The Chloroquine for Influenza Prevention Trial (CHIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National University Hospital, Singapore.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01078779
First received: February 28, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 28, 2010
February 28, 2010
November 2009
May 2010   (final data collection date for primary outcome measure)
Laboratory-confirmed influenza-like illness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Serologically-confirmed influenza infection (symptomatic or asymptomatic) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample
Same as current
Not Provided
Not Provided
 
The Chloroquine for Influenza Prevention Trial
A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • 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
  • Drug: Placebo
    Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
  • Experimental: Chloroquine
    Intervention: Drug: Chloroquine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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. Erratum in: Lancet Infect Dis. 2011 Sep;11(9):655. Smith, Annelies Wilder [corrected to Wilder-Smith, Annelies].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1516
August 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01078779
E/09/482
Yes
Professor Nicholas Paton, National University of Singapore
National University Hospital, Singapore
Not Provided
Study Chair: Nicholas I Paton, MD FRCP National University, Singapore
Principal Investigator: Lawrence Lee, MD PhD National University, Singapore
National University Hospital, Singapore
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP