ISRCTN ISRCTN46750688
DOI https://doi.org/10.1186/ISRCTN46750688
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number BTHFT 2662
Sponsor Bradford Teaching Hospitals NHS Foundation Trust
Funder UK Health Security Agency
Submission date
03/03/2022
Registration date
11/03/2022
Last edited
07/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The COVID-19 pandemic has wreaked havoc upon the education of a whole generation of school children. It is estimated that school children have lost at least a half of an academic year due to the pandemic. Education analysts have assessed the numbers of children achieving or exceeding the expected level for their age in reading, writing and maths compared with pre-pandemic scores.
Whilst rates of transmission of COVID-19 have dropped during the summer months there is a high risk that if no action is taken to mitigate airborne transmission, the risk of infection is likely to increase again in the autumn and winter seasons. The result being further school closures.
The aim of this study is to conduct an early phase trial of two air cleaning technologies with a focus on feasibility and practical implementation. The air cleaning technologies have the potential to mitigate the aerosol transmission of viral particles - including the SARS-CoV-2 virus - within schools. This study seeks to explore the practicalities and possible benefits of fitting schools with these technologies.

Who can participate?
The study will be conducted within 30 primary schools in Bradford, UK.

What does the study involve?
The study will have three arms: a control arm and two intervention arms; one with installation of portable high efficiency particulate air (HEPA) filter units, and the other with installation of germicidal ultraviolet (GUV) devices.

What are the possible benefits and risks of participating?
There is a potential benefit for children and staff within the schools with air cleaning technology (i.e. reduced infection from air bourne illness) but this remains to be determined. There are little to no risks associated with the research (the worse case scenario is a data breach that would reveal data – schools absences – that are already collected within the Local Authority).

Where is the study run from?
The study is run from the Centre for Applied Education Research which is based at the Bradford Teaching Hospitals NHS Foundation Trust, UK.

When is the study starting and how long is it expected to run for?
January 2021 to September 2022

Who is funding the study?
The study is funded by the Department for Health and Social Care (UK)

Who is the main contact?
Prof. Mark Mon-Williams, M.Mon-Williams@leeds.ac.uk

Contact information

Prof Mark Mon-Williams
Principal investigator

Centre for Apllied Education Research
Wolfson Centre for Applied Helath Research
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

ORCiD logoORCID ID 0000-0001-7595-8545
Phone +44 1274 36 6878
Email M.Mon-Williams@leeds.ac.uk

Study information

Primary study designInterventional
Study designMulti centre randomized controlled trial of environmental interventions
Secondary study designRandomised controlled trial
Participant information sheet 41288 PIS.pdf
Scientific titlePhase 1 trial of COVID-19 airborne transmission prevention technologies
Study acronymClass-ACT
Study objectivesAir Cleaning Technologies reduce the transmission of COVID-19 in school pupils and staff
Ethics approval(s)Approved 13/12/2021, School of Psychology Research Ethics Committee (School of Psychology, University of Leeds, LS2 9JT, UK; +44 113 343 5724; G.S.Finlayson@leeds.ac.uk), ref: PSYC-414
Health condition(s) or problem(s) studiedPrevention of COVID-19 transmission in school pupils and staff
InterventionThis study will be an early phase trial of two air cleaning technologies with a focus on feasibility and practical implementation. This study seeks to explore the practicalities and possible benefits of fitting schools with these technologies in order to mitigate the aerosol transmission of viral particles -including the SARS-CoV-2 virus. The study will be conducted within 30 primary schools in Bradford, UK.

The study will have three arms: a control arm and two intervention arms; one with the installation of portable high-efficiency particulate air (HEPA) filter units, and the other with the installation of germicidal ultraviolet (GUV) devices. Participating schools will be randomly allocated to each arm.

Randomisation process: Schools names were drawn from a bag

Intervention & follow up length: 1st August 2021 – 1st August 2022
Intervention typeDevice
PhaseNot Applicable
Drug / device / biological / vaccine name(s)portable high-efficiency particulate air (HEPA) filter units, germicidal ultraviolet (GUV) devices
Primary outcome measure(s)

School absences for COVID-19 measured using anonymised data contained in schools information management systems and relayed to Local Authority at weekly intervals

Key secondary outcome measure(s)

1. CO2, humidity, PM2.5 & PM10 levels in classrooms measured through air monitoring devices at 60 second intervals and relayed via API.
2. Power usage levels for HEPA devices measured through power consumption monitoring devices at 60 second intervals and relayed via API.
3. Primary and secondary Care level data will be collect via Connected Yorkshire data set at weekly intervals. The Connected Yorkshire programme links disparate routine electronic data in an anonymised database across primary care, secondary care, community care and social care for over 700,000 individuals at Bradford Teaching Hospitals NHS Foundation Trust.

Completion date30/09/2022

Eligibility

Participant type(s)Other
Age groupMixed
SexAll
Target sample size at registration30
Total final enrolment32
Key inclusion criteria1. Primary school
2. 5 - 11 year-old students
3. Naturally ventilated buildings
Key exclusion criteria1. Mechanically ventilated schools
2. Secondary schools
3. Further education establishments
Date of first enrolment01/06/2021
Date of final enrolment31/08/2021

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Centre for Applied Education Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository, Available on request
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in the non-publically available repository within the Bradford Institute of Health Research. The datasets generated during and/or analysed during the current study are/will be available upon request. (M.Mon-Williams@leeds.ac.uk)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 07/03/2022 No Yes
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Protocol file 07/03/2022 No No
Study website Study website 11/11/2025 11/11/2025 No Yes

Additional files

41288 PIS.pdf
Participant information sheet
41288 Protocol.pdf
Protocol file

Editorial Notes

07/03/2022: Trial's existence confirmed by Leeds School of Psychology Research Ethics Committee