Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19

Study Overview
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Brief Summary
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In this study, a patient space occupied by a patient with confirmed COVID-19 in an open-space multiple bed area in the Intermediate Care Unit will be equipped with a mobile, optimally placed high efficiency particulate air (HEPA)-equivalent air filtration unit (Baldachin) in addition to existing hospital policy infection prevention and control measures. The investigators are going to evaluate this intervention regarding its capacity to prevent the nosocomial onwards transmission of Sars-COV2 to patients located in the same multiple-bed open space patient area.

Detailed Description
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SARS-CoV-2 transmission includes a considerable amount of long-distance aerosol transmission. Ideal isolation is in single rooms. Isolation in special care multiple bed open-space patient areas (e.g. in the Intensive and Intermediate Care Unit) is set back to onsite isolation with distancing and ventilation as partial mitigation measures against nosocomial transmission. The investigators want to assess the effect of supplementation of existing room ventilation by means of an optimally placed mobile high efficiency particulate air (HEPA) filtration unit (Baldachin) in the ceiling area over confirmed COVID-19 infected patients on nosocomial onwards transmission to patients located in the same open-space multiple bed area. In order to quantify the effect, the investigators will determine the proportion of nosocomially infected individuals as assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit rooms with Baldachin vs. open-space Intermediate Care Unit rooms without Baldachin.

Official Title
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Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas

Conditions
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COVID-19

Intervention / Treatment
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* Device: Baldachin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult inpatients of included open-space IMC units with lab-confirmed SARS-CoV-2 infection, symptom onset or date of test ≤10 days prior inclusion. Exclusion Criteria: Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patients exposed to a patient with COVID-19 isolated at the site - standard of care | |
| Active Comparator: Baldachin-Intervention<br>Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin | Device: Baldachin<br>* Environmental intervention: Equipment of a patient space of a patient with confirmed COVID-19 in open-space multiple bed Intermediate Care Unit areas with a mobile, optimally placed high efficiency particulate air (HEPA)-equivalent air filtration unit (Baldachin) in addition to existing room ventilation and hospital policy infection prevention and control measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of nosocomially infected individuals within 4 days after exposure | Assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit (IMC) rooms with the environmental interventions vs. open-space IMC rooms without the environmental intervention | 4 days after last exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure duration | Expected to be on average hours up to a few days | Period when exposed to a patient with confirmed COVID-19 in the same room | 
| Proportion of immunocompromised patients among those exposed | e.g. patients under treatment with steroids, chemotherapy | At the time of exposure | 
| Preexisting air change rate per hour in the rooms where exposure occurs |  | At the time of exposure | 
| Age of exposed patients | As part of the demographic characteristics | At the time of exposure | 
| Gender of exposed patients | As part of the demographic characteristics | At the time of exposure | 
| Proportion of nosocomially infected patients within 10 days after exposure | As documented in the electronic patient record | 10 days after last exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases