Canadian Treatments for COVID-19: SOLIDARITY

This proposal is for an adaptive, randomized, open-label, controlled clinical trial for the treatment of COVID19, in collaboration with countries around the world, working in solidarity with the World Health Organization. We are currently active in 22 centres across the country, have randomized 70 patients at time of writing across multiple provinces, and are funded for 440 participants through the first rapid response fund from CIHR for coronavirus. This proposal is to expand to 80 sites across the country and enrol thousands of patients, over the course of this and subsequent waves of the COVID19 pandemic over the next 1-2 years. Eligible and consenting hospitalized patients with COVID19 are being randomized to receive either standard-of-care or the study medication plus standard of care. Current approved study arms include: 1. Lopinavir/ritonavir 400mg/100mg PO BID for 14 day plus optimized supportive care, OR 2. Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care, OR 3. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR 4. Optimized support care. Inclusion criteria will be: Age = 18 years of age, has laboratory-confirmed SARS-CoV-2 infection, and is admitted to hospital at a participating centre. The primary outcome will be mortality at hospital discharge. CATCO is incorporated into the WHO Solidarity Global Trial, with interim results from many countries being reviewed by an independent Global Data Monitoring and Safety Committee. This Committee will decide how often to conduct interim analyses and when to declare effectiveness, futility, or harm. It is anticipated that many thousand patients will be recruited into this trial, with over 2000 globally at time of writing. The larger the numbers entered, the more accurate the results will be, both for all patients and for targeted subgroups; the numbers that can be entered will depend critically on how large the pandemic becomes. Inclusion criteria will be: Age = 18 years of age, has laboratory-confirmed SARS-CoV-2 infection, and is admitted to hospital at a participating centre. The primary outcome will be mortality at hospital discharge. CATCO is incorporated into the WHO Solidarity Global Trial, with interim results from many countries being reviewed by an independent Global Data Monitoring and Safety Committee. This Committee will decide how often to conduct interim analyses and when to declare effectiveness, futility, or harm. It is anticipated that many thousand patients will be recruited into this trial, with over 2000 globally at time of writing. The larger the numbers entered, the more accurate the results will be, both for all patients and for targeted subgroups; the numbers that can be entered will depend critically on how large the pandemic becomes.