COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department

NCT04356560 | Completed DMC

• 1 other identifier: DT P-2020-353
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

healthcare worker; infection control; otorhinolaryngology; epidemiology

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  6 months

Secondary Outcomes (2)

• Sensitivity and specificity of a COVID-19 screening symptom questionnaire among healthcare workers

  6 months

• SARS CoV-2 and bacterial super infections in upper respiratory airways

  6 months

Study Arms (2)

healthcare workers

Actively working at Department of Otorhinolaryngology Head and Neck Surgery \& Audiology, Rigshospitalet University Hospital of Copenhagen, Denmark. During 2020 COVID 19 pandemic

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

Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2

Interventions

COVID-19 test, polymerase chain reaction for SARS-CoV-2 DIAGNOSTIC_TEST

surveillance

Also known as: COVID-19 blood samples, immunoglobuline levels

Patients; healthcare workers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

oropharyngeal swabs, nasopharyngeal swabs, blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Inge J Knudsen, MD

  Rigshospitalet, Department of Microbiology

  STUDY CHAIR

• Nikolai S Kirkeby, MSc

  Rigshospitalet, Department of Microbiology

  STUDY CHAIR

• Ramon G Jensen, MD

  Rigshospitalet, Dep. of ORL, Head and neck & Audiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 22, 2020
• Study Start: March 23, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

DK (1)