Viral InfectionNCT05953233
School Inner City Air Study
A study testing Active classroom HEPA cleaner in people with Viral Infection, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Infection
- What is being tested?
- Active classroom HEPA cleaner
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Peggy Lai, MD MPH
About this study
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?
Read the 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).
- Conditions
- Viral Infection
- Being tested
- Active classroom HEPA cleaner, Sham classroom HEPA cleaner
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active classroom HEPA cleanerOther
Commercially available portable HEPA cleaner
Sham classroom HEPA cleanerOther
Commercially available portable HEPA cleaner with filtration device removed
| Study group | Role | What they receive |
|---|---|---|
| Active HEPA cleaner | Experimental | Active HEPA cleaners will be placed in classrooms throughout the school year Receives: Other: Active classroom HEPA cleaner |
| Sham HEPA cleaner | Placebo comparator | Sham HEPA cleaners will be placed in classrooms throughout the school year Receives: Other: Sham classroom HEPA cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral pathogen detected in upper respiratory sample
Presence/absence of a respiratory virus in upper respiratory sample
Measured: 1 year
Secondary outcomes (7)
Symptomatic respiratory infection (student, teacher)
Presence/absence of a cold based on 30 day recall
Measured: 1 year
Symptomatic respiratory infection (household member)
Presence/absence of a cold based on 30 day recall
Measured: 1 year
Viral detection in classroom bioaerosol sample
Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start15 Sep 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Peggy S Lai, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953233
- Sponsor's protocol ID
- IRB-P00045373
- Other IDs
- R21AI178155
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Inner City Air Study
- ClinicalTrials.gov ID
- NCT05953233
- Acronym / sponsor ID
- IRB-P00045373
- Conditions
- Viral Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
| Arm | Type | Receives |
|---|---|---|
| Active HEPA cleaner | Experimental | Other: Active classroom HEPA cleanerActive HEPA cleaners will be placed in classrooms throughout the school year |
| Sham HEPA cleaner | Placebo comparator | Other: Sham classroom HEPA cleanerSham HEPA cleaners will be placed in classrooms throughout the school year |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active classroom HEPA cleanerCommercially available portable HEPA cleaner | Other | Active HEPA cleaner |
| Sham classroom HEPA cleanerCommercially available portable HEPA cleaner with filtration device removed | Other | Sham HEPA cleaner |
Primary outcome
Viral pathogen detected in upper respiratory sample
Time frame: 1 year
Presence/absence of a respiratory virus in upper respiratory sample
7 secondary outcomes
Symptomatic respiratory infection (student, teacher)
Time frame: 1 year
Symptomatic respiratory infection (household member)
Time frame: 1 year
Viral detection in classroom bioaerosol sample
Time frame: 1 year
Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report
Time frame: 1 year
Severity of a cold in adult using the WURSS-24
Time frame: 1 year
Number of missed school or work days in last 30 days
Time frame: 1 year
Number of days requiring inpatient or outpatient care in last 30 days
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active classroom HEPA cleaner in people with Viral Infection, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peggy Lai, MD MPH (617-875-9878, plai@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral pathogen detected in upper respiratory sample (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.