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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01078779 |
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Date of registration:
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28/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Chloroquine for Influenza Prevention Trial
CHIP |
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Scientific title:
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A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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1516 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01078779 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Lawrence Lee, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University, Singapore |
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Name:
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Nicholas I Paton, MD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University, Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Drug: Chloroquine
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Drug: Placebo
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Primary Outcome(s)
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Laboratory-confirmed influenza-like illness
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Serologically-confirmed influenza infection (symptomatic or asymptomatic)
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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