CHIP: The Chloroquine for Influenza Prevention Trial

Sponsor

National University Hospital, Singapore (Other)

Overall Status

Unknown status

CT.gov ID

NCT01078779

Collaborator

(none)

1,516

Enrollment

Location

Arms

Duration (Months)

169

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: Chloroquine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1516 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroquine	Drug: 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 Other Names: Chloroquine phosphate Plaquenil
Placebo Comparator: Placebo	Drug: Placebo Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks

Arm

Intervention/Treatment

Experimental: Chloroquine

Drug: 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

Other Names:

Chloroquine phosphate

Plaquenil

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Laboratory-confirmed influenza-like illness [12 weeks]

Secondary Outcome Measures

Serologically-confirmed influenza infection (symptomatic or asymptomatic) [12 weeks]
Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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