COVID-19NCT04356560
COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department
An observational study of COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 test, polymerase chain reaction for SARS-CoV-2
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Mar 2020to 31 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Danish healthcare workers. variation in socioeconomic background. Majority lives in Greater Copenhagen area 2. Danish patients all ages, variation in socioeconomic background. Patients with cancers tends to be older, higher prevalence of comorbidities. Live in eastern region of Denmark. Patients with upper airway complications to infections tend to be younger and without comorbidities. Majority from Greater Copenhagen area
Who may be able to join
- Healthcare workers of all professions with daily routines at the Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen
- All patients with symptoms of upper respiratory tract infections
- All patients undergoing surgery involving the mucosa of the upper airways
Who cannot join
- healthcare workers not affiliated to the department
- Patients without symptoms of upper respiratory tract infection (e.g otitis externa, fractures)
- Patients undergoing surgery not involving the upper airway (e.g thyroidectomy, Neck)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet University Hospital of Copenhagen
Copenhagen, 2100
About this study
Official title: SARS-CoV-2 Surveillance of Patients and Healthcare Workers at the Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark
Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. With a concurrent lack of personal protection, it is of paramount importance to identify patients and healthcare workers at an early stage to prevent a COVID-19 outbreak in the department. A baseline study of all healthcare workers has been performed. Follow-up will be accomplished by interval testing, antibody measurements and REDcap Covid-19 questionnaires. All patients at risk of carrying SARS-CoV-2, or who are candidates for high-risk airway surgery will be tested. Infection control measures at the department will be implemented progressively according to the real-time surveillance results from both patients and healthcare workers.
Read the detailed description
At present the COVID-19 pandemic is evolving, and numbers of cases admitted to hospital and case fatalities are on the rise in Denmark.
The epidemic of SARS-CoV-2 can pose a great burden on all healthcare systems at both national and local level.Data from the SARS epidemic (2002-2003) showed that the countries with the largest number of cases were China (including administrative regions), Canada and Singapore.Healthcare workers accounted for 20%,43% and 41%, respectively of the total number of cases.
In the initial stages of the current pandemic, Wuhan ear-nose and throat (ENT) doctors were affected at higher rates than other doctors at the hospital (personal message from Stanford University, confirmed in media). This has been acknowledged by the Confederation of European Otorhinolaryngology - Head and Neck Surgery (CEORL HNS). A possible explanation is the close contact with the patient's airway mucosa during routine ENT examinations, the risk of inducing sneezing and coughing during these examinations and the use of nasal endoscopic procedures among other airway procedures,at both examination and during surgery. Compared to SARS, the new SARS-CoV-2 seems to have a higher viral load in the nasopharynx, posing increased risk for ENT doctors.
Persons who experience symptoms from the airways are in Denmark advised to stay at home, as they may have COVID-19, and only contact the health care system if the situation deteriorates. However, unspecific symptoms or complications in the upper airways, the oral cavity, pharynx and neck can lead to contact with an ENT department, e.g. in case of symptoms potentially related to cancer. Bacterial super infections as complications to viral airway infections is seen during e.g. influenza epidemics. Acute bacterial middle ear infections is one of the most common infections among children and is associated with virus in 80 % of cases. Complications include acute mastoiditis, ethmoiditis and peritonsillar abscess,which are potentially life-threatening conditions which need to be treated at a hospital ENT department. It is not known if the incidence of these bacterial super infections will increase during the SARS-CoV-2 pandemic or if such an increase will lead to a concurrent increase in the exposure of virus to the healthcare workers within the ENT departments.
COVID-19 has a broad spectrum of clinical presentations from asymptomatic, to complicated pneumonias, to multi-organ failure and death. Studies have shown that 2/3 of patients with SARS-CoV-2 will have debut of symptoms from the upper airways.
Protecting and monitoring healthcare workers and patients The mode of human transmission for SARS-Cov-2 is not fully understood, but expected to be through direct contact and partly by aerosol transmission, which is the reason for the health authorities' current advice of keeping distance.
SARS-Cov-2 can remain viable as aerosols for more than three hours, with a half-life of 1.1 hours and on plastic surfaces for up to 72 hours with a half-life of 6.8 hours.
Virus has shown to be present in the oropharynx the first week after symptom onset with a subsequent decline, but viral RNA has been detected up to 25 days after.
The use of personal protection including mask and gloves are essential for healthcare workers treating patients with COVID-19.
However, on March 3rd 2020 The World Health Organization announced global shortage of personal protection supplies. In Denmark, there is also a current shortage of adequate protection, which increases the risk for healthcare workers as the epidemic intensifies in the population.
Large scale population testing in Iceland indicates that half of individuals carrying SARS-CoV-2 are asymptomatic. With a concurrent lack of personal protection in a department with a high risk of SARS-CoV-2 exposure, it is important to identify infected patients and infected healthcare workers at an early stage,in order to prevent a COVID-19 outbreak within the department.
As the Danish healthcare system was not prepared for an epidemic of this nature, detailed guidelines to reduce transmission to healthcare workers at department level are deficient. The department will progressively implement infection disease control measures based on monitored real time data from the patient and healthcare worker surveillance. Control measures will follow local guidelines and be inspired by recommendations from departments who managed the SARS epidemic.
- Conditions
- COVID-19
- Being tested
- COVID-19 test, polymerase chain reaction for SARS-CoV-2
- Keywords
- healthcare worker, infection control, otorhinolaryngology, epidemiology
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 test, polymerase chain reaction for SARS-CoV-2Diagnostic test
Also called COVID-19 blood samples, immunoglobuline levels
surveillance
| Study group | Role | What they receive |
|---|---|---|
| healthcare workers | Actively working at Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark. During 2020 COVID 19 pandemic Receives: Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2 | |
| Patients | Patients presenting with complications to upper respiratory tract infections and patients undergoing surgery involving airway mucosa During 2020 COVID 19 pandemic Receives: Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of healthcare workers with SARS-CoV-2
Change from baseline in number of healthcare workers positive for SARS-CoV-2. Measured by repetitive naso/oropharyngeal swab tests of all active healthcare workers at the department.
Measured: 6 months
Incidence of ENT patients with SARS-CoV-2
Change from baseline in number of patients positive for SARS-CoV-2. Measured by naso/oropharyngeal swab tests
Measured: 6 months
Development of SARS-CoV-2 antibodies among healthcare workers
Incidence and prevalence of SARS-CoV-2 antibodies by repetitive blood samples testing SARS-CoV-2 antibody levels of immunoglobulin G and immunoglobulin M
Measured: 6 months
Secondary outcomes (2)
Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers
Compare number of positive questionnaires with number of positive oro/nasopharyngeal swab test and antibody tests
Measured: 6 months
SARS CoV-2 and bacterial super infections in upper respiratory airways
Change from baseline in total number of complications to upper respiratory tract infections (URTI). Proportion of SARS CoV-2 positives among patients with URTI compared to proportion of SARS CoV-2 positive among ENT patients with non-infectious disease (eg cancer)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start23 Mar 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
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 Copenhagen University Hospital, RigshospitaletThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Gordon Jensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Inge J Knudsen, MD, Study chair, Rigshospitalet, Department of MicrobiologyNikolai S Kirkeby, MSc, Study chair, Rigshospitalet, Department of MicrobiologyRamon G Jensen, MD, Principal investigator, Rigshospitalet, Dep. of ORL, Head and neck & Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356560
- Sponsor's protocol ID
- DT P-2020-353
- Status last verified
- Jan 2023
- First submitted
- 13 Apr 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual anonymized participant data can be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Surveillance of Patients and Healthcare Workers at the Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark
- ClinicalTrials.gov ID
- NCT04356560
- Acronym / sponsor ID
- DT P-2020-353
- Conditions
- COVID-19
- Keywords
- healthcare worker, infection control, otorhinolaryngology, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 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.
Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. With a concurrent lack of personal protection, it is of paramount importance to identify patients and healthcare workers at an early stage to prevent a COVID-19 outbreak in the department. A baseline study of all healthcare workers has been performed. Follow-up will be accomplished by interval testing, antibody measurements and REDcap Covid-19 questionnaires. All patients at risk of carrying SARS-CoV-2, or who are candidates for high-risk airway surgery will be tested. Infection control measures at the department will be implemented progressively according to the real-time surveillance results from both patients and healthcare workers.
Detailed description
At present the COVID-19 pandemic is evolving, and numbers of cases admitted to hospital and case fatalities are on the rise in Denmark.
The epidemic of SARS-CoV-2 can pose a great burden on all healthcare systems at both national and local level.Data from the SARS epidemic (2002-2003) showed that the countries with the largest number of cases were China (including administrative regions), Canada and Singapore.Healthcare workers accounted for 20%,43% and 41%, respectively of the total number of cases.
In the initial stages of the current pandemic, Wuhan ear-nose and throat (ENT) doctors were affected at higher rates than other doctors at the hospital (personal message from Stanford University, confirmed in media). This has been acknowledged by the Confederation of European Otorhinolaryngology - Head and Neck Surgery (CEORL HNS). A possible explanation is the close contact with the patient's airway mucosa during routine ENT examinations, the risk of inducing sneezing and coughing during these examinations and the use of nasal endoscopic procedures among other airway procedures,at both examination and during surgery. Compared to SARS, the new SARS-CoV-2 seems to have a higher viral load in the nasopharynx, posing increased risk for ENT doctors.
Persons who experience symptoms from the airways are in Denmark advised to stay at home, as they may have COVID-19, and only contact the health care system if the situation deteriorates. However, unspecific symptoms or complications in the upper airways, the oral cavity, pharynx and neck can lead to contact with an ENT department, e.g. in case of symptoms potentially related to cancer. Bacterial super infections as complications to viral airway infections is seen during e.g. influenza epidemics. Acute bacterial middle ear infections is one of the most common infections among children and is associated with virus in 80 % of cases. Complications include acute mastoiditis, ethmoiditis and peritonsillar abscess,which are potentially life-threatening conditions which need to be treated at a hospital ENT department. It is not known if the incidence of these bacterial super infections will increase during the SARS-CoV-2 pandemic or if such an increase will lead to a concurrent increase in the exposure of virus to the healthcare workers within the ENT departments.
COVID-19 has a broad spectrum of clinical presentations from asymptomatic, to complicated pneumonias, to multi-organ failure and death. Studies have shown that 2/3 of patients with SARS-CoV-2 will have debut of symptoms from the upper airways.
Protecting and monitoring healthcare workers and patients The mode of human transmission for SARS-Cov-2 is not fully understood, but expected to be through direct contact and partly by aerosol transmission, which is the reason for the health authorities' current advice of keeping distance.
SARS-Cov-2 can remain viable as aerosols for more than three hours, with a half-life of 1.1 hours and on plastic surfaces for up to 72 hours with a half-life of 6.8 hours.
Virus has shown to be present in the oropharynx the first week after symptom onset with a subsequent decline, but viral RNA has been detected up to 25 days after.
The use of personal protection including mask and gloves are essential for healthcare workers treating patients with COVID-19.
However, on March 3rd 2020 The World Health Organization announced global shortage of personal protection supplies. In Denmark, there is also a current shortage of adequate protection, which increases the risk for healthcare workers as the epidemic intensifies in the population.
Large scale population testing in Iceland indicates that half of individuals carrying SARS-CoV-2 are asymptomatic. With a concurrent lack of personal protection in a department with a high risk of SARS-CoV-2 exposure, it is important to identify infected patients and infected healthcare workers at an early stage,in order to prevent a COVID-19 outbreak within the department.
As the Danish healthcare system was not prepared for an epidemic of this nature, detailed guidelines to reduce transmission to healthcare workers at department level are deficient. The department will progressively implement infection disease control measures based on monitored real time data from the patient and healthcare worker surveillance. Control measures will follow local guidelines and be inspired by recommendations from departments who managed the SARS epidemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthcare workers | – | Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2Actively working at Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark. During 2020 COVID 19 pandemic |
| Patients | – | Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2Patients presenting with complications to upper respiratory tract infections and patients undergoing surgery involving airway mucosa During 2020 COVID 19 pandemic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Danish healthcare workers. variation in socioeconomic background. Majority lives in Greater Copenhagen area 2. Danish patients all ages, variation in socioeconomic background. Patients with cancers tends to be older, higher prevalence of comorbidities. Live in eastern region of Denmark. Patients with upper airway complications to infections tend to be younger and without comorbidities. Majority from Greater Copenhagen area
Key inclusion criteria (3 listed)
- Healthcare workers of all professions with daily routines at the Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen
- All patients with symptoms of upper respiratory tract infections
- All patients undergoing surgery involving the mucosa of the upper airways
Key exclusion criteria (3 listed)
- healthcare workers not affiliated to the department
- Patients without symptoms of upper respiratory tract infection (e.g otitis externa, fractures)
- Patients undergoing surgery not involving the upper airway (e.g thyroidectomy, Neck)
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 |
|---|---|---|
| COVID-19 test, polymerase chain reaction for SARS-CoV-2Also: COVID-19 blood samples, immunoglobuline levelssurveillance | Diagnostic test | Patients, healthcare workers |
Primary outcome
Incidence of healthcare workers with SARS-CoV-2
Time frame: 6 months
Change from baseline in number of healthcare workers positive for SARS-CoV-2. Measured by repetitive naso/oropharyngeal swab tests of all active healthcare workers at the department.
Incidence of ENT patients with SARS-CoV-2
Time frame: 6 months
Change from baseline in number of patients positive for SARS-CoV-2. Measured by naso/oropharyngeal swab tests
Development of SARS-CoV-2 antibodies among healthcare workers
Time frame: 6 months
Incidence and prevalence of SARS-CoV-2 antibodies by repetitive blood samples testing SARS-CoV-2 antibody levels of immunoglobulin G and immunoglobulin M
2 secondary outcomes
Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers
Time frame: 6 months
SARS CoV-2 and bacterial super infections in upper respiratory airways
Time frame: 6 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 1 Feb 2023.
- Individual participant dataSharing planned: Undecided. Individual anonymized participant data can be made available on request
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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.
Inge J Knudsen, MD study chair
Rigshospitalet, Department of Microbiology
Nikolai S Kirkeby, MSc study chair
Rigshospitalet, Department of Microbiology
Ramon G Jensen, MD principal investigator
Rigshospitalet, Dep. of ORL, Head and neck & Audiology
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 COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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 1 Feb 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 Denmark. 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?
Incidence of healthcare workers with SARS-CoV-2 (time frame: 6 months). The study lists 3 primary outcomes in all. 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 1 Feb 2023.