COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000501943.aspx

Prof Marc Pellegrini

pellegrini@wehi.edu.au

2020-04-22

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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

2

Walter and Eliza Hall Institute of Medical Research

18

70

Australia

Health workers

N/A

650

Incidence of COVID-19 using standard PCR analysis for COVID-19 [Daily during 4 months of intervention period]

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]