InfluenzaPhase 2CHIPNCT01078779
The Chloroquine for Influenza Prevention Trial
A Phase 2 study testing Chloroquine in people with Influenza, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,516 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Investigational Medicines Unit, National University Hospital
Singapore, 119074
About this study
Official title: 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
- Conditions
- Influenza
- Being tested
- Chloroquine, Placebo
- Keywords
- Influenza, Prevention, Chloroquine, Randomised controlled trial, Respiratory virus infection
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called Chloroquine phosphate, Plaquenil
Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
PlaceboDrug
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine | Experimental | Not described Receives: Drug: Chloroquine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed influenza-like illness
Measured: 12 weeks
Secondary outcomes (1)
Serologically-confirmed influenza infection (symptomatic or asymptomatic)
Four-fold rise in influenza antibody titre at week 12 compared to the baseline sample
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Nicholas I Paton, MD FRCP, Study chair, National University of SingaporeLawrence Lee, MD PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078779
- Sponsor's protocol ID
- E/09/482
- Acronym
- CHIP
- Status last verified
- Feb 2010
- First submitted
- 28 Feb 2010
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21550310
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
- ClinicalTrials.gov ID
- NCT01078779
- Acronym / sponsor ID
- CHIP / E/09/482
- Conditions
- Influenza
- Keywords
- Influenza, Prevention, Chloroquine, Randomised controlled trial, Respiratory virus infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,516 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine | Experimental | Drug: Chloroquine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: Chloroquine phosphate, PlaquenilChloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks | Drug | Chloroquine |
| PlaceboPlacebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks | Drug | Placebo |
Primary outcome
Laboratory-confirmed influenza-like illness
Time frame: 12 weeks
1 secondary outcome
Serologically-confirmed influenza infection (symptomatic or asymptomatic)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 21550310Paton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas I Paton, MD FRCP study chair
National University of Singapore
Lawrence Lee, MD PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloroquine in people with Influenza, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory-confirmed influenza-like illness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01078779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.