Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial

Mohammad Alfelali^{1

2}, Elizabeth A Haworth³, Osamah Barasheed^{1

4}, Al-Mamoon Badahdah^{1

2}, Hamid Bokhary^{5

6}, Mohamed Tashani^{7

8}, Mohammad I Azeem¹, Jen Kok^{5

9}, Janette Taylor⁹, Elizabeth H Barnes¹⁰, Haitham El Bashir¹¹, Gulam Khandaker^{7

12}, Edward C Holmes⁵, Dominic E Dwyer^{5

9}, Leon G Heron¹, Godwin J Wilson¹³, Robert Booy^{1

5}, Harunor Rashid^{1

5}; Hajj Research Team

Affiliations

¹ National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.
² Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia.
³ Menzies Institute for Medical Research Tasmania, Hobart, Tasmania, Australia.
⁴ Research Center, King Abdullah Medical City, Mecca, Saudi Arabia.
⁵ Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Umm Al-Qura University, Mecca, Saudi Arabia.
⁷ Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Faculty of Medicine, The University of Tripoli, Ain Zara, Tripoli, Libya.
⁹ NSW Health Pathology - Institute for Clinical Pathology and Medical Research, Westmead Hospital and The University of Sydney, Sydney, New South Wales, Australia.
¹⁰ NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ Rehabilitation Department, Al Jalila Children Specialty Hospital, Dubai, United Arab Emirates.
¹² Central Queensland Public Health Unit, Central Queensland Hospital and Health Service, Rockhampton, Queensland, Australia.
¹³ Department of Laboratory Medicine, Hamad Medical Corporation, Doha, Qatar.

PMID: 33048964
PMCID: PMC7553311
DOI: 10.1371/journal.pone.0240287

Randomized Controlled Trial

Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial

Mohammad Alfelali et al. PLoS One. 2020.

. 2020 Oct 13;15(10):e0240287.

doi: 10.1371/journal.pone.0240287. eCollection 2020.

Authors

Affiliations

¹ National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.
² Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia.
³ Menzies Institute for Medical Research Tasmania, Hobart, Tasmania, Australia.
⁴ Research Center, King Abdullah Medical City, Mecca, Saudi Arabia.
⁵ Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Umm Al-Qura University, Mecca, Saudi Arabia.
⁷ Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Faculty of Medicine, The University of Tripoli, Ain Zara, Tripoli, Libya.
⁹ NSW Health Pathology - Institute for Clinical Pathology and Medical Research, Westmead Hospital and The University of Sydney, Sydney, New South Wales, Australia.
¹⁰ NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ Rehabilitation Department, Al Jalila Children Specialty Hospital, Dubai, United Arab Emirates.
¹² Central Queensland Public Health Unit, Central Queensland Hospital and Health Service, Rockhampton, Queensland, Australia.
¹³ Department of Laboratory Medicine, Hamad Medical Corporation, Doha, Qatar.

PMID: 33048964
PMCID: PMC7553311
DOI: 10.1371/journal.pone.0240287

Abstract

Background: In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections.

Methods and results: Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06).

Conclusion: This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.

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Conflict of interest statement

Professor Robert Booy has received funding from Baxter, CSL, GSK, Merck, Novartis, Pfizer, Roche, Romark and Sanofi Pasteur for conducting research other than this, 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.

Figures

**Fig 2. Proportion of facemask using participants by the duration of mask use across the study arms.**
(This stacked bar chart shows the proportion by subgroup of recorded time of daily facemask use in the intervention group was consistently greater than in the control group).

**Fig 3. Reasons for not using facemasks across the study arms.**

See this image and copyright information in PMC

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Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial

Affiliations

Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources