The Chloroquine for Influenza Prevention Trial

NCT ID: NCT01078779

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

1516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chloroquine

Group Type EXPERIMENTAL

Chloroquine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks

Interventions

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Chloroquine

Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks

Intervention Type DRUG

Placebo

Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks

Intervention Type DRUG

Other Intervention Names

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Chloroquine phosphate Plaquenil

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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National University of Singapore

Principal Investigators

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Nicholas I Paton, MD FRCP

Role: STUDY_CHAIR

National University of Singapore

Lawrence Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

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Investigational Medicines Unit, National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type DERIVED
PMID: 21550310 (View on PubMed)

Other Identifiers

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E/09/482

Identifier Type: -

Identifier Source: org_study_id

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