The Chloroquine for Influenza Prevention Trial

Influenza Clinical Trial

— CHIP  

Official title:

A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01078779
• Other study ID #: E/09/482
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 28, 2010
• Last updated: February 28, 2010
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2010
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1516
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• Placebo
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks

Locations

Country	Name	City	State
Singapore	Investigational Medicines Unit, National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory-confirmed influenza-like illness		12 weeks	No
Secondary	Serologically-confirmed influenza infection (symptomatic or asymptomatic)	Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample	12 weeks	No