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

Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19

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

Study Overview

• Status: Unknown
• Conditions: Diagnoses Disease; Coronavirus
• Intervention / Treatment: Diagnostic test: Novel laser inferometry test for CORONA virus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Somerset
    • Taunton, Somerset, United Kingdom, TA4 3RF
      • Somerset NHS Foundation Trust
      • Contact: Karen Tanner; Phone Number: 01823342056; Email: research@tst.nhs.uk
      • Contact: Flora Darch; Phone Number: 01823343367; Email: flora.darch@tst.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unable to give written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: primary arm; 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.	Diagnostic test: Novel laser inferometry test for CORONA virus; detection of virus particles by light absorbtion patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kappa value	level of agreement between novel test and standard test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity and specificity	test of accuracy for the result versus a validated sample set	unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical utility of test	timeliness of results	3 months

Collaborators and Investigators

• Sponsor: Somerset NHS Foundation Trust
• Collaborators: University of Plymouth; University of Exeter

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: RBA20203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No