Clinical trial NCT04356560: COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: healthcare worker
infection control
otorhinolaryngology
epidemiology
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Healthcare workers of all professions with daily routines at the Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen
2. All patients with symptoms of upper respiratory tract infections
3. All patients undergoing surgery involving the mucosa of the upper airways

Exclusion Criteria:

1. healthcare workers not affiliated to the department
2. Patients without symptoms of upper respiratory tract infection (e.g otitis externa, fractures)
3. Patients undergoing surgery not involving the upper airway (e.g thyroidectomy, Neck)

Primary outcomes:
measure: Incidence of healthcare workers with SARS-CoV-2
timeFrame: 6 months
measure: Incidence of ENT patients with SARS-CoV-2
timeFrame: 6 months
measure: Development of SARS-CoV-2 antibodies among healthcare workers
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers
timeFrame: 6 months
measure: SARS CoV-2 and bacterial super infections in upper respiratory airways
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital of Copenhagen
Study officials:
affiliation: Rigshospitalet, Department of Microbiology
name: Inge J Knudsen, MD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Department of Microbiology
name: Nikolai S Kirkeby, MSc
role: STUDY_CHAIR
affiliation: Rigshospitalet, Dep. of ORL, Head and neck & Audiology
name: Ramon G Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: