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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356560
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Ramon Gordon Jensen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: COVID-19 test, polymerase chain reaction for SARS-CoV-2

Show Show detailed description

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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

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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 Outcome Measures :
  1. 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

  2. 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
oropharyngeal swabs, nasopharyngeal swabs, blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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
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)

Information from the National Library of Medicine

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


Locations
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Denmark
Rigshospitalet University Hospital of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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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
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramon Gordon Jensen, Rigshospitalet, Denmark:
healthcare worker
infection control
otorhinolaryngology
epidemiology
Additional relevant MeSH terms:
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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