We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Persistence in Stool (CoPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546776
Recruitment Status : Active, not recruiting
First Posted : September 14, 2020
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
Norfolk and Norwich University Hospitals NHS Foundation Trust
James Paget University Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Quadram Institute Bioscience

Brief 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). 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.

Condition or disease
SARS-CoV Infection

Detailed Description:

Approaching participants will mainly be performed in two ways:

  1. 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.
  2. 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023


Group/Cohort
Faecal and saliva sampling
A minimum of 4 and a maximum of 8 sample sets will be asked for over the study period



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Viral strain-specific prevalence, associated with change in health status [ Time Frame: Weekly for a maximum of 8 weeks ]
    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

  2. Biogeographical viral strain identification, associated with change in health status [ Time Frame: Weekly for a maximum of 8 weeks ]
    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

  3. Create a SARS-CoV-2 biological sample repository [ Time Frame: Through study completion, up to two years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546776


Locations
Layout table for location information
United Kingdom
James Paget University Hospital Foundation Trust
Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
Quadram Institute Bioscience
Norwich, Norfolk, United Kingdom, NR4 7UQ
Norfolk and Norwich University Hospital Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Quadram Institute Bioscience
Norfolk and Norwich University Hospitals NHS Foundation Trust
James Paget University Hospital NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Arjan Narbad, BSc, PhD Quadram Institute Bioscience
Principal Investigator: Ngozi Franslem-Elumogo, MBBS, DTM&H, FRCPath Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Principal Investigator: Andreas Brodbeck, PhD, FRCA, FICM James Paget University Hospital
Layout table for additonal information
Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT04546776    
Other Study ID Numbers: QIB05/2020
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quadram Institute Bioscience:
Faeces
Saliva
Whole-genome shotgun sequencing
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases