Viral Infection
Conditions
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).
Interventions
OTHERActive classroom HEPA cleaner
Commercially available portable HEPA cleaner
OTHERSham classroom HEPA cleaner
Commercially available portable HEPA cleaner with filtration device removed
Sponsors
Boston Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Sham cleaners are constructed by removing the filters from air cleaners and adding a sound generator rendering them indistinguishable from active HEPA cleaners.
Intervention model description
Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
Eligibility
Sex/Gender
ALL
Age
6 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral pathogen detected in upper respiratory sample | 1 year | Presence/absence of a respiratory virus in upper respiratory sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic respiratory infection (household member) | 1 year | Presence/absence of a cold based on 30 day recall |
| Viral detection in classroom bioaerosol sample | 1 year | Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air) |
| Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report | 1 year | 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. |
| Symptomatic respiratory infection (student, teacher) | 1 year | Presence/absence of a cold based on 30 day recall |
| Number of missed school or work days in last 30 days | 1 year | 30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe. |
| Number of days requiring inpatient or outpatient care in last 30 days | 1 year | 30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe. |
| Severity of a cold in adult using the WURSS-24 | 1 year | Severity of a cold (when present) in adult will be graded using the Wisconsin Upper Respiratory Symptom Survey 24 Daily Symptom Report (WURSS-24). Range 0 - 161; higher indicates more severe. |
Countries
United States
Contacts
Primary ContactPeggy Lai, MD MPH
Backup ContactWanda Phipatanakul, MD MS
Outcome results
None listed