School Inner City Air Study

Viral Infection Clinical Trial

Official title:

School Inner City Air Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953233
• Other study ID #: IRB-P00045373
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: August 2030

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: Peggy Lai, MD MPH
• Phone: 617-875-9878
• Email: plai[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2030
• Est. primary completion date: August 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Viral Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral pathogen detected in upper respiratory sample	Presence/absence of a respiratory virus in upper respiratory sample	1 year
Secondary	Symptomatic respiratory infection (student, teacher)	Presence/absence of a cold based on 30 day recall	1 year
Secondary	Symptomatic respiratory infection (household member)	Presence/absence of a cold based on 30 day recall	1 year
Secondary	Viral detection in classroom bioaerosol sample	Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)	1 year
Secondary	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.	1 year
Secondary	Severity of a cold in adult using the WURSS-24	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.	1 year
Secondary	Number of missed school or work days in last 30 days	30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.	1 year
Secondary	Number of days requiring inpatient or outpatient care in last 30 days	30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe.	1 year