- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334252
Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia
Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Study Overview
Detailed Description
The exact prevalence of COVID-19 is unknown. Due to the relatively high number of diagnosed, symptomatic infections despite a strict policy, we expect a high prevalence of COVID 19 throughout the entire population. The risk that an asymptomatic carrier who is admitted to the hospital for a (semi)urgent surgery, treatment of investigation transfers the virus to the hospital staff is very high, and vice versa. This risk is even higher during surgery, where intubation is necessary. Therefore we would like to pre-screen all patients ambulantly on the presence of COVID 19 since there is no consensus for screening at the moment. The golden standard is the SARS CoV-2 PCR on the nasopharyngeal sample together with a CT scan of the lungs. Patients in which a bloodsample is taken as standard of care procedure in this ambulant screening will be asked to give more blood for further investigation.
On top of this standard of care screening, we will perform a questionnaire at the pre-operative visit which evaluates the possible occurence of certain symptoms in the last 2 weeks. These symptoms are fever, anorexia, cough, diarrhea, sneezing, vomiting, dyspnea, headache, rhinorrhea, loss of smell, muscle pain, sputum, sore throat and fatigue. Patients were also asked if one of their housemates are affected by these symptoms. Furthermore, 2 weeks after surgery, patient will be contacted to phone in order to fill the same questionnaire.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Hasselt, Belgium, 3500
- Jessa hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients > 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital
Exclusion Criteria:
- Patients < 18 years
- Adult patients who are unable the give informed consent
- Language barrier
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of symptoms
Time Frame: at the ambulant screening
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Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum
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at the ambulant screening
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Prevalence of positive Sars CoV-2 PCR
Time Frame: at the ambulant screening
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Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital
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at the ambulant screening
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Prevalence of positive radiological findings
Time Frame: at the ambulant screening
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Prevalence of positive radiological findings in CT scans of the lungs of planned for surgery, treatment or investigation in the hospital
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at the ambulant screening
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction of symptoms
Time Frame: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire
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2 weeks after surgery or treatment
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Prediction of symptoms
Time Frame: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on radiological findings of CT scans
|
2 weeks after surgery or treatment
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Prediction of symptoms
Time Frame: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on COVID 19 PCR results
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2 weeks after surgery or treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JessaH_COVID19_prescreening
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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