School Inner City Air Study | NCT05953233

Studies
School Inner City Air Study

NCT05953233

Sponsor

Massachusetts General Hospital

Status

Recruiting

Last Update Posted

Dec 11, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Viral Infection

Interventions

Active classroom HEPA cleaner
Sham classroom HEPA cleaner

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21AI178155	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2024Actual

Primary Completion Date

Aug 2029Estimated

Completion Date

Aug 2030Estimated

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jul 11, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 11, 2025Actual

Name	Class
Boston Children's Hospital	OTHER
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Active classroom HEPA cleaner	Other	Commercially available portable HEPA cleaner	Active HEPA cleaner

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
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

Facility	Status	City	State	ZIP	Country	Contacts
Mass General Brigham	Recruiting	Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided