SARS-CoV InfectionCoPSNCT04546776
COVID-19 Persistence in Stool
An observational study of SARS-CoV Infection, run by Quadram Institute Bioscience at 3 sites in United Kingdom.
Trial summary
This is a longitudinal study in which participants that have been confirmed by a National Health Service (NHS) swab test as COVID-19 positive will be asked to provide faecal and saliva samples, and complete short health/lifestyle questionnaires at the time of sampling (referred to as a sample set). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection
- How many people
- 105 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Sep 2020to 9 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who have tested positive for COVID-19, whether isolated at home or admitted to the Norfolk and Norwich University Hospital. Those admitted to the intensive care unit will not be eligible for the study
Who may be able to join
- Men and women aged >18 years
- Those that live or work within a 40-mile radius of Norwich/Norfolk and Norwich University Hospital
- Those who are confirmed COVID-19 positive by an NHS swab test
Who cannot join
- Those who are admitted to an NHS Intensive Care Unit
- Any person related to, or living with, any member of the study team
- Those who are part of the Line Manager/supervisory structure of the Chief Investigators
- Those who are unable to provide written informed consent
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
James Paget University Hospital Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA
Quadram Institute Bioscience
Norwich, Norfolk, NR4 7UQ
Norfolk and Norwich University Hospital Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects
This is a longitudinal study in which participants that have been confirmed by a National Health Service (NHS) swab test as COVID-19 positive will be asked to provide faecal and saliva samples, and complete short health/lifestyle questionnaires at the time of sampling (referred to as a sample set). The number of sample sets collected from any participant will be dependent on how long the SARS-CoV-2 virus persists within the stool. The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and will target all COVID-19-positive subjects, with the exception of those severally ill (e.g. in the intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and up to 200 participants. To obtain the desired numbers, it may be necessary to continue recruitment during any further United Kingdom (UK) COVID-19 infection peaks.
Read the detailed description
Approaching participants will mainly be performed in two ways:
- the Norfolk and Norwich University Hospital (NNUH) online booking system for SARS-CoV-2 testing will have a link to the Quadram Institute Bioscience (QIB) study webpage, which will include the Participant Information Sheet (PIS). When the NHS testing service informs individuals of their test results by text message, the QIB study page Uniform Resource Locator (URL) will be added to the end of the text message for COVID-19 'positive' results. In addition, testing service staff will remind the potential participants of the study if they contact individuals by telephone to inform them of positive COVID-19 results from the test-centre swabs. During this call, potential participants will be asked to provide verbal consent for the study team to contact them for arranging a study talk. Potential participants will be able to contact QIB directly to express interest by email or phone, and can contact QIB to request a hard copy of the PIS be posted to them.
- NNUH staff will approach in-ward patients positive for COVID-19. Should the patients be interested in learning more, a NNUH staff member will provide them with a copy of the PIS and be available to answer any questions the patients may have. Fully informed written consent of hospitalised COVID-19 patients will be performed by an NNUH nurse using the study consent form.
- Participants recruited from a non-hospital setting will be consented, using the same consent form as hospitalised patients, over the telephone/internet video by members of the study team who have received the QIB consent training.
Signed copies of these forms will be collected along with the first sample set. In both scenarios, each point will be explained and all questions will be answered to ensure that the participant is fully informed.
The investigators will also be asking participants whether they would be willing to consent to their samples being stored at the Norwich Research Park Biorepository, and whether they would consent to being re-contacted by researchers about possible future research for which they may be eligible. These are both optional, i.e. should the patient choose not to consent to either or both, they will still be able to participate in the study.
Following the recruitment of COVID-19 positive participants the investigators will ask for an initial faecal and saliva sample, and request that the participant completes a health/lifestyle questionnaire. If participants show symptoms the investigators will collect a second set of samples after 48h of symptoms disappearance (specifically, a lack of fever), whereas if participants are asymptomatic the investigators will collect the second set of samples after 7 days. For both types of participants, the investigators will then collect 2 more sample sets every 7 days (day 7: set 3, day 14: set 4). Should either sample test positive then the investigators will continue the same 7-day sampling process until both samples are negative for two consecutive sample sets, or they have given a total of eight faecal and saliva samples. At either of these points, whichever is earliest, the participant will have then completed the study
- Conditions
- SARS-CoV Infection
- Keywords
- Faeces, Saliva, Whole-genome shotgun sequencing, COVID-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Faecal and saliva sampling | A minimum of 4 and a maximum of 8 sample sets will be asked for over the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and persistence of the SARS-CoV-2 virus in the faeces, and change in associated health status
To verify the prevalence and persistence (starting from symptom onset/diagnosis, and up to seven weeks after recovery) of the SARS-CoV-2 virus in the faeces of people diagnosed with COVID-19 infection.
Measured: Weekly for a maximum of 8 weeks
Secondary outcomes (3)
Viral strain-specific prevalence, associated with change in health status
To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether different viral strains have a different persistence in stool across participants
Measured: Weekly for a maximum of 8 weeks
Biogeographical viral strain identification, associated with change in health status
To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether the viral strain(s) found in the gastrointestinal tract are identical to those found in the respiratory tract of participants
Measured: Weekly for a maximum of 8 weeks
Create a SARS-CoV-2 biological sample repository
To create a repository of material (faeces and saliva) and associated data that will be used to understand the association between gastrointestinal health and SARS-CoV-2 infection in future research.
Measured: Through study completion, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start8 Sep 2020
- Primary completion30 Nov 2024
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 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
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, James Paget University Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Arjan Narbad, BSc, PhD, Principal investigator, Quadram Institute BioscienceNgozi Franslem-Elumogo, MBBS, DTM&H, FRCPath, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)Andreas Brodbeck, PhD, FRCA, FICM, Principal investigator, James Paget University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546776
- Sponsor's protocol ID
- QIB05/2020
- Acronym
- CoPS
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects
- ClinicalTrials.gov ID
- NCT04546776
- Acronym / sponsor ID
- CoPS / QIB05/2020
- Conditions
- SARS-CoV Infection
- Keywords
- Faeces, Saliva, Whole-genome shotgun sequencing, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, James Paget University Hospital NHS Foundation Trust
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 14 Sep 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.
This is a longitudinal study in which participants that have been confirmed by a National Health Service (NHS) swab test as COVID-19 positive will be asked to provide faecal and saliva samples, and complete short health/lifestyle questionnaires at the time of sampling (referred to as a sample set). The number of sample sets collected from any participant will be dependent on how long the SARS-CoV-2 virus persists within the stool. The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and will target all COVID-19-positive subjects, with the exception of those severally ill (e.g. in the intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and up to 200 participants. To obtain the desired numbers, it may be necessary to continue recruitment during any further United Kingdom (UK) COVID-19 infection peaks.
Detailed description
Approaching participants will mainly be performed in two ways:
- the Norfolk and Norwich University Hospital (NNUH) online booking system for SARS-CoV-2 testing will have a link to the Quadram Institute Bioscience (QIB) study webpage, which will include the Participant Information Sheet (PIS). When the NHS testing service informs individuals of their test results by text message, the QIB study page Uniform Resource Locator (URL) will be added to the end of the text message for COVID-19 'positive' results. In addition, testing service staff will remind the potential participants of the study if they contact individuals by telephone to inform them of positive COVID-19 results from the test-centre swabs. During this call, potential participants will be asked to provide verbal consent for the study team to contact them for arranging a study talk. Potential participants will be able to contact QIB directly to express interest by email or phone, and can contact QIB to request a hard copy of the PIS be posted to them.
- NNUH staff will approach in-ward patients positive for COVID-19. Should the patients be interested in learning more, a NNUH staff member will provide them with a copy of the PIS and be available to answer any questions the patients may have. Fully informed written consent of hospitalised COVID-19 patients will be performed by an NNUH nurse using the study consent form.
- Participants recruited from a non-hospital setting will be consented, using the same consent form as hospitalised patients, over the telephone/internet video by members of the study team who have received the QIB consent training.
Signed copies of these forms will be collected along with the first sample set. In both scenarios, each point will be explained and all questions will be answered to ensure that the participant is fully informed.
The investigators will also be asking participants whether they would be willing to consent to their samples being stored at the Norwich Research Park Biorepository, and whether they would consent to being re-contacted by researchers about possible future research for which they may be eligible. These are both optional, i.e. should the patient choose not to consent to either or both, they will still be able to participate in the study.
Following the recruitment of COVID-19 positive participants the investigators will ask for an initial faecal and saliva sample, and request that the participant completes a health/lifestyle questionnaire. If participants show symptoms the investigators will collect a second set of samples after 48h of symptoms disappearance (specifically, a lack of fever), whereas if participants are asymptomatic the investigators will collect the second set of samples after 7 days. For both types of participants, the investigators will then collect 2 more sample sets every 7 days (day 7: set 3, day 14: set 4). Should either sample test positive then the investigators will continue the same 7-day sampling process until both samples are negative for two consecutive sample sets, or they have given a total of eight faecal and saliva samples. At either of these points, whichever is earliest, the participant will have then completed the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faecal and saliva sampling | – | –A minimum of 4 and a maximum of 8 sample sets will be asked for over the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have tested positive for COVID-19, whether isolated at home or admitted to the Norfolk and Norwich University Hospital. Those admitted to the intensive care unit will not be eligible for the study
Key inclusion criteria (3 listed)
- Men and women aged >18 years
- Those that live or work within a 40-mile radius of Norwich/Norfolk and Norwich University Hospital
- Those who are confirmed COVID-19 positive by an NHS swab test
Key exclusion criteria (4 listed)
- Those who are admitted to an NHS Intensive Care Unit
- Any person related to, or living with, any member of the study team
- Those who are part of the Line Manager/supervisory structure of the Chief Investigators
- Those who are unable to provide written informed consent
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
Prevalence and persistence of the SARS-CoV-2 virus in the faeces, and change in associated health status
Time frame: Weekly for a maximum of 8 weeks
To verify the prevalence and persistence (starting from symptom onset/diagnosis, and up to seven weeks after recovery) of the SARS-CoV-2 virus in the faeces of people diagnosed with COVID-19 infection.
3 secondary outcomes
Viral strain-specific prevalence, associated with change in health status
Time frame: Weekly for a maximum of 8 weeks
Biogeographical viral strain identification, associated with change in health status
Time frame: Weekly for a maximum of 8 weeks
Create a SARS-CoV-2 biological sample repository
Time frame: Through study completion, up to two 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 17 Jun 2025.
- 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.
Arjan Narbad, BSc, PhD principal investigator
Quadram Institute Bioscience
Ngozi Franslem-Elumogo, MBBS, DTM&H, FRCPath principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Andreas Brodbeck, PhD, FRCA, FICM principal investigator
James Paget University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by Quadram Institute Bioscience at 3 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 3 inclusion and 4 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Prevalence and persistence of the SARS-CoV-2 virus in the faeces, and change in associated health status (time frame: Weekly for a maximum of 8 weeks). 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 17 Jun 2025.