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

Launched by KING'S COLLEGE LONDON · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how the health of the mouth, particularly the germs that live there (called the oral microbiome), and the body's immune responses might be linked to COVID-19. Researchers want to find out if there are differences in these factors between people with and without COVID-19. The study aims to learn more about how the mouth’s immunity reacts to the virus that causes COVID-19 and if this affects the disease's severity.

To participate, individuals need to be at least 18 years old, and they can either be confirmed COVID-19 patients (recently diagnosed) or healthy individuals who have never had COVID-19. The trial is open to South Asian and White British groups, regardless of other health conditions like diabetes or heart disease. Participants will be asked to provide saliva and blood samples and will undergo an oral examination. It's important to note that those who are critically ill or unable to provide consent, as well as those who are pregnant or have certain serious health conditions, cannot take part. This trial is currently recruiting participants, and your involvement could help improve our understanding of COVID-19 and its effects.

Gender

ALL

Eligibility criteria

• 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.