COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
NCT04510194
COVID-19, Coronaviridae Infections
Sylmar, California, United States
View Trial DetailsNCT Number: NCT04546776
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
James Paget University Hospital Foundation Trust, Great Yarmouth, Norfolk, United Kingdom
Approaching participants will mainly be performed in two ways:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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.
Quadram Institute Bioscience
Other
Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects
Acronym: CoPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04510194
COVID-19, Coronaviridae Infections
Sylmar, California, United States
View Trial DetailsNCT04761822
Allergic Reaction, COVID-19
Tucson, Arizona, United States
View Trial DetailsNCT04895475
COVID-19, Coronaviridae Infections
Cincinnati, Ohio, United States
View Trial DetailsNCT04885452
COVID-19, Coronaviridae Infections
Agen, France
View Trial Details