COVID 19NCT04334252
Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia
An observational study of COVID 19, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- Questionnaire
- How many people
- 528 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2020to 20 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- All adult patients > 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital
Who cannot join
- Patients < 18 years
- Adult patients who are unable the give informed consent
- Language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening
Read the 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.
- Conditions
- COVID 19
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of symptoms
Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum
Measured: at the ambulant screening
Prevalence of positive Sars CoV-2 PCR
Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital
Measured: at the ambulant screening
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
Measured: at the ambulant screening
Secondary outcomes (3)
Prediction of symptoms
Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire
Measured: 2 weeks after surgery or treatment
Prediction of symptoms
Prediction of symptoms of COVID 19, based on radiological findings of CT scans
Measured: 2 weeks after surgery or treatment
Prediction of symptoms
Prediction of symptoms of COVID 19, based on COVID 19 PCR results
Measured: 2 weeks after surgery or treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start17 Apr 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ina Callebaut, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334252
- Sponsor's protocol ID
- JessaH_COVID19_prescreening
- Status last verified
- Jan 2021
- First submitted
- 2 Apr 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
- ClinicalTrials.gov ID
- NCT04334252
- Acronym / sponsor ID
- JessaH_COVID19_prescreening
- Conditions
- COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All adult patients > 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital
Key exclusion criteria (3 listed)
- Patients < 18 years
- Adult patients who are unable the give informed consent
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Other | – |
Primary outcome
Prevalence of symptoms
Time frame: at the ambulant screening
Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum
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
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
3 secondary outcomes
Prediction of symptoms
Time frame: 2 weeks after surgery or treatment
Prediction of symptoms
Time frame: 2 weeks after surgery or treatment
Prediction of symptoms
Time frame: 2 weeks after surgery or treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of symptoms (time frame: at the ambulant screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.