COVID-19: Improving the Evidence to Treat an Emerging Infection Through Observational Studies and a Randomized Trial

The clinical management of COVID-19 remains unclear. First, we do not know what the disease is yet; we are still learning a great deal about what it causes in humans. We do not know what treatments to give, what risk factors are present for severe disease, and how long people are sick. We are proposing a national observational study of hospitalized patients with confirmed COVID-19, with an embedded randomized clinical trial of an antiviral agent. The observational study will build on work that we have been doing for the past four years, with pre-established protocols and data collection infrastructure just for this purpose. The randomized clinical trial will be with global collaborators to make sure that Canadian patients inform the world, and vice versa, about how to best treat this new disease. Alongside this, we will conduct surveys of clinicians, researchers, and the public about how they understand this new outbreak, how they feel about participating in research during a major outbreak, and what should be done differently; all of which will inform our clinical studies. Finally, we have been asked by the WHO to conduct a formal guideline for the management of COVID-19, which we will perform as data begins to emerge from the clinical trials that are ongoing. All of these proposals, put together, create a suite of approaches to better understanding and managing a new infection. Our team is large and diverse, and has been prepared for this outbreak for a number of years, and are ready to help Canadians respond in an evidence-informed way