COVID-19 Clinical Trial
Official title:
ChemoPROphyLaxIs For covId-19 Infectious Disease (the PROLIFIC Trial)
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire National Health Service (NHS) to cope with the increased demand. The availability of personal protective equipment is limited and reports of high risk procedures such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source of great concern for infection transmission. Frontline NHS staff with direct patient contact have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease. Efforts to protect these workers from development of COVID-19, using drugs to prevent the disease, require urgent evaluation.
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2
coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability
of the entire National Health Service (NHS) to cope with the increased demand. The
availability of personal protective equipment is limited and reports of high risk procedures
such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source
of great concern for infection transmission. Frontline NHS staff with direct patient contact
have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease.
Efforts to protect these workers from development of COVID-19, using drugs to prevent the
disease, require urgent evaluation.
This trial will be a double-blind, randomized, placebo-controlled trial in a cohort of
frontline healthcare workers, who will potentially be exposed to SARS-CoV-2. Eligible
participants will be frontline NHS workers aged 18 to 70 years who work in a healthcare
setting with direct patient care. Participants will be randomised to one of 3 arms and
receive either: (1) Hydroxychloroquine Daily (loading phase: 800mg for first 2 days;
maintenance phase: 1 x 200mg tablet every day) + weekly placebo; (2) Hydroxychloroquine
weekly (loading phase: 800mg for first 2 days; maintenance phase: 2 x 200mg tablets every 7th
day/weekly) + daily placebo, or (3) placebo (daily and weekly).
Participants will be reviewed at an interim visit 6 weeks after baseline and again and the
end of the study treatment in 90 days (approximately 3 months) after randomization.
Participants will also complete brief questions about their health weekly while on treatment
(remotely, via app/web/phone-based interface).
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