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The Chloroquine for Influenza Prevention Trial (CHIP)

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Chloroquine
Placebo
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Prevention, Chloroquine, Randomised controlled trial, Respiratory virus infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Investigational Medicines Unit, National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chloroquine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Laboratory-confirmed influenza-like illness

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2010
Last Updated
February 28, 2010
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01078779
Brief Title
The Chloroquine for Influenza Prevention Trial
Acronym
CHIP
Official Title
A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Prevention, Chloroquine, Randomised controlled trial, Respiratory virus infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloroquine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Chloroquine phosphate, Plaquenil
Intervention Description
Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
Primary Outcome Measure Information:
Title
Laboratory-confirmed influenza-like illness
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serologically-confirmed influenza infection (symptomatic or asymptomatic)
Description
Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas I Paton, MD FRCP
Organizational Affiliation
National University of Singapore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lawrence Lee, MD PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Medicines Unit, National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
21550310
Citation
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].
Results Reference
derived

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The Chloroquine for Influenza Prevention Trial

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