- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04334252
Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia
Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Hasselt, Belgia, 3500
- Jessa Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Prevalence of symptoms
Tidsramme: at the ambulant screening
|
Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum
|
at the ambulant screening
|
Prevalence of positive Sars CoV-2 PCR
Tidsramme: at the ambulant screening
|
Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital
|
at the ambulant screening
|
Prevalence of positive radiological findings
Tidsramme: 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
|
at the ambulant screening
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Prediction of symptoms
Tidsramme: 2 weeks after surgery or treatment
|
Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire
|
2 weeks after surgery or treatment
|
Prediction of symptoms
Tidsramme: 2 weeks after surgery or treatment
|
Prediction of symptoms of COVID 19, based on radiological findings of CT scans
|
2 weeks after surgery or treatment
|
Prediction of symptoms
Tidsramme: 2 weeks after surgery or treatment
|
Prediction of symptoms of COVID 19, based on COVID 19 PCR results
|
2 weeks after surgery or treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JessaH_COVID19_prescreening
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på COVID-19
-
Yang I. PachankisAktiv, ikke rekrutterendeCOVID-19 luftveisinfeksjon | COVID-19 stresssyndrom | Covid-19-vaksinebivirkning | COVID-19-assosiert tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-assosiert hjerneslagKina
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbeidspartnereFullførtPostakutte følgetilstander av COVID-19 | Tilstand etter covid-19 | Langvarig COVID | Kronisk COVID-19 syndromItalia
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRekrutteringCovid-19-pandemi | Covid-19-vaksiner | COVID-19 virussykdomIndonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkHar ikke rekruttert ennåPost-COVID-19 syndrom | Lang COVID | Lang Covid19 | Tilstand etter covid-19 | Post-COVID syndrom | Tilstand etter COVID-19, uspesifisert | Tilstand etter COVIDNederland
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyFullførtPost-COVID-19 syndrom | Long-COVID-19 syndromTyskland
-
Indonesia UniversityRekrutteringPost-COVID-19 syndrom | Lang COVID | Tilstand etter covid-19 | Post-COVID syndrom | Lang COVID-19Indonesia
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRekrutteringCOVID-19 lungebetennelse | COVID-19 luftveisinfeksjon | Covid-19-pandemi | COVID-19 akutt respiratorisk distress-syndrom | COVID-19-assosiert lungebetennelse | COVID 19 assosiert koagulopati | COVID-19 (Coronavirus Disease 2019) | COVID-19-assosiert tromboembolismeHellas
-
Endourage, LLCRekrutteringLang COVID | Lang Covid19 | Post-akutt COVID-19 | Langdistanse COVID | Langdistanse COVID-19 | Postakutt covid-19 syndromForente stater
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital og andre samarbeidspartnereRekrutteringKohortoppfølging av epidemi og nevroimaging for pasienter under den første bølgen av COVID-19 i KinaCovid-19 | Post-COVID-19 syndrom | Post-akutt COVID-19 | Akutt COVID-19Kina