Covid19NCT04531501
COVID-19 Saliva Test Research Study
An observational study of Covid19, run by Chronomics Limited at 2 sites in United Kingdom.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 117 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Saliva and NPS test
- How many people
- 400 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Jun 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 117 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study is being conducted at specific hospitals so will apply geographically to people within the eligibility criteria as described above.
Who may be able to join
None listed.
Who cannot join
- Site 2: Positive Matching approach Inclusion Criteria 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.
- Exclusion Criteria Individuals who have not tested at all or have not tested positive.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gloucestershire Royal Hospital
Gloucester
Salford Royal NHS Foundation Trust
Salford
About this study
Official title: COVID-19 Saliva Test Research Study - Evaluation of High Throughput COVID-19 Testing Via Saliva Based Sampling and Alternative RNA Extraction Methods.
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?
Read the detailed description
In December 2019, a novel coronavirus caused an outbreak in Wuhan, China. Just a month later, Covid-19 was declared a Public Health Emergency of International Concern on 30 January 2020. The World Health Organisation (WHO) repeatedly announced that 'Diagnostic testing for COVID-19 is critical to tracking the virus, understanding epidemiology, informing case management, and to suppressing transmission'. The priority within Public Health England (PHE) was to scale up public health testing using molecular diagnosis through real-time RT-PCR (RdRp gene) assay based on oral swabs.
Some of the key challenges publicly presented regarding testing are speed of mobilisation, supply chain issues due to the international demand for crucial testing materials like kits, swabs and chemical reagents, and the quality and comfort of the nasopharyngeal (NSP) swabs commonly used.
Chronomics has developed novel methods to address these problems. Firstly, due to the shortage of the specific branded reagent products used in the official CDC FDA EUA COVID-19 RT-qPCR protocol for RNA extraction, Chronomics have sourced and compiled testing of components to create an extraction kit with greater availability of supply for use within the protocol. Secondly, Chronomics' methods are based on saliva collection which are pain-free and easy to collect.
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? There are two components of Chronomics' testing framework that the investigators are looking to validate to feed into this. Firstly, that Chronomics' alternative reagents and workflow (RNA-extraction and RT-PCR steps) do not impact sensitivity of detection and secondly, that Chronomics' alternative sampling source of saliva also does not impact sensitivity of detection. To achieve validation of these two components, the investigators will compare both a Chronomics saliva sample vs an NHS NPS sample, and a Chronomics NPS sample vs an NHS NPS sample. The investigators would require access to the output (and information as to the linked patient) for the NHS gold-standard workflow.
- Conditions
- Covid19
- Being tested
- Saliva and NPS test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Saliva and NPS test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Result
Positive / Negative / Indeterminate
Measured: Within 2 weeks of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronomics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531501
- Sponsor's protocol ID
- 283560
- Status last verified
- Jul 2022
- First submitted
- 26 Aug 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Saliva Test Research Study - Evaluation of High Throughput COVID-19 Testing Via Saliva Based Sampling and Alternative RNA Extraction Methods.
- ClinicalTrials.gov ID
- NCT04531501
- Acronym / sponsor ID
- 283560
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Chronomics LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
In December 2019, a novel coronavirus caused an outbreak in Wuhan, China. Just a month later, Covid-19 was declared a Public Health Emergency of International Concern on 30 January 2020. The World Health Organisation (WHO) repeatedly announced that 'Diagnostic testing for COVID-19 is critical to tracking the virus, understanding epidemiology, informing case management, and to suppressing transmission'. The priority within Public Health England (PHE) was to scale up public health testing using molecular diagnosis through real-time RT-PCR (RdRp gene) assay based on oral swabs.
Some of the key challenges publicly presented regarding testing are speed of mobilisation, supply chain issues due to the international demand for crucial testing materials like kits, swabs and chemical reagents, and the quality and comfort of the nasopharyngeal (NSP) swabs commonly used.
Chronomics has developed novel methods to address these problems. Firstly, due to the shortage of the specific branded reagent products used in the official CDC FDA EUA COVID-19 RT-qPCR protocol for RNA extraction, Chronomics have sourced and compiled testing of components to create an extraction kit with greater availability of supply for use within the protocol. Secondly, Chronomics' methods are based on saliva collection which are pain-free and easy to collect.
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? There are two components of Chronomics' testing framework that the investigators are looking to validate to feed into this. Firstly, that Chronomics' alternative reagents and workflow (RNA-extraction and RT-PCR steps) do not impact sensitivity of detection and secondly, that Chronomics' alternative sampling source of saliva also does not impact sensitivity of detection. To achieve validation of these two components, the investigators will compare both a Chronomics saliva sample vs an NHS NPS sample, and a Chronomics NPS sample vs an NHS NPS sample. The investigators would require access to the output (and information as to the linked patient) for the NHS gold-standard workflow.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suspected to have Covid-19 | – | Diagnostic Test: Saliva and NPS testIndividuals 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. |
| Patients tested positive for Covid-19 | – | Diagnostic Test: Saliva and NPS testIndividuals 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. |
Who may qualify
- Ages
- 18 to 117 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study is being conducted at specific hospitals so will apply geographically to people within the eligibility criteria as described above.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Site 2: Positive Matching approach Inclusion Criteria 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.
- Exclusion Criteria Individuals who have not tested at all or have not tested positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva and NPS testN/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 | Diagnostic test | Patients suspected to have Covid-19, Patients tested positive for Covid-19 |
Primary outcome
Test Result
Time frame: Within 2 weeks of sample collection
Positive / Negative / Indeterminate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Chronomics Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Result (time frame: Within 2 weeks of sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.