Health TrialsbyHealthPanel

School Inner City Air Study

ConditionViral Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-90
SponsorMassachusetts General Hospital

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active classroom HEPA cleaner

    Other intervention

    Commercially available portable HEPA cleaner

  • Sham classroom HEPA cleaner

    Other intervention

    Commercially available portable HEPA cleaner with filtration device removed

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Active HEPA cleanerExperimental treatment 1 intervention
Group B: Sham HEPA cleanerPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Viral pathogen detected in upper respiratory sample

Presence/absence of a respiratory virus in upper respiratory sample

Time frame
1 year

Secondary outcomes

1

Symptomatic respiratory infection (student, teacher)

Presence/absence of a cold based on 30 day recall

Time frame
1 year
2

Symptomatic respiratory infection (household member)

Presence/absence of a cold based on 30 day recall

Time frame
1 year
3

Viral detection in classroom bioaerosol sample

Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Boston Children's Hospital

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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