None listed
Conditions
Brief summary
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.
Interventions
a) Hydroxychloroquine or placebo to match will be administered orally once daily; 400mg (>=65kg body weight) or 200mg (<65kg body weight);
b) the duration of administration will be for 4 months total;
c) the mode of administration oral capsule;
d) adherence to medication administration will be done via a daily reminder text message. At the completion of the study, study drug accountability will be performed and blood analysis for Hydroxychloroquine at baseline and completion.
Sponsors
Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Study participant is willing to provide informed consent 2. Be aged 18-70 years at the time of consent and in good overall health 3. Health care worker at high risk of COVID-19 exposure including doctors, nurses and other allied health care workers (such as physiotherapist, radiographer, speech/occupational therapists, personal services assistants, dentist/dental nurse/dental hygienists, aged care workers, optometrist, in general practice or other health care services or paramedic (ambulance) in the following settings: • Emergency department • COVID-19 management teams: Outpatient Clinic • Inpatient Ward • Intensive care unit/ High Dependency Unit (HDU) /Operating Theatre/ Recovery • Groups exposed to aerosol generating procedures: eg. anaesthetics/intubation teams • Dental Services • Aged Care Homes • Optometry Services • Otolaryngology Services (ENT) • Occupational & Speech Therapy • Physiotherapy • Paramedicine/Ambulatory • Radiology • General Practice • Other Health Care Services Worker 4. Anticipated to be performing clinical duties as a front-line health care worker during the trial period 5. Willing to adhere to study procedures including daily use of mobile electronic portal to report outcomes and adverse events 6. Willing to take drug/placebo as directed and to not take additional hydroxychloroquine or chloroquine during the trial period 7. Willing to provide COVID-19 test results and permission to use the COVID-19 registry at the end of the study to confirm COVID-19 status 8. Willing to report hospitalisations to the study nurse and to have review of medical records and receive follow-up phone calls to determine outcomes of hospitalisations
Exclusion criteria
1. Prior COVID-19 2. Presence of any respiratory illness inclusive of fever, cough, dyspnoea, sore throat, rhinorrhoea, nasal stuffiness, headache, myalgia and fatigue 3. Any cardiac arrhythmias, retinal eye disease, liver or kidney disease 4. Any contra-indication to hydroxychloroquine or chloroquine including allergy or hypersensitivity 5. Any concurrent medication which can prolong QT interval 6. Currently taking or planning to self-treat with hydroxychloroquine or chloroquine 7. Immunosuppressive conditions or medications 8. Pregnancy or breast feeding 9. Concurrent participation in other COVID-19 clinical trials 10. Inability to follow study procedures during the trial period 11. Inability to provide informed consent 12. Lack of fluency in the English language as this will impede the ability of the participant to interact with the web-based data collection platform
Outcome results
None listed