Overview

This trial is active, not recruiting.

Condition influenza
Treatments chloroquine, placebo
Phase phase 2
Sponsor National University Hospital, Singapore
Start date November 2009
End date May 2010
Trial size 1516 participants
Trial identifier NCT01078779, E/09/482

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
chloroquine Chloroquine phosphate
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 Comparator)
placebo
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks

Primary Outcomes

Measure
Laboratory-confirmed influenza-like illness
time frame: 12 weeks

Secondary Outcomes

Measure
Serologically-confirmed influenza infection (symptomatic or asymptomatic)
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
Principal investigator Lawrence Lee, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by National University Hospital, Singapore.