COVID-19, Microbial Colonization, Oral Disease, Periodontal Diseases, Innate Inflammatory Response, Mucosal Infection
Conditions
Keywords
COVID-19, periodontal disease, oral health, mucosal immunity
Brief summary
Determining whether in the mouth there are differences between the participant groups in the nature and activity of mucosal innate immunity, in immune responses to SARS-COV2 antigens, or in the oral microbiome
Detailed description
Cross sectional with longitudinal component * 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
Interventions
BIOLOGICALCOVID infection
Infections with COVID 19
BIOLOGICALCOVID vaccination
Vaccination against COVID 19
DIAGNOSTIC_TESTOral examination
Assessment of oral and periodontal health status
Sponsors
Guy's and St Thomas' NHS Foundation Trust
UK Research and Innovation
King's College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • South Asian and White British persons and those diagnosed with symptomatic or asymptomatic COVID-19 infection. * 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
* • Those patients unwilling to participate, those unable to understand sufficiently to give informed consent and those unable to participate due to the severity of COVID-19 disease. Those patients classified as not either South Asian or White British heritage. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups | 16 weeks | Multiple assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of immunity and oral microbiome | 16 weeks | To determine whether the presence of pre-existing oral disease is related to susceptibility to SARS-CoV2 infection, to severity of COVID-19 disease or relates to the nature of mucosal immunity and to the composition and activity of the oral microbiome |
| Impact of pre-existing oral disease | 16 weeks | To determine whether the presence of pre-existing oral disease is related to susceptibility to SARS-CoV2 infection, to severity of COVID-19 disease or relates to the nature of mucosal immunity and to the composition and activity of the oral microbiome |
Countries
United Kingdom
Contacts
Primary ContactStephen J Challacombe, PhD
Backup ContactMark Ide, PhD
Outcome results
None listed