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
1 other identifier
interventional
250
1 country
1
Brief Summary
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 26, 2020
May 1, 2020
1.5 years
May 15, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
kappa value
level of agreement between novel test and standard test
6 months
Secondary Outcomes (1)
sensitivity and specificity
unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year
Other Outcomes (1)
clinical utility of test
3 months
Study Arms (1)
primary arm
EXPERIMENTALThere 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.
Interventions
detection of virus particles by light absorbtion patterns.
Eligibility Criteria
You may qualify if:
- clinical suspicion of coronavirus or staff member having a coronavirus test
You may not qualify if:
- unable to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Somerset NHS Foundation Trustlead
- University of Exetercollaborator
- University of Plymouthcollaborator
Study Sites (1)
Somerset NHS Foundation Trust
Taunton, Somerset, TA4 3RF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 26, 2020
Study Start
June 1, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
May 26, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
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.