Optic

ID

Name

MIMSA

Description

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

Trial arms

Trial start

2022-04-07

Estimated PCD

2023-10-30

Trial end

2024-12-30

Status

Recruiting

Treatment

COVID infection

Infections with COVID 19

Arms:

Asymptomatic / mild infected Caucasian ethnicity, Asymptomatic / mild infected South Asian ethnicity, Infected recovered Caucasian ethnicity, Infected recovered South Asian ethnicity, Symptomatic infected Caucasian ethnicity, Symptomatic infected South Asian ethnicity, Vaccinated or unvaccinated uninfected Caucasian ethnicity

COVID vaccination

Vaccination against COVID 19

Arms:

Asymptomatic / mild infected Caucasian ethnicity, Asymptomatic / mild infected South Asian ethnicity, Infected recovered Caucasian ethnicity, Infected recovered South Asian ethnicity, Symptomatic infected Caucasian ethnicity, Symptomatic infected South Asian ethnicity, Vaccinated or unvaccinated uninfected Caucasian ethnicity, Vaccinated or unvaccinated uninfected South Asian ethnicity

Oral examination

Assessment of oral and periodontal health status

Arms:

Asymptomatic / mild infected Caucasian ethnicity, Asymptomatic / mild infected South Asian ethnicity, Infected recovered Caucasian ethnicity, Infected recovered South Asian ethnicity, Symptomatic infected Caucasian ethnicity, Symptomatic infected South Asian ethnicity, Vaccinated or unvaccinated uninfected Caucasian ethnicity, Vaccinated or unvaccinated uninfected South Asian ethnicity

Size

750

Primary endpoint

Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups

16 weeks

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Whole mouth fluid'}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}

Updated at

2023-10-10

Organization

King's College London

Product

COVID

Indication

COVID-19

Indication

Microbial Colonization

Indication

Oral Disease