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Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease

Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Eligibility

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).

Exclusion criteria summary:

  • 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.

Study details
    COVID-19
    Microbial Colonization
    Oral Disease
    Periodontal Diseases
    Innate Inflammatory Response
    Mucosal Infection

NCT05212766

King's College London

28 January 2024

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