- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333862
Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy (Covid-19)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bern, Switzerland
- Guido Beldi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare workers of the Department for Visceral Surgery and Medicine
- Patients of the Department for Visceral Surgery and Medicine
- Written informed consent
Exclusion Criteria:
- No informed consent
- Patients with known COVID-19 infection before hospitalization in the investigators' department
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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Hospitalized patients
To compare the infection rate of hospitalized patients versus healthcare workers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fraction of healthcare workers infected with SARS-CoV-2
Time Frame: 90 days
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To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fraction of healthcare workers with COVID-19
Time Frame: 90 days
|
To compare the infection rate of hospitalized patients versus healthcare workers
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90 days
|
Number of patients infected in the hospital
Time Frame: 90 days
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Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.
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90 days
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Development of SARS-CoV2 specific antibody repertoire
Time Frame: 18 months
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To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Guido Beldi, Prof. Dr., Insel Gruppe AG, University Hospital Bern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-00563
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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