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Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections (SCout)

17. september 2021 opdateret af: Ulf Teichgräber, Jena University Hospital

Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To prevent spreading of the new coronavirus (SARS-CoV-2) from patients who are infected but in whom infection was not detected by means of Reverse transcription polymerase chain reaction (RT-PCR) and who are to be admitted to ordinary wards of hospitals, we aimed to determine validity of exclusion of pneumonia immediately before admission by means of chest computed tomography.

Patients admitted to the emergency department of the university hospital Jena with Covid-19 symptoms (temperature > 37.5°C; respiratory and/or gastrointestinal symptoms) whose RT-PCR test resulted negative, undergo a chest CT scan. Those patients without pulmonary infiltrates can be safely ruled out for Covid-19. Thus, CT has perfect selectivity evidence regarding pulmonary infiltrates; it has limited selectivity concerning the pathogenesis of the infiltration.

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

The hypothesis is that chest CT has the greatest clinical evidence (no detection of lung infiltration) when the RT-PCT is tested negative. We assume that chest CT has a high sensitivity for diagnosis of respiratory dominant COVID-19. A pulmonary COVID-19 in epidemic areas can be best ruled out when chest CT is negative for the presence of infiltrations of the lung parenchyma. This is described by the SNOUT principle which is an acronym for 'Sensitive test when Negative rules OUT the disease' under the condition of a low pretest probability.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

145

Kontakter og lokationer

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Studiesteder

  • Tyskland
    • Thuringia
      • Jena, Thuringia, Tyskland, 07747
        • Jena University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with unspecific symptoms of SARS-CoV-2 infection who are to be admitted to hospital for any disease and who provide written informed consent to undergo rt-PCR, chest CT, and antibody test.

Beskrivelse

Inclusion Criteria:

  • ≥ 18 years
  • Provided written informed consent
  • Intended hospital admission for any reason
  • Symptoms that suggest infection with SARS-CoV-2
  • Participant agrees to rt PCR and antibody test (SARS-CoV-2)

Exclusion Criteria:

  • < 18 years
  • Pregnancy cannot be excluded

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
Tidsramme: At hospital admission
Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)
At hospital admission

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and specificity of chest CT in patients with pulmonary comorbidities
Tidsramme: At hospital admission
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with pulmonary comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
At hospital admission
Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities
Tidsramme: At hospital admission
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with cardiovascular comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
At hospital admission
Sensitivity and specificity of chest CT in patients with malignancy
Tidsramme: At hospital admission
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with malignancy who are to be admitted to hospital and who are rt-PCR negative for infection with SARS-CoV-2.
At hospital admission
Sensitivity and specificity of chest CT in patients with immunodeficiency
Tidsramme: At hospital admission
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with immunodeficiency who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
At hospital admission

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictive value of specific chest CT findings for detection of SARS-CoV-2
Tidsramme: At hospital admission
Predictive value of chest CT
At hospital admission

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jena University Hospital

Efterforskere

  • Ledende efterforsker: Ulf Teichgräber, Prof. Dr., Department of Radiology, Jena University Hospital, Germany

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2020

Primær færdiggørelse (Faktiske)

20. maj 2020

Studieafslutning (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først indsendt

20. april 2020

Først indsendt, der opfyldte QC-kriterier

21. april 2020

Først opslået (Faktiske)

22. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IDIR-001-2020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is not a plan to make IPD available.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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