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A non-interventional, fully anonymized study for the comparative evaluation of a new direct detection methods for infection with SARS-CoV-2 (COVID-19) in clinical samples

Organizational Data

DRKS-ID:
DRKS00023821
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-11
Last update in DRKS:
2020-12-11
Registration type:
Retrospective

Acronym/abbreviation of the study

LIF-nCov-2019

URL of the study

No Entry

Brief summary in lay language

The overall aim of the current study is the specific detection of SARS-Cov-2 in clinical sample material such as nasopharyngeal swabs, sputum and bronchoalveolar lavage obtained under routine conditions and according to established guidlines using deep UV autofluorescence scanning spectrometer. This methods allows a cost-effective, user friendly, and rapid (< 10 minutes) analysis without chemical consumables. LIF-nCoV-2019 shall allow a rapid diagnosis and cohort isolation and quarantine of SARS-CoV-2 infected individuals. This should facilitate a better control of virus spread and allow a rapid and specific method of virus detection even prior to the establishment of specific PCR or immunoassays also in future pandemics. The envisaged application is for emergency hospitals or test centers and associated with minimal required personal training and no need for laboratory equipment or chemical consumables.

Brief summary in scientific language

The ongoing pandemic of COVID-19 (corona virus disease, 2019) caused by the respiratory infection from the virus SARS-CoV-2 (Severe Acquired Respiratory Syndrome CoronaVirus 2) represents a global public health threat, with millions infected and eventually causing hundreds of thousands of deaths. The ability to detect SARS-CoV-2 with a rapid, highly sensitive and specific method and diagnose infected individuals plays a key role to identify individuals that can transmit the disease to help implement hygiene measures and support medical decision making. Common methods for virus detection such as virus culture or nucleic acid amplification (RT-PCR) are highly specific but time consuming (hours to days) and rapid amplification systems (PCR, isothermal amplification) are restricted due to their high costs. Other methods such as antigen-based diagnostic tests or electron microscopy are lacking sensitivity. Thus, there is an urgent need for robust and rapid, sensitive, specific, user-friendly and cheap detection methods. In studies, deep-UV LIF was successfully applied to differentiate bacteria also in a complex natural environment (Bhartia et al. 2010; Eshelman et al. 2017). Since viruses emit a spectral signature when excited by UV light from the presence of aromatic amino acid in the proteins of the cells (Herzog et al. 1977). The fluorescence cross-section of viruses is 50 to 100-times the cross-section of bacterial cells and spores (YL Pan et al., 2015; Manninen et al. 2014). The fluorescence cross-section of human cells are lower than those of bacteria cells and spores. Recent studies which utilized deep-UV LIF demonstrated the ability to detect single cells and spores in less than 1 s (Bhartia et al. 2010) and proved that bacteria (Hug et al. 2018) and viruses can be differentiated (Babichenko et al. 2018, Gabbarini et al. 2019). Subsequentially, deep-UV LIF was successfully applied to differentiate bacteria also in a complex natural environment (Bhartia et al. 2010; Eshelman et al. 2017). The above studies suggest that spatially resolved deep-UV LIF enables virus identification in nasal swabs at virus concentrations down to 103/ml or less and thus well within the range of the virus load found in patients with SARS-CoV-2.

Health condition or problem studied

ICD10:
J12.8 - Other viral pneumonia
ICD10:
J84.9 - Interstitial pulmonary disease, unspecified
Free text:
COVID-19
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Evaluation of diagnostic method, comparison RT-PCR versus laser-induced fluorescence spectrospcopy for the diagnosis of SARS-CoV-2 infections
Arm 2:
Evaluation of diagnostic method, comparison RT-PCR versus laser-induced fluorescence spectrospcopy for the diagnosis of other respiratory diseases respective in patients without respiratory disease

Endpoints

Primary outcome:
Detection of SARS-CoV-2 genome by reverse transcriptase polymerase chain reaction (RT-PCR) (specific signal and ct value) versus LIF (laser-induced fluorescence spectroscopy, detection of a specific fluorescence emission spectrum) in respiratory specimen from patients with clinical symptoms of a respiratory infection.
Secondary outcome:
-

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

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

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center RWTH Aachen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-04-08
Planned study completion date:
No Entry
Actual Study Completion Date:
2020-04-30
Target Sample Size:
350
Final Sample Size:
356

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
95 Years
Additional Inclusion Criteria:
Patients with respiratory symptoms

Exclusion Criteria

none

Addresses

Primary Sponsor

Address:
Universitätsklinikum der RWTH Aachen
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.ukaachen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Universitätsklinikum der RWTH Aachen
Prof. Dr. med. Mathias Hornef
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+49 241 80-89510
Fax:
+49 241 80-82483
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.ukaachen.de

Contact for Public Queries

Address:
Universitätsklinikum der RWTH Aachen
PD Dr. rer. nat. Michael Kleines
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+49 241 80-88671
Fax:
+49 241 80-82 512
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.ukaachen.de

Principal Investigator

Address:
Universitätsklinikum der RWTH Aachen
Prof. Dr. med. Mathias Hornef
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+49 241 80-89510
Fax:
+49 241 80-82483
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.ukaachen.de

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.)

Address:
Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dfg.de

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Universitätsklinikum der RWTH Aachen
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.ukaachen.de

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum Aachen
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+49-241-8089963
Fax:
+49-241-8082012
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2020-04-01
Ethics committee number:
EK 093/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-04-08

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
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:
Due to the data protection legislation is the propagation of the orginal data not possible. A cooperation data analysis is possible upon reasonable request.

Study protocol and other study documents

Study protocols:
Anfrage Ethikvotum
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

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

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry