School Inner City Air Study

NCT05953233 | Recruiting

• 2 other identifiers: IRB-P00045373R21AI178155
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Viral Infection

Outcome Measures

Primary Outcomes (1)

• Viral pathogen detected in upper respiratory sample

  Presence/absence of a respiratory virus in upper respiratory sample

  1 year

Secondary Outcomes (7)

• Symptomatic respiratory infection (student, teacher)

  1 year

• Symptomatic respiratory infection (household member)

  1 year

• Viral detection in classroom bioaerosol sample

  1 year

• Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report

  1 year

• Severity of a cold in adult using the WURSS-24

  1 year

Study Arms (2)

Active HEPA cleaner

EXPERIMENTAL

Active HEPA cleaners will be placed in classrooms throughout the school year

Other: Active classroom HEPA cleaner

Sham HEPA cleaner

PLACEBO COMPARATOR

Sham HEPA cleaners will be placed in classrooms throughout the school year

Other: Sham classroom HEPA cleaner

Interventions

Active classroom HEPA cleaner OTHER

Commercially available portable HEPA cleaner

Active HEPA cleaner

Sham classroom HEPA cleaner OTHER

Commercially available portable HEPA cleaner with filtration device removed

Sham HEPA cleaner

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston Children's Hospital: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Peggy Lai, MD MPH

CONTACT

617-875-9878; plai@mgh.harvard.edu

Wanda Phipatanakul, MD MS

CONTACT

857-218-5336; wanda.phipatanakul@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Sham cleaners are constructed by removing the filters from air cleaners and adding a sound generator rendering them indistinguishable from active HEPA cleaners.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 20, 2023
• Study Start: September 15, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)