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

Primary Purpose

Covid19

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Filtration Fan
Safe-home pamphlet
Mid-week phone call
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring ventilation, air filtration, Covid19, SARS CoV 2, household transmission

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Mateo Medical Center
  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Covid19
Investigators will measure the incidence of Covid19 in susceptible contacts on day 7.

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2023
Last Updated
March 18, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05777720
Brief Title
Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes
Official Title
A Cluster-randomized Controlled Trial of Air Filtration and Ventilation Improvements to Reduce SARS CoV 2 Transmission Among Household Contacts
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
ventilation, air filtration, Covid19, SARS CoV 2, household transmission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Filtration Fan
Intervention Description
Investigators are using box fans with attached MERV16 filters, a design that has been tested and published in the scientific literature.
Intervention Type
Behavioral
Intervention Name(s)
Safe-home pamphlet
Intervention Description
The pamphlet has information on how the filtration fans work through visual images; and images of ventilation improvements in the home through opening windows.
Intervention Type
Behavioral
Intervention Name(s)
Mid-week phone call
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Covid19
Description
Investigators will measure the incidence of Covid19 in susceptible contacts on day 7.
Time Frame
7th day since enrollment in the trial
Secondary Outcome Measure Information:
Title
Incidence of new upper respiratory symptoms
Description
Investigators will measure reported new upper respiratory symptoms in susceptible contacts.
Time Frame
7th day since enrollment in the trial
Title
Average CO2 levels
Description
Investigators will measure 7 day average CO2 levels in the home (measured in parts per million)
Time Frame
7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Maldonado, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abraar Karan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Mateo Medical Center
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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