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ExploreCOVID – identification of optimal CT imaging biomarkers in combination with clinical markers and RT-PCR for diagnosis of COVID-19

Organizational Data

DRKS-ID:
DRKS00023913
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-21
Last update in DRKS:
2022-06-17
Registration type:
Prospective

Acronym/abbreviation of the study

ExploreCOVID

URL of the study

No Entry

Brief summary in lay language

SARS-CoV-2 infection is currently diagnosed using a special molecular biological technique, the so-called polymerase chain reaction (PCR). In order to be able to assess the severity and development of pneumonia in COVID-19 disease, computed tomography (CT) of the lungs is traditionally performed. However, the PCR does not give an exact indication of the stage of the disease. Previous findings allow the conclusion that there are mutual relationships between the stage of the disease and the appearance on CT. As part of the study, a procedure for the exact and uniform assessment of COVID-19 diseases is being developed in order to find risk factors. For this purpose, the radiological findings and the clinical course between COVID-19 patients and patients with suspected pneumonia of another cause or patients without lung disease are compared. Artificial intelligence (AI) is also used in the study as an aid to assess the proposed catalog of criteria.

Brief summary in scientific language

Currently, the diagnosis of SARS-CoV-2 infection is usually made with a real-time polymerase chain reaction (RT-PCR). The extent and dynamics of pneumonia in COVID-19 is classically assessed using computed tomography (CT) of the thorax. While the RT-PCR method detects the virus, it does not provide quantitative data on the stage of the disease. Findings so far allow the conclusion that there are correlations between the stage of the disease and the radiological appearance. As part of the study, a procedure for the quantitative and standardised assessment and documentation of COVID-19 diseases is being developed in order to identify risk factors. For this purpose, the radiological findings and the clinical course will be compared between COVID-19 patients and patients with suspicion of pneumonias of other causes or patients without lung disease. Artificial intelligence (AI) is also used in the study as an aid to assess a proposed catalogue of criteria.

Health condition or problem studied

Free text:
COVID-19
ICD10:
U07.1 - COVID-19, virus identified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Assessment of the existing chest CT and collection of clinical data in the course -Patients with confirmed COVID-19 infection (PCR test positive)
Arm 2:
- Patients with suspected COVID-19 associated respiratory syndrome with negative PCR testing
Arm 3:
- Healthy patients without symptoms
Arm 4:
Patients with pneumonia without suspicion of COVID-19

Endpoints

Primary outcome:
1. Detection of imaging biomarkers for data-based diagnosis and treatment of COVID-19 patients
Secondary outcome:
2. Correlation of radiological findings with RT-PCR, clinical biomarkers and the course of the COVID-19 disease 3. Development of a clinical guideline and definition of clinically relevant imaging biomarkers for diagnosis, risk stratification and treatment response of COVID-19 patients 4. Development of an evidence-based guideline for the stratification and use of high-risk patients with the provision of an open access database.

Study Design

Purpose:
Prognosis
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Gastroenterologie, Infektionen, Vergiftungen Im Neuenheimer Feld 410, 69120 Heidelberg Heidelberg
  • University medical center Klinik für Diagnostische und Interventionelle Radiologie Im Neuenheimer Feld 110, 69120 Heidelberg Heidelberg
  • University medical center Diagnostische und Interventionelle Radiologie mit Nuklearmedizin Thoraxklinik, Röntgenstr.1, 69126 Heidelberg Heidelberg

Recruitment period and number of participants

Planned study start date:
2020-12-22
Actual study start date:
2020-12-22
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-06-30
Target Sample Size:
1000
Final Sample Size:
158

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Study population: • Patients with confirmed COVID-19 infection • Patients with suspected COVID-19 associated respiratory syndrome with negative PCR testing • Existing CT images of the chest • Age ≥ 18 years Control cohort: Healthy patients without symptoms and patients with lung diseases without suspicion of COVID-19

Exclusion Criteria

Age < 18 years

Addresses

Primary Sponsor

Universitätsklinikum Heidelberg
Im Neuenheimer Feld 672
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Pascal Probst
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
06221-5636209
Fax:
06221-5633850
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.1010.0.html

Contact for Public Queries

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Pascal Probst
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
06221-5636209
Fax:
06221-5633850
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.1010.0.html

Principal Investigator

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Pascal Probst
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
06221-5636209
Fax:
06221-5633850
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Chirurgische-Klinik.1010.0.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-11-02
Ethics committee number:
S-813/2020
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-11-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1262-7515
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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