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Recruiting NCT05953233

School Inner City Air Study

No phase Interventional Viral Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active classroom HEPA cleaner, Sham classroom HEPA cleaner.
Who it may be relevant to
Registry conditions: Viral Infection. Basic parameters: 6 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Other Active classroom HEPA cleaner
    Commercially available portable HEPA cleaner
  • Other Sham classroom HEPA cleaner
    Commercially available portable HEPA cleaner with filtration device removed

Primary outcome measures

  • Viral pathogen detected in upper respiratory sample [Time frame: 1 year]
Secondary outcome measures (7)
  • Symptomatic respiratory infection (student, teacher) [Time frame: 1 year]
  • Symptomatic respiratory infection (household member) [Time frame: 1 year]
  • Viral detection in classroom bioaerosol sample [Time frame: 1 year]
  • Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report [Time frame: 1 year]
  • Severity of a cold in adult using the WURSS-24 [Time frame: 1 year]
  • Number of missed school or work days in last 30 days [Time frame: 1 year]
  • Number of days requiring inpatient or outpatient care in last 30 days [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Mass General Brigham — Boston

Identifiers

NCT: NCT05953233 · IRB-P00045373 · R21AI178155

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗