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The Chloroquine for Influenza Prevention Trial

Phase 2
Conditions
Influenza
Interventions
Drug: Placebo
Registration Number
NCT01078779
Lead Sponsor
National University Hospital, Singapore
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
1516
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
ChloroquineChloroquine-
Primary Outcome Measures
NameTimeMethod
Laboratory-confirmed influenza-like illness12 weeks
Secondary Outcome Measures
NameTimeMethod
Serologically-confirmed influenza infection (symptomatic or asymptomatic)12 weeks

Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample

Trial Locations

Locations (1)

Investigational Medicines Unit, National University Hospital

🇸🇬

Singapore, Singapore

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