Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The study is a double-blind, randomised, placebo-controlled trial that will be conducted
primarily in healthcare settings and other facilities directly involved in COVID-19 case
management. We will recruit healthcare workers and other persons at risk of contracting
COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000
participants and we predict an average of 400-800 participants per site in 50-100 sites.
The participant will be randomised to receive either chloroquine or placebo (1:1
randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of
10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg
chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.
If the participant is diagnosed with COVID-19, they will take continue to take the study
medication until:
- 90 days after enrolment (i.e., completion of kit)
- hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case
they will stop, or
- advised to stop by their healthcare professional for other reasons
Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical
outcomes will be recorded in the Case Record Form during the follow-up period.