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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
  Purpose

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


Condition Intervention Phase
Influenza
 Drug: Chloroquine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Laboratory-confirmed influenza-like illness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 1516
Study Start Date: November 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078779

Locations
Singapore
Investigational Medicines Unit, National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Study Chair: Nicholas I Paton, MD FRCP National University, Singapore
Principal Investigator: Lawrence Lee, MD PhD National University, Singapore
  More Information

No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Nicholas Paton, National University of Singapore
ClinicalTrials.gov Identifier: NCT01078779     History of Changes
Other Study ID Numbers: E/09/482
Study First Received: February 28, 2010
Last Updated: February 28, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Influenza
Prevention
Chloroquine
Randomised controlled trial
Respiratory virus infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013