NCT04531501

Brief Summary

The objective of this study is to compare the Chronomics test against the NPS tests and protocol currently in use to demonstrate the efficacy of Chronomics' approach. The principal question is: Does the Chronomics saliva based test perform as well as the NPS NHS test?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

June 29, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

August 26, 2020

Last Update Submit

July 26, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Test Result

    Positive / Negative / Indeterminate

    Within 2 weeks of sample collection

Study Arms (2)

Patients suspected to have Covid-19

Individuals suspected to have COVID-19 who are admitted to Gloucestershire Hospitals NHS Foundation Trust facilities for treatment for COVID-19. Individuals with full mental capacity.

Diagnostic Test: Saliva and NPS test

Patients tested positive for Covid-19

Individuals tested positive for COVID-19 at Northern Care Alliance NHS Group using an NHS NPS test who are accessible within 24 hours and consent to providing a saliva sample and further NPS sample for Chronomics.

Diagnostic Test: Saliva and NPS test

Interventions

Saliva and NPS testDIAGNOSTIC_TEST

N/A Our study will not impact their path of care as they will be doing an NHS test which will determine their path of care at the NHS

Patients suspected to have Covid-19Patients tested positive for Covid-19

Eligibility Criteria

Age18 Years - 117 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study is being conducted at specific hospitals so will apply geographically to people within the eligibility criteria as described above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 28, 2020

Study Start

June 29, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)