COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department
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ClinicalTrials.gov Identifier: NCT04356560 |
Recruitment Status :
Completed
First Posted : April 22, 2020
Last Update Posted : February 1, 2023
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2 |

Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | March 23, 2020 |
Actual Primary Completion Date : | December 30, 2020 |
Actual Study Completion Date : | December 31, 2020 |

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
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Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2
surveillance
Other Name: COVID-19 blood samples, immunoglobuline levels |
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
surveillance
Other Name: COVID-19 blood samples, immunoglobuline levels |
- 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
- 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
- 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)
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 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
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356560
Denmark | |
Rigshospitalet University Hospital of Copenhagen | |
Copenhagen, Denmark, 2100 |
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 |
Responsible Party: | Ramon Gordon Jensen, Principal Investigator, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT04356560 |
Other Study ID Numbers: |
DT P-2020-353 |
First Posted: | April 22, 2020 Key Record Dates |
Last Update Posted: | February 1, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Individual anonymized participant data can be made available on request |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
healthcare worker infection control otorhinolaryngology epidemiology |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |