Coronavirus InfectionSTOPCOVID19NCT04359849
Sequencing and Tracking of Phylogeny in COVID-19 Study
An observational study of Coronavirus Infection, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The Investigators plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Coronavirus Infection
- How many people
- 5,602 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2020to 30 Sep 2022
- 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 7 years and older
- All sexes
- Child, Adult, Older adult
Study population: Focus on those whose tests have provided a positive result so as to maximise the number of SARS-CoV-2 genomes generated.
Who may be able to join
- Have undergone successful testing for Covid-19
- Have sufficient viral RNA remaining for research analysis following testing for Covid-19
Who cannot join
- Insufficient viral RNA remains following testing for Covid-19
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
The Investigators plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus
Read the detailed description
The current Covid-19 pandemic has caused significant strain on the health care system, and an unprecedented Governmental response to stem the spread of the disease through social distancing and self-isolation. Covid-19 is a pneumonia-like severe acute respiratory syndrome (SARS) caused by a virus, SARS-CoV-2, with similarity to the SARS virus responsible for a worldwide outbreak in 2002. Due to the original SARS outbreak, a large body of genomic data exists for SARS coronaviruses, allowing researchers to understand how the new virus SARS-CoV-2 has evolved to be so virulent in humans.
Whilst testing kits have been designed to target specific genes in the viral RNA, whole genome sequencing of the virus offers increased scope to track the epidemiology of the virus. In addition, through the use of current sequencing technology available from Oxford Nanopore Technologies (ONT), genome scanning can be performed in real time and allow for identification of specific viral variants within patient samples. As the pandemic continues to spread, understanding the evolution of the virus and its spread across the globe will help researchers to begin to predict the future spread of the virus, estimate the number of worldwide cases, and aid in the development of epidemiological models for estimating a potential end point to the pandemic crisis. In addition, the ability to track mutations in real time allows researchers access to a large body of data to explore in order to identify potential targets for cures and vaccines. These data will also feed into the design of RNA-based therapeutic targets and diagnostics using patented array technology.
In this project, the investigators aim to use Nanopore-based sequencing technology to assemble viral genomes from patients who have presented to Portsmouth Hospital NHS Trust (PHT) in the Wessex region with symptoms of Covid-19. PHT, has containment level 3 (CL3) facilities within their Microbiology Department required for inactivation of the virus and extraction of viral RNA, and has recently begun testing of potential Covid-19 patients. Viral RNA samples from patients who show positive results will be selected for sequencing using Nanopore sequencing technology. Whole genome sequences will be compared using phylogenetic analysis to identify the spread of the virus within the local area, will be analysed in the context of anonymised patient level data to look for trends in the adaptation of the virus, and will be compared with a global database of such sequences to help develop global maps of transmission.
As part of the COVID-19 Genomics UK Consortium (COG-UK), the investigators will contribute sequencing data to the consortium which will monitor changes in the virus on a national scale to understand how the virus is mutating and spreading and whether different strains are emerging
- Conditions
- Coronavirus Infection
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of whole genome sequences for the SARS-CoV-2 virus from viral RNA samples
Generated using Nanopore-based whole genome sequencing techniques
Measured: 2 years
Secondary outcomes (1)
Transmission rates of the SARS-CoV-2 virus
Identify mutations and viral strains prevalent within the Wessex region
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start4 May 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- Retrospective
- Enrolment
- 5,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359849
- Sponsor's protocol ID
- PHT/2020/34
- Acronym
- STOPCOVID19
- Status last verified
- Jan 2023
- First submitted
- 20 Apr 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequencing and Tracking of Phylogeny in COVID-19 Study
- ClinicalTrials.gov ID
- NCT04359849
- Acronym / sponsor ID
- STOPCOVID19 / PHT/2020/34
- Conditions
- Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,602 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Apr 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 Investigators plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus
Detailed description
The current Covid-19 pandemic has caused significant strain on the health care system, and an unprecedented Governmental response to stem the spread of the disease through social distancing and self-isolation. Covid-19 is a pneumonia-like severe acute respiratory syndrome (SARS) caused by a virus, SARS-CoV-2, with similarity to the SARS virus responsible for a worldwide outbreak in 2002. Due to the original SARS outbreak, a large body of genomic data exists for SARS coronaviruses, allowing researchers to understand how the new virus SARS-CoV-2 has evolved to be so virulent in humans.
Whilst testing kits have been designed to target specific genes in the viral RNA, whole genome sequencing of the virus offers increased scope to track the epidemiology of the virus. In addition, through the use of current sequencing technology available from Oxford Nanopore Technologies (ONT), genome scanning can be performed in real time and allow for identification of specific viral variants within patient samples. As the pandemic continues to spread, understanding the evolution of the virus and its spread across the globe will help researchers to begin to predict the future spread of the virus, estimate the number of worldwide cases, and aid in the development of epidemiological models for estimating a potential end point to the pandemic crisis. In addition, the ability to track mutations in real time allows researchers access to a large body of data to explore in order to identify potential targets for cures and vaccines. These data will also feed into the design of RNA-based therapeutic targets and diagnostics using patented array technology.
In this project, the investigators aim to use Nanopore-based sequencing technology to assemble viral genomes from patients who have presented to Portsmouth Hospital NHS Trust (PHT) in the Wessex region with symptoms of Covid-19. PHT, has containment level 3 (CL3) facilities within their Microbiology Department required for inactivation of the virus and extraction of viral RNA, and has recently begun testing of potential Covid-19 patients. Viral RNA samples from patients who show positive results will be selected for sequencing using Nanopore sequencing technology. Whole genome sequences will be compared using phylogenetic analysis to identify the spread of the virus within the local area, will be analysed in the context of anonymised patient level data to look for trends in the adaptation of the virus, and will be compared with a global database of such sequences to help develop global maps of transmission.
As part of the COVID-19 Genomics UK Consortium (COG-UK), the investigators will contribute sequencing data to the consortium which will monitor changes in the virus on a national scale to understand how the virus is mutating and spreading and whether different strains are emerging
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Focus on those whose tests have provided a positive result so as to maximise the number of SARS-CoV-2 genomes generated.
Key inclusion criteria (2 listed)
- Have undergone successful testing for Covid-19
- Have sufficient viral RNA remaining for research analysis following testing for Covid-19
Key exclusion criteria (1 listed)
- Insufficient viral RNA remains following testing for Covid-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of whole genome sequences for the SARS-CoV-2 virus from viral RNA samples
Time frame: 2 years
Generated using Nanopore-based whole genome sequencing techniques
1 secondary outcome
Transmission rates of the SARS-CoV-2 virus
Time frame: 2 years
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 3 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Portsmouth Hospitals NHS Trust at 1 site 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 2 inclusion and 1 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of whole genome sequences for the SARS-CoV-2 virus from viral RNA samples (time frame: 2 years). 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 3 Apr 2023.