CATCO Scale-Up COVID‑19 Supplement – Canadian Treatments for COVID-19: SOLIDARITY

Murthy, Srinivas | $3,500,000

British Columbia University of British Columbia 2021 CIHR Operating Grant

There is a great ongoing need for simple, large randomized clinical trials to answer clinically important questions during this pandemic. Patients, policymakers, and clinicians need answers as to whether therapies are effective from clinical trials that are definitive, valid, and generalizable. With over 20,000 new COVID19 cases per week in Canada and 3 million new cases per week globally, there is still both an urgent need and opportunity to answer these questions through clinical trials designed to investigate differences in mortality. Trials that are simple and scalable are the ones that are informing global clinical practice. Unfortunately, the start of this pandemic led to many small, uncoordinated clinical trials. Given the complexity of establishing or coordinating clinical trial networks, prioritizing interventions, and deciding upon trial design, thousands of small trials were initiated globally, most of which remain either unreported and not sufficiently sized or generalizable to convincingly inform clinical practice. The SOLIDARITY clinical trial was proposed at a World Health Organization (WHO) meeting in Geneva in February 2020, with a globally coordinated Master protocol. SOLIDARITY is a simple, large trial, with only the most necessary baseline and outcome data collected, incorporating adequately powered subgroups for relevant baseline characteristics, specifically region, sex, co-morbidities, and severity of disease. Naming a trial ‘SOLIDARITY’ is not for an acronym – it is a principle for researchers, funders, and clinicians in working globally to determine the most effective therapies and reduce lives lost. Canada has been instrumental in the design and oversight of the SOLIDARITY trial and have thus far recruited over 1300 patients to CATCO (Canadian Treatments for COVID19) since March 2020, an independently sponsored trial directly contributing data to SOLIDARITY. Its first publication was in the New England Journal of Medicine in late 2020, with a subsequent analysis to be released imminently. In this next phase of CATCO, we will continue to grow our clinical trial network across Canada and contribute to the global knowledge on effective treatments for COVID19. The next four agents in this adaptive trial are artesunate, infliximab, narsoplimab, and imatinib. Canada has emerged, through the work of its clinical experts, scientists, and funders, as a global leader in COVID19 clinical management. Through this proposal, we will continue this leadership, and produce the evidence to inform clinical and health system management. Trials such as CATCO/SOLIDARITY and the COVID Network of Clinical Trials Networks are establishing the foundations of an efficient and durable mechanism to respond to both COVID19 and subsequent unanticipated and anticipated threats to health in the years ahead.

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