Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia

Sponsor
Jessa Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04334252
Collaborator
(none)
528
1
8.1
65.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

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 Design

Study Type:
Observational
Actual Enrollment :
528 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Actual Study Start Date :
Apr 17, 2020
Actual Primary Completion Date :
Dec 20, 2020
Actual Study Completion Date :
Dec 20, 2020

Outcome Measures

Primary Outcome Measures

  1. Prevalence of symptoms [at the ambulant screening]

    Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum

  2. Prevalence of positive Sars CoV-2 PCR [at the ambulant screening]

    Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital

  3. Prevalence of positive radiological findings [at the ambulant screening]

    Prevalence of positive radiological findings in CT scans of the lungs of planned for surgery, treatment or investigation in the hospital

Secondary Outcome Measures

  1. Prediction of symptoms [2 weeks after surgery or treatment]

    Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire

  2. Prediction of symptoms [2 weeks after surgery or treatment]

    Prediction of symptoms of COVID 19, based on radiological findings of CT scans

  3. Prediction of symptoms [2 weeks after surgery or treatment]

    Prediction of symptoms of COVID 19, based on COVID 19 PCR results

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jessa hospital Hasselt Belgium 3500

Sponsors and Collaborators

  • Jessa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ina Callebaut, dr, Jessa Hospital
ClinicalTrials.gov Identifier:
NCT04334252
Other Study ID Numbers:
  • JessaH_COVID19_prescreening
First Posted:
Apr 6, 2020
Last Update Posted:
Jan 6, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2021