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Completed

NCT Number: NCT04334252

Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa hospital

Hasselt, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire

Primary outcomes

  1. Prevalence of symptoms

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Prediction of symptoms

    Time frame: 2 weeks after surgery or treatment

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

  2. Prediction of symptoms

    Time frame: 2 weeks after surgery or treatment

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

  3. Prediction of symptoms

    Time frame: 2 weeks after surgery or treatment

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

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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