Clinical trial NCT04334252: Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia
Official title: Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital and seen at the pre-operative consultation will be asked to participate and to fullfill the questionnaire

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of symptoms
timeFrame: at the ambulant screening
measure: Prevalence of positive Sars CoV-2 PCR
timeFrame: at the ambulant screening
measure: Prevalence of positive radiological findings
timeFrame: at the ambulant screening
Secondary outcomes:
measure: Prediction of symptoms
timeFrame: 2 weeks after surgery or treatment
measure: Prediction of symptoms
timeFrame: 2 weeks after surgery or treatment
measure: Prediction of symptoms
timeFrame: 2 weeks after surgery or treatment
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa hospital
Study officials:
References: