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

March 18, 2023 updated by: Abraar Karan, Stanford University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94403
        • San Mateo Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Covid19
Time Frame: 7th day since enrollment in the trial
Investigators will measure the incidence of Covid19 in susceptible contacts on day 7.
7th day since enrollment in the trial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Yvonne Maldonado, MD, Stanford University
  • Principal Investigator: Abraar Karan, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

March 18, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Filtration Fan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe