- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356560
COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Rigshospitalet University Hospital of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Danish healthcare workers. variation in socioeconomic background. Majority lives in Greater Copenhagen area
- 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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
healthcare workers
Actively working at Department of Otorhinolaryngology Head and Neck Surgery & Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark.
During 2020 COVID 19 pandemic
|
surveillance
Other Names:
|
Patients
Patients presenting with complications to upper respiratory tract infections and patients undergoing surgery involving airway mucosa During 2020 COVID 19 pandemic
|
surveillance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers
Time Frame: 6 months
|
Compare number of positive questionnaires with number of positive oro/nasopharyngeal swab test and antibody tests
|
6 months
|
SARS CoV-2 and bacterial super infections in upper respiratory airways
Time Frame: 6 months
|
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)
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Inge J Knudsen, MD, Rigshospitalet, Department of Microbiology
- Study Chair: Nikolai S Kirkeby, MSc, Rigshospitalet, Department of Microbiology
- Principal Investigator: Ramon G Jensen, MD, Rigshospitalet, Dep. of ORL, Head and neck & Audiology
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT P-2020-353
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on COVID-19 test, polymerase chain reaction for SARS-CoV-2
-
University Hospital, ToursNot yet recruitingCertain Disorders Involving the Immune MechanismFrance
-
Polish Society of Disaster MedicineActive, not recruiting
-
University of ThessalyCompleted
-
Medical University of GrazLagos State University; Walter Sisulu University; Management Sciences for Health and other collaboratorsEnrolling by invitationCovid19 | Hiv | ARTNigeria, South Africa
-
Centro Medico ABCTerminated
-
University of VirginiaCompletedPneumonia | SARS-CoV 2 | Corona Virus Infection | SARS PneumoniaUnited States
-
University Hospital, Basel, SwitzerlandWithdrawn
-
Noah MerinJohns Hopkins UniversityTerminatedCovid-19 | Sars-CoV2United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingChronic Lymphocytic Leukemia | COVID-19 InfectionUnited States
-
Hannover Medical SchoolElse Kröner Fresenius FoundationRecruitingCOVID-19 | Respiratory Infections in Children | Maternal Vaccine ExposureGermany