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COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection (COLIDE)

Primary Purpose

Diagnoses Disease, Coronavirus

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Novel laser inferometry test for CORONA virus
Sponsored by
Somerset NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnoses Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical suspicion of coronavirus or staff member having a coronavirus test

Exclusion Criteria:

  • unable to give written informed consent

Sites / Locations

  • Somerset NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

primary arm

Arm 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.

Outcomes

Primary Outcome Measures

kappa value
level of agreement between novel test and standard test

Secondary Outcome Measures

sensitivity and specificity
test of accuracy for the result versus a validated sample set

Full Information

First Posted
May 15, 2020
Last Updated
May 22, 2020
Sponsor
Somerset NHS Foundation Trust
Collaborators
University of Exeter, University of Plymouth
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1. Study Identification

Unique Protocol Identification Number
NCT04401644
Brief Title
COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection
Acronym
COLIDE
Official Title
Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somerset NHS Foundation Trust
Collaborators
University of Exeter, University of Plymouth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnoses Disease, Coronavirus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
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.
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
primary arm
Arm Type
Experimental
Arm 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(s)
Novel laser inferometry test for CORONA virus
Intervention Description
detection of virus particles by light absorbtion patterns.
Primary Outcome Measure Information:
Title
kappa value
Description
level of agreement between novel test and standard test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
sensitivity and specificity
Description
test of accuracy for the result versus a validated sample set
Time Frame
unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year
Other Pre-specified Outcome Measures:
Title
clinical utility of test
Description
timeliness of results
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical suspicion of coronavirus or staff member having a coronavirus test Exclusion Criteria: unable to give written informed consent
Facility Information:
Facility Name
Somerset NHS Foundation Trust
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA4 3RF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Tanner
Phone
01823342056
Email
research@tst.nhs.uk
First Name & Middle Initial & Last Name & Degree
Flora Darch
Phone
01823343367
Email
flora.darch@tst.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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.

Learn more about this trial

COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection

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