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Clinical Trials/NCT04356560
NCT04356560CompletedNot Applicable

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

Rigshospitalet, Denmark1 site in 1 country100 target enrollmentStarted: March 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Incidence of ENT patients with SARS-CoV-2

Study Overview

Brief 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. 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

  • SARS CoV-2 and bacterial super infections in upper respiratory airways(6 months)
  • Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ramon Gordon Jensen

Principal Investigator

Rigshospitalet, Denmark

Study Sites (1)

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