Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease
NCT ID: NCT05212766
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
750 participants
OBSERVATIONAL
2022-04-07
2024-12-30
Brief Summary
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Detailed Description
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* Stimulated whole mouth fluid (SWMF) and blood samples from South Asian and non-Asian populations
* Controls, and COVID-19 patients in both populations.
* Oral disease questionnaire and clinical examination
* Separation of SWMF into pellet for DNA extraction for microbiomics and supernatant for cell phenotype analysis, cytokines and antibodies to SARS-CoV2 antigens
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vaccinated or unvaccinated uninfected South Asian ethnicity
Participants will have not experienced infection (positive test) - we will aim to recruit both vaccinated and unvaccinated individuals although the latter may be harder to recruit. They will identify as of South Asian ethnicity. Uninfected subjects, will be recruited by advertisement within KCL or social media, from non-COVID in-patients or outpatients or attending A\&E at GSTT and at SARS-CoV2 antigen testing centres and vaccination centres and at PIC sites.
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Asymptomatic / mild infected South Asian ethnicity
Participants will have experienced asymptomatic or mild infection (positive test). They will identify as of South Asian ethnicity. Volunteers or subjects attending SARS-CoV2 testing centres who are found to be antigen positive or In-patients who have positive Covid tests and designated as asymptomatic/mild but admitted for non-covid reasons or those attending A\&E with COVID but designated as mild/asymptomatic
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Symptomatic infected South Asian ethnicity
Participants will have experienced moderate or severe symptomatic infection (positive test, admission). They will identify as of South Asian ethnicity. Patients either seen at GSTT or admitted as in-patients to GSTT or KCH and found to be SARS-CoV2 positive by RT-PCR in nasopharyngeal samples and designated as moderate/severe on the NIH/NIMR COVID severity scale.
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Infected recovered South Asian ethnicity
Participants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of South Asian ethnicity.
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Vaccinated or unvaccinated uninfected Caucasian ethnicity
Participants will have not experienced infection (positive test) - we will aim to recruit both vaccinated and unvaccinated individuals although the latter may be harder to recruit. They will identify as of Caucasian ethnicity. Uninfected subjects, will be recruited by advertisement within KCL or social media, from non-COVID in-patients or outpatients or attending A\&E at GSTT and at SARS-CoV2 antigen testing centres and vaccination centres and at PIC sites.
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Asymptomatic / mild infected Caucasian ethnicity
Participants will have experienced asymptomatic or mild infection (positive test). They will identify as of Caucasian ethnicity. Volunteers or subjects attending SARS-CoV2 testing centres who are found to be antigen positive or In-patients who have positive Covid tests and designated as asymptomatic/mild but admitted for non-covid reasons or those attending A\&E with COVID but designated as mild/asymptomatic
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Symptomatic infected Caucasian ethnicity
Participants will have experienced moderate or severe symptomatic infection (positive test, admission). They will identify as of Caucasian ethnicity. Patients either seen at GSTT or admitted as in-patients to GSTT or KCH and found to be SARS-CoV2 positive by RT-PCR in nasopharyngeal samples and designated as moderate/severe on the NIH/NIMR COVID severity scale.
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Infected recovered Caucasian ethnicity
Participants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of Caucasian ethnicity
COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Interventions
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COVID infection
Infections with COVID 19
COVID vaccination
Vaccination against COVID 19
Oral examination
Assessment of oral and periodontal health status
Eligibility Criteria
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Inclusion Criteria
* Aged 18 or over. Able to understand and consent.
* Uninfected subjects: no history of COVID-19; not vaccinated; (negative for anti-SARS-CoV2 nucleoprotein antibodies at lab)
* For patient groups: Confirmed COVID-19 positivity, symptoms and symptom onset within the past 21 days; Be recently hospitalised with COVID-19 disease; Have COVID-19 disease proven by PCR testing for SARS-CoV-2 within the last 21 days; COVID disease severity graded as per NIH/WHO.
* Recovered groups: Have had COVID-19 disease proven by PCR testing for SARS-CoV-2. COVID disease severity graded as per WHO or NIH equivalent criteria
* Those willing to participate on a single occasion but unwilling to participate with longitudinal samples will not be excluded.
* Smoking, obesity, diabetes, heart disease, antibiotics or treatment related to COVID is not excluded.
Exclusion Criteria
* Patients with malignancy, pregnancy, long term immune suppression, inability to give informed consent, not willing or able to have oral examination.
* Diabetes not excluded but screening for diabetes will be performed: glucose will be assessed in blood/serum sample (150ul).
* Critically ill participants who cannot give informed consent
* Those who are not willing to have an oral examination, or donate blood or saliva samples.
* Those who cannot chew / drool to provide a SWMF sample due to severe/critical medical conditions
* Participants with known malignancies or who are pregnant
* Participants who are on long-term immunosuppressants (e.g. for autoimmune diseases)
* Participation in other current research that is designed to, or is expected to alter the immune response.
* Inability to communicate, understand or read English.
18 Years
ALL
Yes
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
UK Research and Innovation
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Stephen J Challacombe, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Guy's and St Thomas' NHS Trust / King's College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MIMSA
Identifier Type: -
Identifier Source: org_study_id
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