Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352933
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2020-04-07
Brief Title:
PROLIFIC ChemoprophylaxisTrial COVID-19
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
ChemoPROphyLaxIs For covId-19 Infectious Disease the PROLIFIC Trial
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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
Detailed Description:
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 eg 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 dayweekly 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 appwebphone-based interface
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 dayweekly 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 appwebphone-based interface
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None