Clinical trial NCT05953233: School Inner City Air Study
Official title: School Inner City Air Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Viral Infection
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2023-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Viral pathogen detected in upper respiratory sample
timeFrame: 1 year
Secondary outcomes:
measure: Symptomatic respiratory infection (student, teacher)
timeFrame: 1 year
measure: Symptomatic respiratory infection (household member)
timeFrame: 1 year
measure: Viral detection in classroom bioaerosol sample
timeFrame: 1 year
measure: Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report
timeFrame: 1 year
measure: Severity of a cold in adult using the WURSS-24
timeFrame: 1 year
measure: Number of missed school or work days in last 30 days
timeFrame: 1 year
measure: Number of days requiring inpatient or outpatient care in last 30 days
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: