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PROLIFIC ChemoprophylaxisTrial (COVID-19)

NCT04352933 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2020-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Hydroxychloroquine - Daily dosing

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)

DRUG

Hydroxychloroquine - Weekly Dosing

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)

OTHER

Matched Placebo Hydroxychloroquine

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)

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Joseph Cheriyan, MBCHB, FRCP · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2020-10-31
Completion
2021-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352933 on ClinicalTrials.gov