Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05777720

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

100

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators are evaluating whether an intervention consisting of box-fans with MERV 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of Covid19 from an index case to susceptible contacts within the home.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: Filtration Fan Behavioral: Safe-home pamphlet Behavioral: Mid-week phone call	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Cluster-randomized Controlled Trial of Air Filtration and Ventilation Improvements to Reduce SARS CoV 2 Transmission Among Household Contacts

Actual Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control No intervention will be administered in this arm. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will provide a link to the basic CDC isolation guidelines which would be part of standard of care. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.
Experimental: Intervention Families are provided with one filtration fan unit per room in their home (and one for the index case; if the family lives in a studio, they would receive 2 units). Investigators will advise families on ventilation improvements in their home. Investigators will provide an instructional pamphlet that describes how the fans work and the importance of ventilation. Investigators will follow-up on day 3-4 to check in and run through a checklist to ensure the fans are working and ventilation improvements are being attempted. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.	Device: Filtration Fan Investigators are using box fans with attached MERV16 filters, a design that has been tested and published in the scientific literature. Behavioral: Safe-home pamphlet The pamphlet has information on how the filtration fans work through visual images; and images of ventilation improvements in the home through opening windows. Behavioral: Mid-week phone call On day 3-4 of the study, the study coordinator assigned to the house will call and check in regarding the filtration fan usage and remind families about the importance of filtration and ventilation.

Arm

Intervention/Treatment

No Intervention: Control

No intervention will be administered in this arm. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will provide a link to the basic CDC isolation guidelines which would be part of standard of care. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.

Experimental: Intervention

Families are provided with one filtration fan unit per room in their home (and one for the index case; if the family lives in a studio, they would receive 2 units). Investigators will advise families on ventilation improvements in their home. Investigators will provide an instructional pamphlet that describes how the fans work and the importance of ventilation. Investigators will follow-up on day 3-4 to check in and run through a checklist to ensure the fans are working and ventilation improvements are being attempted. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.

Device: Filtration Fan

Investigators are using box fans with attached MERV16 filters, a design that has been tested and published in the scientific literature.

Behavioral: Safe-home pamphlet

The pamphlet has information on how the filtration fans work through visual images; and images of ventilation improvements in the home through opening windows.

Behavioral: Mid-week phone call

On day 3-4 of the study, the study coordinator assigned to the house will call and check in regarding the filtration fan usage and remind families about the importance of filtration and ventilation.

Outcome Measures

Primary Outcome Measures

Incidence of Covid19 [7th day since enrollment in the trial]
Investigators will measure the incidence of Covid19 in susceptible contacts on day 7.

Secondary Outcome Measures

Incidence of new upper respiratory symptoms [7th day since enrollment in the trial]
Investigators will measure reported new upper respiratory symptoms in susceptible contacts.
Average CO2 levels [7 days]
Investigators will measure 7 day average CO2 levels in the home (measured in parts per million)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Household members live in a shared space (apartment, home) with others (as opposed to renting single rooms in a shared space, for example)
At least 3 other people live in the household aside from index case

Exclusion Criteria:

If index case test positive day was over 2 days prior
If half or more household members are thought to be infected already
If household has fewer than 3 contacts interested in participating in the study
If fewer than 3 contacts are expected to be present in the house for a majority of the following 7 days