search
Back to results

School Inner City Air Study

Primary Purpose

Viral Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active classroom HEPA cleaner
Sham classroom HEPA cleaner
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Viral Infection

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Active HEPA cleaner

    Sham HEPA cleaner

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Viral pathogen detected in upper respiratory sample
    Presence/absence of a respiratory virus in upper respiratory sample

    Secondary Outcome Measures

    Symptomatic respiratory infection (student, teacher)
    Presence/absence of a cold based on 30 day recall
    Symptomatic respiratory infection (household member)
    Presence/absence of a cold based on 30 day recall
    Viral detection in classroom bioaerosol sample
    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
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 27, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Boston Children's Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05953233
    Brief Title
    School Inner City Air Study
    Official Title
    School Inner City Air Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    August 2029 (Anticipated)
    Study Completion Date
    August 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Boston Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viral Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
    Masking
    ParticipantCare ProviderOutcomes 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.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active HEPA cleaner
    Arm Type
    Experimental
    Arm Description
    Active HEPA cleaners will be placed in classrooms throughout the school year
    Arm Title
    Sham HEPA cleaner
    Arm Type
    Placebo Comparator
    Arm Description
    Sham HEPA cleaners will be placed in classrooms throughout the school year
    Intervention Type
    Other
    Intervention Name(s)
    Active classroom HEPA cleaner
    Intervention Description
    Commercially available portable HEPA cleaner
    Intervention Type
    Other
    Intervention Name(s)
    Sham classroom HEPA cleaner
    Intervention Description
    Commercially available portable HEPA cleaner with filtration device removed
    Primary Outcome Measure Information:
    Title
    Viral pathogen detected in upper respiratory sample
    Description
    Presence/absence of a respiratory virus in upper respiratory sample
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Symptomatic respiratory infection (student, teacher)
    Description
    Presence/absence of a cold based on 30 day recall
    Time Frame
    1 year
    Title
    Symptomatic respiratory infection (household member)
    Description
    Presence/absence of a cold based on 30 day recall
    Time Frame
    1 year
    Title
    Viral detection in classroom bioaerosol sample
    Description
    Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)
    Time Frame
    1 year
    Title
    Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report
    Description
    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
    Title
    Severity of a cold in adult using the WURSS-24
    Description
    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.
    Time Frame
    1 year
    Title
    Number of missed school or work days in last 30 days
    Description
    30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.
    Time Frame
    1 year
    Title
    Number of days requiring inpatient or outpatient care in last 30 days
    Description
    30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peggy Lai, MD MPH
    Phone
    617-875-9878
    Email
    plai@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wanda Phipatanakul, MD MS
    Phone
    857-218-5336
    Email
    wanda.phipatanakul@childrens.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The data will be made openly available through BioLINCC consistent with privacy and informed consent. As above, released individual-level data will not include information that alone or in conjunction with other data could readily identify individual participants. These data will be summarized and aggregated before sharing in BioLINCC. Data from research participants who refused to permit data sharing will be removed from the repository data set. All study data will be preserved as per study consents.

    Learn more about this trial

    School Inner City Air Study

    We'll reach out to this number within 24 hrs