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Trial registered on ANZCTR


Registration number
ACTRN12613001018707
Ethics application status
Approved
Date submitted
9/09/2013
Date registered
12/09/2013
Date last updated
12/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster-randomised controlled trial to test the effectiveness of facemasks in preventing respiratory virus infection among Hajj pilgrims
Scientific title
Cluster-randomised controlled trial to test the effectiveness of facemasks in preventing respiratory virus infection among Hajj pilgrims
Secondary ID [1] 283015 0
‘Nil known’
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventing respiratory viral infection at Hajj 289843 0
Condition category
Condition code
Public Health 290199 290199 0 0
Epidemiology
Infection 290426 290426 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that we will use it for this study is ‘3M 'Trademark' Standard Tie-On Surgical Mask, Cat No: 1816’.

Masks will be provided to intervention group ‘mask tents’ to use it during the Hajj week in 2013 and 2014 (ie 13-18 October 2013 and 2-9 October 2014). Study staff will practically demonstrate the correct method of how to wear masks and help pilgrims to put on their mask for the first time. Each participant will be provided with 5 masks per day and a brochure with instructions about mask wearing and usage. The medical researchers will follow them each day to reminding them about recording their mask usage in a health diary.
Intervention code [1] 287915 0
Prevention
Comparator / control treatment
No use of facemask
Control group
Active

Outcomes
Primary outcome [1] 290425 0
Any pilgrim develop subjective fever and one symptom of influenza-like illness e.g. cough.

A medical research team member will be available each morning and evening to distribute additional facemasks should pilgrims request extra, and to document any reported influenza-like illness symptoms development.
Timepoint [1] 290425 0
From day 3 until day 7 after the randomisation (13 October 2013 and 2 October 2014).
Secondary outcome [1] 304499 0
Laboratory proven respiratory viral infection.

During the Hajj week study team members will collect nasopharyngeal (NP) swab (or throat swab if an NP swab is not doable) for reverse transcriptase polymerase chain reaction (RT-PCR) analysis of respiratory virus infection. The swab used will be 'Copan nylon flocked dry nasal swab'. The study staff who will take the swab will all have been trained to achieve an appropriate sample.
Timepoint [1] 304499 0
One week from the randomisation.

Eligibility
Key inclusion criteria
Pilgrims from participating countries staying in their respective tents.
Any gender, aged >/= 16 years.
Informed consent has been agreed and signed.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children aged less than 16 years.
Participation in another clinical trial investigating a medical intervention.
Known contraindication to mask use (eg, allergy to surgical mask materials).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation to each arm will be in a 1:1 ratio and will be done according to tents. The randomisation will be stratified by gender and country of residence to ensure a balanced and proportionate recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers will be made by an offsite research coordinator who will not take part in recruitment or assessment of participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Assuming that the prevalence of symptomatic RTIs is 30% in the controls and the prevalence of laboratory-proven respiratory viral infection in controls is approximately 12% the intervention could be considered clinically worthwhile if it can reduce the prevalence of syndromic or proven viral RTI by 50%.
Assuming a moderate intra-cluster correlation of 10% and a mean of 75 participants per cluster (tent), and inflating the sample by a factor of 8.4 to account for clustering, the sample size required for a cRCT to detect a reduction from 12% to 6% with 80% power at 5% significance is 2976 per arm. An additional inflation factor of 1.18 will allow for up to 15% loss to follow-up or incomplete outcome data. This results in a sample size of approximately 3500 participants per treatment making a total of 7000.
For the first primary outcome (clinical/syndromic RTIs) a smaller sample would be sufficient to answer a more generic question, namely prevention of symptomatic RTI. The sample size required for detecting a reduction from 30% prevalence of RTIs to 15% with 80% power at 5% significance and considering for clustering and loss to follow-up is about 1170 participants per treatment making a total of 2340.
To achieve the full sample size we aim to conduct the study over two years (2013 and 2014). About 2500 pilgrims (or at least 2340) will be recruited in 2013 which will give an answer for the RTI outcome and could build on that sample for the second outcome (proven infection) which ultimately will be completed by recruiting another 4500 pilgrims in 2014.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5396 0
Saudi Arabia
State/province [1] 5396 0
Makkah

Funding & Sponsors
Funding source category [1] 287916 0
Government body
Name [1] 287916 0
Qatar National Research Fund, member of Qatar Foundation.
Address [1] 287916 0
Qatar National Research Fund
Qatar Foundation
P.O. Box 5825
Doha Qatar
Country [1] 287916 0
Qatar
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead, National Centre for Immunisation Research and Surveillance (NCIRS)
Address
Cnr Hawkesbury Rd & Hainsworth St, Locked bag 4001, Westmead NSW 2145, Australia.
Country
Australia
Secondary sponsor category [1] 286644 0
Government body
Name [1] 286644 0
Public Health Directorate at Ministry of Health in Saudi Arabia.
Address [1] 286644 0
Ministry of Health
Kingdom of Saudi Arabia

Riyadh - Postal Code: 11176
Country [1] 286644 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289855 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289855 0
Research Ethics and Governance Unit
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305

Ethics committee country [1] 289855 0
Australia
Date submitted for ethics approval [1] 289855 0
28/06/2013
Approval date [1] 289855 0
17/07/2013
Ethics approval number [1] 289855 0
HREC/13/HNE/265

Summary
Brief summary
This study will be a large scale cluster randomised controlled trial to test the effectiveness of facemasks in preventing acute respiratory viral infection including influenza and coronaviruses.
The trial will compare the ‘use of (simple surgical) facemasks’ versus ‘no use of facemasks’ among pilgrims during the Hajj week (13 to 20 October, 2013, and 2 to 9 October 2014). Randomisation to each arm will be in a 1:1 ratio and will be done according to tents.

For the intervention tents free masks will be provided to each person to be worn continuously for at least 5 days of
stay at Mina. They will be given two diaries to record their flu-like symptoms and history of mask use.

Data available from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use
makes a significant difference in reducing the frequency of laboratory confirmed respiratory virus infection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42138 0
Dr Harunor Rashid
Address 42138 0
National Centre for Immunisation Research and Surveillance (NCIRS), The Children’s Hospital at Westmead.

Cnr Hawkesbury Rd & Hainsworth St,
Westmead NSW 2145
Country 42138 0
Australia
Phone 42138 0
+61 2 9845 1489
Fax 42138 0
+61 2 9845 1418
Email 42138 0
harunor.rashid@health.nsw.gov.au
Contact person for public queries
Name 42139 0
Prof Robert Booy
Address 42139 0
National Centre for Immunisation Research and Surveillance (NCIRS), The Children’s Hospital at Westmead.

Cnr Hawkesbury Rd & Hainsworth St,
Westmead NSW 2145
Country 42139 0
Australia
Phone 42139 0
+61 2 9845 1402
Fax 42139 0
Email 42139 0
robert.booy@health.nsw.gov.au
Contact person for scientific queries
Name 42140 0
Dr Harunor Rashid
Address 42140 0
National Centre for Immunisation Research and Surveillance (NCIRS), The Children’s Hospital at Westmead.

Cnr Hawkesbury Rd & Hainsworth St,
Westmead NSW 2145
Country 42140 0
Australia
Phone 42140 0
+61 2 9845 1489
Fax 42140 0
Email 42140 0
harunor.rashid@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results