COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection

NCT ID: NCT04401644

Last Updated: 2020-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diagnoses Disease Coronavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Novel laser inferometry test for CORONA virus

Intervention Type DIAGNOSTIC_TEST

detection of virus particles by light absorbtion patterns.

Interventions

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Novel laser inferometry test for CORONA virus

detection of virus particles by light absorbtion patterns.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unable to give written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

University of Plymouth

OTHER

Sponsor Role collaborator

Somerset NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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Karen Tanner

Role: primary

01823342056

Flora Darch

Role: backup

01823343367

Other Identifiers

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RBA20203

Identifier Type: -

Identifier Source: org_study_id

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