COVID-19NCT05648097
Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19
A study testing Baldachin in people with COVID-19, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Baldachin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern University Hospital
Bern, Canton of Bern, 3010
Philipp Jent, MD, +41 31 632 99 92, philipp.jent@insel.ch
Karin J Grimm, MD, +41 31 63 2 76 85, KarinJanina.Grimm@insel.ch
About this study
Official title: Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas
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.
Read the detailed description
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".
- Conditions
- COVID-19
- Being tested
- Baldachin
- Keywords
- Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases
- Medical subject headings
- COVID-19, Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Baldachin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 days after last exposure
Secondary outcomes (6)
Exposure duration
Expected to be on average hours up to a few days
Measured: 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
Measured: At the time of exposure
Preexisting air change rate per hour in the rooms where exposure occurs
Measured: At the time of exposure
Age of exposed patients
As part of the demographic characteristics
Measured: At the time of exposure
Gender of exposed patients
As part of the demographic characteristics
Measured: At the time of exposure
Proportion of nosocomially infected patients within 10 days after exposure
As documented in the electronic patient record
Measured: 10 days after last exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start13 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Jent, MD, Principal investigator, Department of Infectious Diseases Inselspital Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648097
- Sponsor's protocol ID
- Balda01
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas
- ClinicalTrials.gov ID
- NCT05648097
- Acronym / sponsor ID
- Balda01
- Conditions
- COVID-19
- Keywords
- Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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".
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients exposed to a patient with COVID-19 isolated at the site - standard of care |
| Baldachin-Intervention | Active comparator | Device: BaldachinPatients exposed to a patient with COVID-19 isolated at the site - under Baldachin |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaldachinEnvironmental 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. | Device | Baldachin-Intervention |
Primary outcome
Proportion of nosocomially infected individuals within 4 days after exposure
Time frame: 4 days after last 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
6 secondary outcomes
Exposure duration
Time frame: Period when exposed to a patient with confirmed COVID-19 in the same room
Proportion of immunocompromised patients among those exposed
Time frame: At the time of exposure
Preexisting air change rate per hour in the rooms where exposure occurs
Time frame: At the time of exposure
Age of exposed patients
Time frame: At the time of exposure
Gender of exposed patients
Time frame: At the time of exposure
Proportion of nosocomially infected patients within 10 days after exposure
Time frame: 10 days after last exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Jent, MD principal investigator
Department of Infectious Diseases Inselspital Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baldachin in people with COVID-19, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Jent, MD (+41 31 632 99 92, philipp.jent@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of nosocomially infected individuals within 4 days after exposure (time frame: 4 days after last exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.