School Inner City Air Study

Mass General Brigham

Status: Enrolling

Conditions: Viral Infection

Treatments: Other: Sham classroom HEPA cleaner; Other: Active classroom HEPA cleaner

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05953233

R21AI178155 (U.S. NIH Grant/Contract)

IRB-P00045373

Details and patient eligibility

About

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?

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Active HEPA cleaner

Experimental group

Description:

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

Treatment:

Other: Active classroom HEPA cleaner

Sham HEPA cleaner

Placebo Comparator group

Description:

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

Treatment:

Other: Sham classroom HEPA cleaner