Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia

COVID 19 Clinical Trial

Official title:

Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334252
• Other study ID #: JessaH_COVID19_prescreening
• Status: Completed
• Start date: April 17, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19

Intervention

Other:
• Questionnaire
Questionnaire

Locations

Country	Name	City	State
Belgium	Jessa hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of symptoms	Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum	at the ambulant screening
Primary	Prevalence of positive Sars CoV-2 PCR	Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital	at the ambulant screening
Primary	Prevalence of positive radiological findings	Prevalence of positive radiological findings in CT scans of the lungs of planned for surgery, treatment or investigation in the hospital	at the ambulant screening
Secondary	Prediction of symptoms	Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire	2 weeks after surgery or treatment
Secondary	Prediction of symptoms	Prediction of symptoms of COVID 19, based on radiological findings of CT scans	2 weeks after surgery or treatment
Secondary	Prediction of symptoms	Prediction of symptoms of COVID 19, based on COVID 19 PCR results	2 weeks after surgery or treatment