COVID-19 Persistence in Stool

NCT04546776 | Completed

• 1 other identifier: QIB05/2020
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 3

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.

Conditions

SARS-CoV Infection

Keywords

Faeces; Saliva; Whole-genome shotgun sequencing; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  Weekly for a maximum of 8 weeks

Secondary Outcomes (3)

• Viral strain-specific prevalence, associated with change in health status

  Weekly for a maximum of 8 weeks

• Biogeographical viral strain identification, associated with change in health status

  Weekly for a maximum of 8 weeks

• Create a SARS-CoV-2 biological sample repository

  Through study completion, up to two years

Study Arms (1)

Faecal and saliva sampling

A minimum of 4 and a maximum of 8 sample sets will be asked for over the study period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• James Paget University Hospital NHS Foundation Trust: collaborator

Study Sites (3)

James Paget University Hospital Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

Location

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Norfolk and Norwich University Hospital Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 14, 2020
• Study Start: September 8, 2020
• Primary Completion: November 30, 2024
• Study Completion: May 9, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)