<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04401644</url>
  </required_header>
  <id_info>
    <org_study_id>RBA20203</org_study_id>
    <nct_id>NCT04401644</nct_id>
  </id_info>
  <brief_title>COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection</brief_title>
  <acronym>COLIDE</acronym>
  <official_title>Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Somerset NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Plymouth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Somerset NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab&#xD;
      samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will develop novel primers to detect single virus particles in patient&#xD;
      samples. The method involves the absorption of light by single virus particles giving a&#xD;
      specific pattern. The investigators will develop the device to create a microdroplet of&#xD;
      carrier fluid that is run through the trial device. The investigators will develop novel&#xD;
      binding receptors for preferential capture of Coronavirus.&#xD;
&#xD;
      The investigators will review the results of the novel test against the standard diagnostic&#xD;
      test and identify virus particles in test negative subjects.&#xD;
&#xD;
      The investigators will isolate the viral rna in test negative subjects and perform sequencing&#xD;
      to find novel mutations that are not detected by the current test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The participants and the primary care provider will be masked to the outcome of the test. The test will not be used to determine clinical care and the result of the original diagnostic test will be masked from the outcomes assessor of the novel test under investigation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>kappa value</measure>
    <time_frame>6 months</time_frame>
    <description>level of agreement between novel test and standard test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity</measure>
    <time_frame>unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year</time_frame>
    <description>test of accuracy for the result versus a validated sample set</description>
  </secondary_outcome>
  <other_outcome>
    <measure>clinical utility of test</measure>
    <time_frame>3 months</time_frame>
    <description>timeliness of results</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Diagnoses Disease</condition>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>primary arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will only be one set of participants with each participants samples and results as the comparator groups. There will be within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Novel laser inferometry test for CORONA virus</intervention_name>
    <description>detection of virus particles by light absorbtion patterns.</description>
    <arm_group_label>primary arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical suspicion of coronavirus or staff member having a coronavirus test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to give written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Somerset NHS Foundation Trust</name>
      <address>
        <city>Taunton</city>
        <state>Somerset</state>
        <zip>TA4 3RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Karen Tanner</last_name>
      <phone>01823342056</phone>
      <email>research@tst.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Flora Darch</last_name>
      <phone>01823343367</phone>
      <email>flora.darch@tst.nhs.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>During the trial, the investigators will store a list of participants and their unique trial number on a password protected file and computer in the Clinical Research Department. After the trial has completed, and when the data is stored or used, any information that could identify an individual participant will be removed or &quot;pseudonymised&quot;. A pseudonym is a unique identifier which does not reveal the participant's 'real world' identity.&#xD;
Personal identifiable data will not be shared with any other outside organisation. The results of the tests will be shared with the collaborators using a unique trial number. Any remaining blood sample material will be frozen and stored as serum using the unique trial number in Musgrove Park Hospital's research laboratory.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401644
org study id: RBA20203
nct id: NCT04401644
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab
      samples.
The investigators will develop novel primers to detect single virus particles in patient
      samples. The method involves the absorption of light by single virus particles giving a
      specific pattern. The investigators will develop the device to create a microdroplet of
      carrier fluid that is run through the trial device. The investigators will develop novel
      binding receptors for preferential capture of Coronavirus.

      The investigators will review the results of the novel test against the standard diagnostic
      test and identify virus particles in test negative subjects.

      The investigators will isolate the viral rna in test negative subjects and perform sequencing
      to find novel mutations that are not detected by the current test.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: The participants and the primary care provider will be masked to the outcome of the test. The test will not be used to determine clinical care and the result of the original diagnostic test will be masked from the outcomes assessor of the novel test under investigation.
measure: kappa value
time frame: 6 months
description: level of agreement between novel test and standard test
measure: sensitivity and specificity
time frame: unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year
description: test of accuracy for the result versus a validated sample set
measure: clinical utility of test
time frame: 3 months
description: timeliness of results
arm group label: primary arm
arm group type: Experimental
description: There will only be one set of participants with each participants samples and results as the comparator groups. There will be within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
intervention type: Diagnostic Test
intervention name: Novel laser inferometry test for CORONA virus
description: detection of virus particles by light absorbtion patterns.
arm group label: primary arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronavirus Infections
sharing ipd: No
ipd description: During the trial, the investigators will store a list of participants and their unique trial number on a password protected file and computer in the Clinical Research Department. After the trial has completed, and when the data is stored or used, any information that could identify an individual participant will be removed or "pseudonymised". A pseudonym is a unique identifier which does not reveal the participant's 'real world' identity.
Personal identifiable data will not be shared with any other outside organisation. The results of the tests will be shared with the collaborators using a unique trial number. Any remaining blood sample material will be frozen and stored as serum using the unique trial number in Musgrove Park Hospital's research laboratory.