NCT05648097

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

December 12, 2022

Last Update Submit

December 5, 2023

Conditions

COVID-19

Keywords

Sars-CoV2AerosolsInfection transmissionInfection riskRespiratory Tract InfectionsVirus Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Exposure duration

    Period when exposed to a patient with confirmed COVID-19 in the same room

  • Proportion of immunocompromised patients among those exposed

    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

    At the time of exposure

  • Gender of exposed patients

    At the time of exposure

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients exposed to a patient with COVID-19 isolated at the site - standard of care

Baldachin-Intervention

ACTIVE COMPARATOR

Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin

Device: Baldachin

Interventions

BaldachinDEVICE

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.

Baldachin-Intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

COVID-19Respiratory Tract InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philipp Jent, MD

    Department of Infectious Diseases Inselspital Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Jent, MD

CONTACT

+41 31 632 99 92philipp.jent@insel.ch

Karin J Grimm, MD

CONTACT

+41 31 63 2 76 85KarinJanina.Grimm@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 13, 2022

Study Start

September 13, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)