School Inner City Air Study

The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are:

• Do classroom HEPA cleaners reduce exposure to viruses?
• Do classroom HEPA cleaners reduce student and teacher infections?
• Do classroom HEPA cleaners reduce infections in family members?

Study Overview

• Status: Not yet recruiting
• Conditions: Viral Infection
• Intervention / Treatment: Other: Active classroom HEPA cleaner; Other: Sham classroom HEPA cleaner

Detailed Description

Classrooms from participating schools will be randomized to active vs. sham HEPA cleaners. From enrolled classrooms, we will enroll students, teachers, and members of the household. We will collect the following:

• longitudinal classroom air samples
• longitudinal upper respiratory samples
• longitudinal symptom surveys using the Wisconsin Upper Respiratory Symptom Survey (WURSS) Viral testing on collected air and respiratory samples will be performed using digital polymerase chain reaction (dPCR).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peggy Lai, MD MPH; Phone Number: 617-875-9878; Email: plai@mgh.harvard.edu
• Study Contact Backup: Name: Wanda Phipatanakul, MD MS; Phone Number: 857-218-5336; Email: wanda.phipatanakul@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Children

• Grades K-5 (age 6-12 years)
• Attend one of the schools that the study team has permission to obtain classroom/school environmental samples
• Have no plans to move schools within the upcoming 12 months
• Subject and/or parent guardian must be able to understand and provide informed consent and also willing to participate in the study

Adults

• Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study
• Able to understand and provide informed consent

Exclusion Criteria:

Children

• Contraindication to or inability to participate in home self-collection of nasal swab samples
• Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
• Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
• Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Adults

• Contraindication to or inability to participate in home self-collection of nasal swab samples
• Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
• Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
• Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active HEPA cleaner; Active HEPA cleaners will be placed in classrooms throughout the school year	Other: Active classroom HEPA cleaner; Commercially available portable HEPA cleaner
Placebo Comparator: Sham HEPA cleaner; Sham HEPA cleaners will be placed in classrooms throughout the school year	Other: Sham classroom HEPA cleaner; Commercially available portable HEPA cleaner with filtration device removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral pathogen detected in upper respiratory sample	Presence/absence of a respiratory virus in upper respiratory sample	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic respiratory infection (student, teacher)	Presence/absence of a cold based on 30 day recall	1 year
Symptomatic respiratory infection (household member)	Presence/absence of a cold based on 30 day recall	1 year
Viral detection in classroom bioaerosol sample	Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)	1 year
Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report	Severity of a cold (when present) in child will be graded using the Wisconsin Upper Respiratory Symptom Survey Kids Daily Symptom Report (WURSS-K). Range 0 - 42; higher indicates more severe.	1 year
Severity of a cold in adult using the WURSS-24	Severity of a cold (when present) in adult will be graded using the Wisconsin Upper Respiratory Symptom Survey 24 Daily Symptom Report (WURSS-24). Range 0 - 161; higher indicates more severe.	1 year
Number of missed school or work days in last 30 days	30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.	1 year
Number of days requiring inpatient or outpatient care in last 30 days	30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe.	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: IRB-P00045373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be made openly available through BioLINCC consistent with privacy and informed consent. As above, released individual-level data will not include information that alone or in conjunction with other data could readily identify individual participants. These data will be summarized and aggregated before sharing in BioLINCC. Data from research participants who refused to permit data sharing will be removed from the repository data set. All study data will be preserved as per study consents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No