Trial document





This trial has been registered retrospectively.
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  DRKS00023821

Trial Description

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Title

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

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Trial Acronym

LIF-nCov-2019

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URL of the Trial

[---]*

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description 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.

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Organizational Data

  •   DRKS00023821
  •   2020/12/11
  •   [---]*
  •   yes
  •   Approved
  •   EK 093/20, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J12.8 -  Other viral pneumonia
  •   J84.9 -  Interstitial pulmonary disease, unspecified
  •   COVID-19
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Interventions/Observational Groups

  •   Evaluation of diagnostic method, comparison RT-PCR versus laser-induced fluorescence spectrospcopy for the diagnosis of SARS-CoV-2 infections
  •   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
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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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.

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Secondary Outcome

-

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/08
  •   350
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   95   Years
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Additional Inclusion Criteria

Patients with respiratory symptoms

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • RWTH Aachen, Lehrstuhl für Ingenieurgeologie und Hydrogeologie
    • Mr.  Prof. Dr.  Florian  Amann 
    • Lochnerstraße 4-20
    • 52056  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Prof. Dr. med.   Mathias  Hornef 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  PD Dr. rer. nat.   Michael  Kleines 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/30
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Trial Publications, Results and other Documents

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