foundation of Ontario Research Chair and has received (among others) the Lifetime Research Achievement award of the Canadian Cardiovascular Society; the Paul Wood Silver Medal of the British Cardiac Society; the European Society of Cardiology gold medal, the clinical Research Prize of the American Heart Association and the International Award and the Braunwald Lecture of the American College of Cardiology. He has been inducted into the Royal Society of Canada and the Canadian Medical Hall of Fame; been appointed as an Officer of the Order of Canada, and received the Canada Gairdner Wightman Award in 2014. He has received four honorary doctorates, and is among the top 20 most cited health researchers in history.
Salim Yusuf has published more than 1,000 articles in refereed journals, rising to the second most cited researcher in the world for 2011. He has mentored more than 120 scientists, several of whom are in leadership positions across the globe. He has been President of the World Heart Federation (2015-2016), where he initiated several programs (the Emerging Leaders program, road maps for CVD control and a course for training primary care practitioners in CVD prevention) aimed at halving the CVD burden globally within a generation. The World Heart Federation has recognized his contributions by naming the program the Salim Yusuf Emerging Leaders Programme.
He is a Distinguished University Professor of Medicine, and Executive Director of the Population Health Research Institute, McMaster University and Chief Scientist, Hamilton Health Sciences.
John Eikelboom is Associate Professor in the Department of Medicine, McMaster University, and a haematologist in the Thrombosis Service, Hamilton General Hospital. He originally trained in Internal Medicine and Haematology in Perth, Australia and subsequently moved to Hamilton to take up a Tier II Canada Research Chair in Cardiovascular Medicine.
He has co-authored more than 350 articles in peer-reviewed journals. His current research, supported by the Canadian Institutes for Health Research, the Heart and Stroke Foundation and the National Health and Medical Research Council of Australia, focuses on the efficacy and safety of antithrombotic therapies, outcomes after blood transfusion and bleeding, and the mechanisms of variable response to antiplatelet drugs.
Richard Whitlock is Associate Professor, Department of Surgery, McMaster University, Scientist in the Perioperative and Surgery program at PHRI, and a cardiac surgeon and intensive care physician at Hamilton Health Sciences. His clinical focus is on aortic valve intervention and aortic surgery. He is a lead investigator for the CIHR funded studies SIRS, LAAOS III, and TRICS III, which have established a network of more than 120 centres to address important questions in his field.
He has published more than 90 articles in referred journals. Medically qualified at the University of Toronto, Richard received his specialist training in cardiac surgery and critical care medicine at McMaster University. In 2012, he received his PhD in clinical epidemiology.
Emilie Belley-Côté is an Assistant Professor in the Department of Medicine at McMaster University; she practices critical care cardiology in the cardiovascular intensive care unit and coronary care unit at the Hamilton General Hospital. Her research interests include perioperative cardiac surgery care, knowledge synthesis and guideline development. At this stage in her career, she has more than 120 publications, including articles in NEJM, Lancet, JAMA, as well as first-tier critical care journals.
She obtained her MD from Université de Sherbrooke in 2006. After internal medicine and cardiology training, as well as an MSc in Clinical Sciences, she completed a critical care fellowship at McMaster. In 2019, she completed a PhD in Health Research Methodology at McMaster University.
Sonia Anand is Professor, Medicine and Epidemiology, McMaster University, Director of the university’s Population Genomics Program, and Associate Chair, Diversity and Equity, Department of Medicine.
Her present research focuses upon the environmental and genetic determinants of vascular disease in populations of varying ancestral origin, women and cardiovascular disease. She has published more than 200 articles in peer review journals, has been inducted into the Canadian Academy of Health Sciences, and received the Queen Elizabeth II Diamond Jubilee Medal.
GMEL Director; CRLB Deputy Dir; Senior Scientist
Guillaume Paré is Director of the Genetic and Molecular Epidemiology Laboratory (GMEL) at PHRI, Deputy Director of the Clinical Research Laboratory and Biobank (CRLB), a Senior Scientist at PHRI, a Professor of Pathology and Molecular Medicine, a Professor, Health Research Methods, Evidence and Impact, and a University Scholar at McMaster University.
He holds the Cisco Professorship in Integrated Health Systems. His clinical interests are centered on lipoprotein disorders, obesity and cardiovascular disease prevention, with research interests in cardiovascular genetics, biomarker development and pharmacogenomics. Dr. Paré’s research combines high-throughput biomarker screens with genetics, bioinformatics and epidemiology to identify novel cardio-metabolic biomarkers. He has published more than 200 papers and has been cited over 27,000 times.
A medical biochemist with board certification from the Royal College of Physicians and Surgeons of Canada, Gui Paré completed a Master’s in Human Genetics at McGill University under the supervision of renowned geneticist Dr. Thomas Hudson. He further trained in genetic epidemiology with Dr. Paul Ridker at Harvard Medical School.
Deputy Director; Senior Scientist
Hertzel Gerstein is Deputy Director, PHRI, and our Senior Scientific Program Lead, Diabetes, as well as a Professor, Medicine, McMaster University. He is also Director of the Division of Endocrinology & Metabolism and Director of the Diabetes Care and Research Program. He has pioneered the application of large simple outcome trials to people with diabetes globally, and developed the concept of dysglycemia as an important risk factor for many of the serious health outcomes that afflict people with an elevated glucose level regardless of diabetes status. He currently leads clinical trials and epidemiological studies related to: a) the prevention and therapy of diabetes and its many consequences, and b) the role of dysglycemia and relative insulin insufficiency on the development of diabetes, cardiovascular disease, cognitive impairment and other chronic conditions. Key studies in which he has played or continues to play a major leadership role include HOPE, MICRO HOPE, ACCORD, DREAM, EpiDREAM, ORIGIN, TIDE, ACE, ELIXA and REWIND.
Hertzel Gerstein has published more than 300 papers, editorials and commentaries, mainly on diabetes-related issues and co-edited the textbook Evidence-Based Diabetes Care. He is an Associate Editor for ACP Journal Club, and is on the editorial board of the Journal of Diabetes and Lancet Diabetes and Endocrinology. He has received several honors including the Canadian Diabetes Association’s Young Scientist Award (1999), Frederick G. Banting award (1999), Charles H. Best award (2007) and Lifetime Achievement Award (2012).
Darryl Leong is a Scientist at PHRI, Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program, Associate Professor, Department of Medicine (Cardiology), McMaster University, and Staff Cardiologist at Hamilton Health Sciences. He has methodological expertise in clinical epidemiology and clinical trials, and content expertise in physical frailty, echocardiography, and cardio-oncology. His research is supported by the CIHR, and he has published more than 100 manuscripts including all the leading internal medical and cardiovascular journals.
He graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence, completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide in Australia, and completed a post-doctorate fellowship in cardiovascular imaging at the Leiden University Medical Centre in The Netherlands, before re-locating to Canada.
Sanjit Jolly is an interventional cardiologist at Hamilton Health Sciences and associate professor at McMaster University. He has formal training in clinical trials with a M.Sc. in Health Research Methodology from McMaster. He was the principal investigator of the RIVAL trial, a randomized trial of 7021 patients comparing radial and femoral access for coronary intervention. He is also the principal investigator trial of the ongoing TOTAL trial, an international randomized trial (N=10,700) of thrombectomy during primary PCI.
Noel Chan is an Assistant Professor in the Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, specializing in anticoagulant therapy and thrombosis medicine. His research seeks to improve our understanding of the triggers for thrombosis (including the role of inflammation) and the determinants of variable response to antithrombotic therapies to inform on novel strategies that have the potential to further reduce the burden of thrombosis.
Domenik Mertz is Associate Professor, Division of Infectious Diseases, Department of Medicine, McMaster University, and Medical Director Infection Control at Hamilton Health Sciences. His research interests include the epidemiology and risk factors for resistance and infections by resistant bacteria; prevention of C. difficile infection; infection control and of hospital epidemiology; and antimicrobial stewardship.
He has published more than 60 peer reviewed articles to date, is an associate editor for BMC Infectious Diseases, and serves as the first-named editor for the 3rd edition of the book ‘Evidence-based Infectious Diseases’.
Sumathy Rangarajan has been Program Director, Global Health, since 2016, preceded by many years’ service at PHRI in other roles. She oversees the PURE study team, as well as the INVICTUS rheumatic AF treatment trial, the CANPWR pediatric weight management registry, and others.
She holds both a Bachelor of Science Degree and a Master of Science degree from Pune University in India.
Associate Program Manager
Heather Beresh has worked at PHRI since May 2002, largely devoted to managing global, multi-centre clinical trials of antithrombotic therapies in patients with atrial fibrillation (AF). She started as research coordinator for the ACTIVE study evaluating dual antiplatelet therapy and angiotensin receptor blockers in patients with AF, then continued with oversight of the AVERROES open label extension trial evaluating a novel oral anticoagulant in the same population, and ARTESiA evaluating anticoagulant therapy in patients with subclinical AF.
In addition, she has coordinated trials of ablation procedures versus anti-arrhythmic medications and trials evaluating screening strategies for AF. Heather also manages network collaborations, including the Canadian Stroke Prevention Intervention Network (CSPIN). She has as a Master’s degree in Medical Sciences from McMaster University.
Associate Program Manager
Dipika Desai oversees many epidemiologic studies, including the South Asian birth cohort, START, the South Asian Heart Risk Assessment (SAHARA), and the Canadian Alliance for Healthy Hearts and Minds (CAHHM), as well as management assistance and oversight in the utilization of samples from a number of other studies.
She has a Bachelor’s degree in Food and Nutrition from the M S University in Baroda, India, and a Master’s degree in Human Nutrition from the University of British Columbia.
Associate Program Manager
Gayle Lewis joined PHRI’s Arrhythmia group in 2005 to work on the RELY trial; she started up the AVERROES trial in 2007, which she managed until its 2010 close. In 2012, Gayle moved to PHRI’s Global Health program, where she works on various epidemiological studies including PURE, as well as the rheumatic AF treatment study, INVICTUS.
Prior to joining McMaster University, she worked in Toronto at Digital Equipment of Canada for 5 years and was responsible for the development, testing, implementation and training of the Canadian Automatic Quoting system (AQS) for all Sales Representatives across Canada.
She has been an employee of McMaster University since 1989 when she joined the Clinical Epidemiology & Biostatistics Group, and remained on campus until 1992, at which time she relocated to the Clinical Trials Methodology Group.
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