The Chloroquine for Influenza Prevention Trial
CHIP
A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
1 other identifier
interventional
1,516
1 country
1
Brief Summary
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Shorter than P25 for phase_2
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
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 28, 2010
CompletedFirst Posted
Study publicly available on registry
March 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMarch 2, 2010
February 1, 2010
6 months
February 28, 2010
February 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laboratory-confirmed influenza-like illness
12 weeks
Secondary Outcomes (1)
Serologically-confirmed influenza infection (symptomatic or asymptomatic)
12 weeks
Study Arms (2)
Chloroquine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
Eligibility Criteria
You may qualify if:
- Age 18 -65
- Have the ability to provide informed consent
- If a woman of child-bearing potential, willing to use contraception for the period of the trial
You may not qualify if:
- Acute influenza-like illness at screening
- History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease
- Pregnancy or breast feeding
- Current use of medication with known serious hepatotoxic effects
- Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin
- Current severe depression (as indicated by current use of antidepressant medication)
- Known serious retinal disease
- Current or recent (within the past 30 days) participation in any other clinical intervention trial.
- Known G6PD deficiency
- Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigational Medicines Unit, National University Hospital
Singapore, 119074, Singapore
Related Publications (1)
Paton NI, Lee L, Xu Y, Ooi EE, Cheung YB, Archuleta S, Wong G, Wilder-Smith A. Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial. Lancet Infect Dis. 2011 Sep;11(9):677-83. doi: 10.1016/S1473-3099(11)70065-2. Epub 2011 May 5.
PMID: 21550310DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicholas I Paton, MD FRCP
National University of Singapore
- PRINCIPAL INVESTIGATOR
Lawrence Lee, MD PhD
National University of Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 28, 2010
First Posted
March 2, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
August 1, 2010
Last Updated
March 2, 2010
Record last verified: 2010-02