lancet-header
Preprints with The Lancet is part of SSRN´s First Look, a place where journals and other research experts identify content of interest prior to publication. These preprint papers are not peer-reviewed and are posted here as part of a 12-month trial. Authors have either opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet, or submitted directly via SSRN. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. These papers should not be used for clinical decision making or reporting of research to a lay audience without indicating that this is preliminary research that has not been peer-reviewed. For more information see the Comment published in The Lancet, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com

Facemask versus No Facemask in Preventing Viral Respiratory Infections During Hajj: A Cluster Randomised Open Label Trial

50 Pages Posted: 11 Mar 2019

See all articles by Mohammad Alfelali

Mohammad Alfelali

National Centre for Immunisation Research and Surveillance

Elizabeth Ann Haworth

University of Tasmania - Menzies Institute for Medical Research

Osamah Barasheed

National Centre for Immunisation Research and Surveillance

Al-Mamoon Badahdah

National Centre for Immunisation Research and Surveillance

Hamid Bokhary

The University of Sydney - Sydney Medical School

Mohamed Tashani

The University of Sydney - Discipline of Child and Adolescent Health

Mohammad Irfan Azeem

National Centre for Immunisation Research and Surveillance

Jen Kok

The University of Sydney - Sydney Medical School

Janette Taylor

The University of Sydney - Sydney Medical School

Elizabeth Helen Barnes

The University of Sydney - Faculty of Medicine and Health

Haitham El Bashir

Al Jalila Children Specialty Hospital

Gulam Khandaker

The University of Sydney - Sydney Medical School

Edward Charles Holmes

The University of Sydney - Sydney Medical School

Dominic Edmund Dwyer

The University of Sydney - Sydney Medical School

Leon Heron

National Centre for Immunisation Research and Surveillance

Godwin Justus Wilson

Hamad Medical Corporation

Robert Booy

University of Sydney - National Centre for Immunisation Research and Surveillance

Harunor Rashid

National Centre for Immunisation Research and Surveillance; Children’s Hospital at Westmead; The University of Sydney

More...

Abstract

Background: This large-scale cluster-randomised controlled trial (cRCT) evaluated use of facemasks against laboratory-confirmed viral respiratory tract infections (vRTIs) and clinical respiratory infection (CRI) because previous studies have been inconclusive.

Methods: An open label cRCT, conducted in Makkah compared the offer and use of 50 surgical facemasks worn over five days versus no facemasks among pilgrims. Cluster-randomisation was by accommodation tents stratified by country and gender. Tents were allocated to groups by coin-tossing. Neither participants nor recruiting investigators could be blinded to the intervention. Facemask use and respiratory symptoms were recorded daily and nasal/pharyngeal swabs were collected from symptomatic participants for detection of respiratory viruses. Clinical and laboratory data were analysed for facemask efficacy against laboratory-confirmed vRTIs and CRI. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001018707.

Findings: From October 13 to 17 in 2013, October 2 to 6 in 2014, and September 22 to 26 in 2015, 7,687 adult participants from 318 tents were randomised to facemasks or no facemasks; 3,864 participants from 149 tents were assigned to the Facemask group and 3,823 participants from 169 tents to the Control group. In the Facemask arm, respectively 27% and 51% participants used facemasks daily and intermittently, 22% did not; in the Control arm, respectively 15% and 38% participants used facemasks daily and intermittently, 47% did not. Respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs from symptomatic pilgrims. In intention-to-treat analysis, facemask use was neither effective against laboratory-confirmed vRTIs (OR 1.35, 95% CI 0.88-2.07) nor against CRI (OR 1.1, 95% CI 0.88-1.39), not even in per-protocol analysis (OR 1.2, 95% CI 0.87-1.69; OR 1.3, 95% CI 0.99-1.83).

Interpretation: Facemask use does not prevent clinical or laboratory-confirmed viral respiratory infections among Hajj pilgrims.

Funding: Qatar National Research Fund (number: NPRP 6-1505-3-358).

Declaration of Interest: Professor Robert Booy has received funding from Baxter, CSL, GSK, Merck, Novartis, Pfizer, Roche, Romark and Sanofi Pasteur for conducting this research, travel to conferences or consultancy work; all funding received is directed to research accounts at The Children’s Hospital at Westmead. Dr Harunor Rashid has received fees from Pfizer, Sanofi Pasteur and Novartis for consulting or serving on an advisory board. The other authors have no competing interests to declare.

Ethical Approval: The trial has received approval from an Australian Human Research Ethics Committee (NSW HREC Ref: HREC/13/HNE/265), and the Joint Institutional Review Board (J-IRB) of Hamad Medical Corporation - Weill Cornell Medical College in Qatar (IRB Number: 13-00039).

Keywords: Cluster randomised controlled trial; Facemask; Hajj; Pilgrim; Viral respiratory infection

Suggested Citation

Alfelali, Mohammad and Haworth, Elizabeth Ann and Barasheed, Osamah and Badahdah, Al-Mamoon and Bokhary, Hamid and Tashani, Mohamed and Azeem, Mohammad Irfan and Kok, Jen and Taylor, Janette and Barnes, Elizabeth Helen and El Bashir, Haitham and Khandaker, Gulam and Holmes, Edward Charles and Dwyer, Dominic Edmund and Heron, Leon and Wilson, Godwin Justus and Booy, Robert and Rashid, Harunor, Facemask versus No Facemask in Preventing Viral Respiratory Infections During Hajj: A Cluster Randomised Open Label Trial (March 8, 2019). Available at SSRN: https://ssrn.com/abstract=3349234 or http://dx.doi.org/10.2139/ssrn.3349234

Mohammad Alfelali

National Centre for Immunisation Research and Surveillance

Australia

Elizabeth Ann Haworth

University of Tasmania - Menzies Institute for Medical Research

Australia

Osamah Barasheed

National Centre for Immunisation Research and Surveillance

Australia

Al-Mamoon Badahdah

National Centre for Immunisation Research and Surveillance

Australia

Hamid Bokhary

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Mohamed Tashani

The University of Sydney - Discipline of Child and Adolescent Health

Sydney
Australia

Mohammad Irfan Azeem

National Centre for Immunisation Research and Surveillance

Australia

Jen Kok

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Janette Taylor

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Elizabeth Helen Barnes

The University of Sydney - Faculty of Medicine and Health

Sydney, New South Wales 2006
Australia

Haitham El Bashir

Al Jalila Children Specialty Hospital

Dubai
United Arab Emirates

Gulam Khandaker

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Edward Charles Holmes

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Dominic Edmund Dwyer

The University of Sydney - Sydney Medical School

Edward Ford Building A27
The University of Sydney
Sydney, New South Wales NSW 2006
Australia

Leon Heron

National Centre for Immunisation Research and Surveillance

Australia

Godwin Justus Wilson

Hamad Medical Corporation

Doha
Qatar

Robert Booy

University of Sydney - National Centre for Immunisation Research and Surveillance

Australia

Harunor Rashid (Contact Author)

National Centre for Immunisation Research and Surveillance ( email )

Australia

Children’s Hospital at Westmead ( email )

Westmead
Australia

The University of Sydney ( email )

University of Sydney
Sydney, NSW 2006
Australia

Click here to go to TheLancet.com

Paper statistics

Abstract Views
527
Downloads
90