PROLIFIC ChemoprophylaxisTrial (COVID-19)
ChemoPROphyLaxIs For covId-19 Infectious Disease (the PROLIFIC Trial)
1 other identifier
interventional
1,000
1 country
1
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedStudy Start
First participant enrolled
May 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMay 13, 2020
May 1, 2020
6 months
April 7, 2020
May 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to positive COVID-19 disease
Time taken for incidence of COVID-19 disease between Hydroxychloroquine and placebo arms
Assessed up to 90 days
Secondary Outcomes (4)
Number of COVID-19 test positive cases
Assessed up to 90 days
Number of COVID-19 serological test positive cases
Assessed up to 90 days
Severity of COVID-19 disease between each arm
Assessed up to 90 days
Number of common COVID-19 complications between each arm
Assessed up to 90 days
Study Arms (3)
Hydroxychloroquine - Daily dosing
ACTIVE COMPARATORHydroxychloroquine Daily (loading phase: 800mg for first 2 days; maintenance phase: 1 x 200mg tablet every day) + weekly placebo, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet
Hydroxychloroquine - Weekly dosing
ACTIVE COMPARATORHydroxychloroquine weekly (loading phase: 800mg for first 2 days; maintenance phase: 2 x 200mg tablets every 7th day/weekly) + daily placebo, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet
Placebo
PLACEBO COMPARATORPlacebo arm - 2 tablets twice daily for first 2 days (loading phase), followed by 1 tablet every day for 90 days plus 2 tablets every 7th day, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet
Interventions
Active HCQ: Days 1-2: Loading phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg capsule) taken ONCE A DAY, every day for 90 days (\~3 months), Matched Placebo HCQ: Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (\~3 months)
Active HCQ: Days 1-2: Loading Phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg capsules) taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (\~3 months) Matched Placebo HCQ: Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (\~3 months)
Matched placebo HCQ - daily dosing: Days 1-2: Loading Phase - 2 capsules taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (\~3 months) Matched placebo HCQ - weekly dosing Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (\~3 months)
Eligibility Criteria
You may qualify if:
- To be included in the trial the participant MUST:
- Have given written informed consent to participate
- Be aged 18 years to 70 years
- Not previously have been diagnosed with COVID-19
- Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care
You may not qualify if:
- Known COVID-19 positive test at baseline (if available)
- Symptomatic for possible COVID-19 at baseline
- Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines
- Known retinal disease
- Known porphyria
- Known chronic kidney disease (CKD; eGFR\<30ml/min)
- Known epilepsy
- Known heart failure or conduction problems
- Known significant liver disease (Gilbert's syndrome is permitted)
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Currently taking any of the following contraindicated medications:
- Digoxin
- Chloroquine
- Halofantrine
- Amiodarone
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Cheriyan, MBCHB, FRCP
Cambridge University Hospitals NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 20, 2020
Study Start
May 11, 2020
Primary Completion
October 31, 2020
Study Completion
April 1, 2021
Last Updated
May 13, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share