Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease (NCT05212766) | Clinical Trial Compass
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Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease
United Kingdom750 participantsStarted 2022-04-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 performe…
What they're measuring
1
Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups