SARS-CoV-2Covid-19NCT04333862
Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy
An observational study of SARS-CoV-2, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- How many people
- 519 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Mar 2020to 31 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care workers and patients of the Department for Visceral Surgery and Medicine
Who may be able to join
- Healthcare workers of the Department for Visceral Surgery and Medicine
- Patients of the Department for Visceral Surgery and Medicine
- Written informed consent
Who cannot join
- No informed consent
- Patients with known COVID-19 infection before hospitalization in the investigators' department
Trial locations and contacts
1 site in 1 country.
About this study
Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided.
The main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and causes a pandemic of coronavirus disease 2019 (COVID-19, the disease caused by SARS-CoV-2). Protecting and supporting caregivers is essential to maintain the workforce in the hospital to treat patients.
The use of recommended barrier precautions such as masks, gloves and gowns is of highest priority in the care of all patients with respiratory symptoms. However, given the long incubation period of 5 days there will be undiagnosed but infected patients with clinically mild cases, atypical presentations or even no symptoms at all. Thus, healthcare workers are on the one side at risk to get infected by asymptomatic patients and on the other side are critically needed for later phases of the epidemic, when the resources will in all likelihood be scarce or depleted.
One potential strategy to maintain workforce throughout an epidemic is to reduce the workforce in the early phases. Reducing workforce at early phases might potentially reduce in-hospital infection of the caregivers and reduces early burnout. One way of reducing the active workforce is to postpone all elective and non-urgent medical interventions to later phases of the epidemic.
Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. This new regulation took effect on March 16th 2020.
Currently available resources to perform tests for SARS-CoV-2 infection are limited for the clinical routine and are therefore not available for research purposes. Thus, in the context of a clinical study the investigators aim to perform additional testing of SARS-CoV-2 of healthcare workers and patients in order to determine the clinical consequences of such desynchronization strategy, firstly within the current epidemic and secondly for future outbreaks.
The main aim of present study is to determine if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers providing healthcare | To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy | |
| Healthcare workers staying at home | To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy | |
| Hospitalized patients | To compare the infection rate of hospitalized patients versus healthcare workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of healthcare workers infected with SARS-CoV-2
To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy
Measured: 90 days
Secondary outcomes (3)
Fraction of healthcare workers with COVID-19
To compare the infection rate of hospitalized patients versus healthcare workers
Measured: 90 days
Number of patients infected in the hospital
Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.
Measured: 90 days
Development of SARS-CoV2 specific antibody repertoire
To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start19 Mar 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Prof. Dr., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333862
- Sponsor's protocol ID
- 2020-00563
- Acronym
- Covid-19
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2020
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy
- ClinicalTrials.gov ID
- NCT04333862
- Acronym / sponsor ID
- Covid-19 / 2020-00563
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Apr 2020 (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.
Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided.
The main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and causes a pandemic of coronavirus disease 2019 (COVID-19, the disease caused by SARS-CoV-2). Protecting and supporting caregivers is essential to maintain the workforce in the hospital to treat patients.
The use of recommended barrier precautions such as masks, gloves and gowns is of highest priority in the care of all patients with respiratory symptoms. However, given the long incubation period of 5 days there will be undiagnosed but infected patients with clinically mild cases, atypical presentations or even no symptoms at all. Thus, healthcare workers are on the one side at risk to get infected by asymptomatic patients and on the other side are critically needed for later phases of the epidemic, when the resources will in all likelihood be scarce or depleted.
One potential strategy to maintain workforce throughout an epidemic is to reduce the workforce in the early phases. Reducing workforce at early phases might potentially reduce in-hospital infection of the caregivers and reduces early burnout. One way of reducing the active workforce is to postpone all elective and non-urgent medical interventions to later phases of the epidemic.
Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. This new regulation took effect on March 16th 2020.
Currently available resources to perform tests for SARS-CoV-2 infection are limited for the clinical routine and are therefore not available for research purposes. Thus, in the context of a clinical study the investigators aim to perform additional testing of SARS-CoV-2 of healthcare workers and patients in order to determine the clinical consequences of such desynchronization strategy, firstly within the current epidemic and secondly for future outbreaks.
The main aim of present study is to determine if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers providing healthcare | – | –To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy |
| Healthcare workers staying at home | – | –To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy |
| Hospitalized patients | – | –To compare the infection rate of hospitalized patients versus healthcare workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers and patients of the Department for Visceral Surgery and Medicine
Key inclusion criteria (3 listed)
- Healthcare workers of the Department for Visceral Surgery and Medicine
- Patients of the Department for Visceral Surgery and Medicine
- Written informed consent
Key exclusion criteria (2 listed)
- No informed consent
- Patients with known COVID-19 infection before hospitalization in the investigators' department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fraction of healthcare workers infected with SARS-CoV-2
Time frame: 90 days
To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy
3 secondary outcomes
Fraction of healthcare workers with COVID-19
Time frame: 90 days
Number of patients infected in the hospital
Time frame: 90 days
Development of SARS-CoV2 specific antibody repertoire
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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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.
Guido Beldi, Prof. Dr. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of healthcare workers infected with SARS-CoV-2 (time frame: 90 days). 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 13 Nov 2024.