COVID-19 prophylaxis with hydroxychloroquine in Front-line Health and Allied-Health Care Workers: The COVID-SHIELD Trial

Abstract

As the world continues to fight the global pandemic of COVID-19, health resources in many Australian hospitals are expected to reach capacity and become overwhelmed. COVID-19 which is caused by the newly identified virus SARS-CoV-2, can result in a severe respiratory illness requiring ventilator support and sometimes lead to death. Front-line health care workers are at an increased risk of becoming infected due to repeated exposure in their occupational role in caring for patients with COVID-19. There is an urgent need for better drug options for COVID-19 as currently there are no known effective therapies above delivering best supportive hospital intensive care. Hydroxychloroquine is a well-known well-tolerated immune-modulatory drug widely used in rheumatological conditions. It has anti-malarial properties but has also exhibited in vitro anti-viral activity against SARS-CoV-2. It is currently in clinical trials as both a treatment option and as prophylaxis (prevention) for COVID-19. This large Australian multi-centre randomised double-blind placebo-controlled study aims to evaluate the efficacy of hydroxychloroquine as prophylaxis against COVID-19 in high-risk health care workers. It will enroll 2250 participants who will be randomised in a 1:1 ratio to take hydroxychloroquine orally daily or placebo for 4 months. The primary endpoint will be incidence of COVID-19.