ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease

This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 96 hours of confirmation of a positive COVID-19 result, and within 12 days of symptom onset, reduces the occurrence of severe COVID-19 disease. Severe disease is defined as the composite of hospitalization, invasive mechanical ventilation and 30-day mortality. This trial will enrol consenting adults who are not hospitalized, are age 18 or over, have a risk factor for severe disease, have no contraindication to treatment with hydroxychloroquine, can swallow pills, and who do not have a severe underlying comorbidity where treatment is not likely to be beneficial to the patient. Secondary outcomes will be the proportion of participants requiring hospitalization, invasive mechanical ventilation, 30-day mortality, and disposition at 30 days, defined as recovered, ongoing symptoms but not hospitalized, hospitalized, or deceased. Randomization will be stratified by age, risk of severe disease, and Alberta Health zone of primary residence. A pre-specified risk classification that includes immunosuppressed status will define those at high risk of severe disease. Health care delivery across Alberta Health zones will likely differ, in part due to the remote location of most patients in some zones. Alberta has a single publicly funded health care system with processes and administrative data that will allow complete capture of health system encounters and resource utilization. The population is ethnically diverse. In 2016, 23.5% of Albertans belonged to a visible minority group compared with 22.3% for Canada overall (1). Also, in 2018, 94.1% of Albertans age 15 and older used the internet for personal use compared with 91.3% for Canada overall; this excluded full-time residents of institutions (2). This will support a high degree of electronic recruitment and data capture. The current COVID-19 epidemic has also paused most ongoing research, thus providing access to many experienced researchers and highly trained research staff. Lack of any proven treatments for this severe condition makes it imperative that we use the resources we have to try to improve the lives of Albertans and determine if there is evidence for the use of hydroxychloroquine for confirmed COVID-19 disease, overall, and in high risk participants.