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The Chloroquine for Influenza Prevention Trial (CHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01078779
Recruitment Status : Unknown
Verified February 2010 by National University Hospital, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2010
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
National University Hospital, Singapore

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Laboratory-confirmed influenza-like illness [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Serologically-confirmed influenza infection (symptomatic or asymptomatic) [ Time Frame: 12 weeks ]
    Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078779


Locations
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Singapore
Investigational Medicines Unit, National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Study Chair: Nicholas I Paton, MD FRCP National University of Singapore
Principal Investigator: Lawrence Lee, MD PhD National University of Singapore
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Nicholas Paton, National University of Singapore
ClinicalTrials.gov Identifier: NCT01078779    
Other Study ID Numbers: E/09/482
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: February 2010
Keywords provided by National University Hospital, Singapore:
Influenza
Prevention
Chloroquine
Randomised controlled trial
Respiratory virus infection
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
 Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics