Status:
UNKNOWN
Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
UK Research and Innovation
Conditions:
COVID-19
Microbial Colonization
Eligibility:
All Genders
18+ years
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 m...
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. *...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
April 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05212766
Start Date
April 7 2022
End Date
December 30 2024
Last Update
October 10 2023
Active Locations (1)
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1
Guy's and St Thomas' NHS Trust / King's College London
London, United Kingdom, SE1 9RT