Official Title
Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects
Brief Summary

This is a longitudinal study in which participants that have been confirmed by a NationalHealth Service (NHS) swab test as COVID-19 positive will be asked to provide faecal andsaliva samples, and complete short health/lifestyle questionnaires at the time ofsampling (referred to as a sample set). The number of sample sets collected from anyparticipant 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 willtarget all COVID-19-positive subjects, with the exception of those severally ill (e.g. inthe intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and upto 200 participants. To obtain the desired numbers, it may be necessary to continuerecruitment during any further United Kingdom (UK) COVID-19 infection peaks.

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

Active, not recruiting
SARS-CoV Infection
Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

James Paget University Hospital Foundation Trust
Great Yarmouth, Norfolk, United Kingdom

Quadram Institute Bioscience
Norwich, Norfolk, United Kingdom

Norfolk and Norwich University Hospital Foundation Trust
Norwich, Norfolk, United Kingdom

Quadram Institute Bioscience
NCT Number
Keywords
Faeces
Saliva
Whole-genome shotgun sequencing
Covid-19
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome