Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04546776 |
| Other study ID # |
QIB05/2020 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2020 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Quadram Institute Bioscience |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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). 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.
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
