The Chloroquine for Influenza Prevention Trial (CHIP)

February 28, 2010 updated by: National University Hospital, Singapore

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1516

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Investigational Medicines Unit, National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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:
  • Plaquenil
  • Chloroquine phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory-confirmed influenza-like illness
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Study Chair: Nicholas I Paton, MD FRCP, National University, Singapore
  • Principal Investigator: Lawrence Lee, MD PhD, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

February 28, 2010

First Submitted That Met QC Criteria

February 28, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 28, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E/09/482

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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