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

NCT05212766 | Unknown

• 1 other identifier: MIMSA
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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 microbiome

Conditions

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

Keywords

COVID-19; periodontal disease; oral health; mucosal immunity

Outcome Measures

Primary Outcomes (1)

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

  Multiple assessments

  16 weeks

Secondary Outcomes (2)

• Impact of immunity and oral microbiome

  16 weeks

• Impact of pre-existing oral disease

  16 weeks

Study Arms (8)

Vaccinated or unvaccinated uninfected South Asian ethnicity

Participants will have not experienced infection (positive test) - we will aim to recruit both vaccinated and unvaccinated individuals although the latter may be harder to recruit. They will identify as of South Asian ethnicity. Uninfected subjects, will be recruited by advertisement within KCL or social media, from non-COVID in-patients or outpatients or attending A\&E at GSTT and at SARS-CoV2 antigen testing centres and vaccination centres and at PIC sites.

Biological: COVID vaccination; Diagnostic Test: Oral examination

Asymptomatic / mild infected South Asian ethnicity

Participants will have experienced asymptomatic or mild infection (positive test). They will identify as of South Asian ethnicity. Volunteers or subjects attending SARS-CoV2 testing centres who are found to be antigen positive or In-patients who have positive Covid tests and designated as asymptomatic/mild but admitted for non-covid reasons or those attending A\&E with COVID but designated as mild/asymptomatic

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Symptomatic infected South Asian ethnicity

Participants will have experienced moderate or severe symptomatic infection (positive test, admission). They will identify as of South Asian ethnicity. Patients either seen at GSTT or admitted as in-patients to GSTT or KCH and found to be SARS-CoV2 positive by RT-PCR in nasopharyngeal samples and designated as moderate/severe on the NIH/NIMR COVID severity scale.

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Infected recovered South Asian ethnicity

Participants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of South Asian ethnicity.

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Vaccinated or unvaccinated uninfected Caucasian ethnicity

Participants will have not experienced infection (positive test) - we will aim to recruit both vaccinated and unvaccinated individuals although the latter may be harder to recruit. They will identify as of Caucasian ethnicity. Uninfected subjects, will be recruited by advertisement within KCL or social media, from non-COVID in-patients or outpatients or attending A\&E at GSTT and at SARS-CoV2 antigen testing centres and vaccination centres and at PIC sites.

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Asymptomatic / mild infected Caucasian ethnicity

Participants will have experienced asymptomatic or mild infection (positive test). They will identify as of Caucasian ethnicity. Volunteers or subjects attending SARS-CoV2 testing centres who are found to be antigen positive or In-patients who have positive Covid tests and designated as asymptomatic/mild but admitted for non-covid reasons or those attending A\&E with COVID but designated as mild/asymptomatic

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Symptomatic infected Caucasian ethnicity

Participants will have experienced moderate or severe symptomatic infection (positive test, admission). They will identify as of Caucasian ethnicity. Patients either seen at GSTT or admitted as in-patients to GSTT or KCH and found to be SARS-CoV2 positive by RT-PCR in nasopharyngeal samples and designated as moderate/severe on the NIH/NIMR COVID severity scale.

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Infected recovered Caucasian ethnicity

Participants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of Caucasian ethnicity

Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination

Interventions

COVID infection BIOLOGICAL

Infections with COVID 19

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 BIOLOGICAL

Vaccination against COVID 19

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 DIAGNOSTIC_TEST

Assessment of oral and periodontal health status

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants, both South Asian and White British will be recruited by advertisement within KCL or social media, from non-COVID in-patients or outpatients or attending A\&E at GSTT and at SARS-CoV2 antigen testing centres and vaccination centres and at PIC sites. Also patients either seen at GSTT or admitted as in-patients to GSTT or KCH and found to be SARS-CoV2 positive. Patients who have had COVID may be invited directly to participate by advertising at sites specified above or be attending either the post-COVID or ICU follow-up outpatient clinics

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• UK Research and Innovation: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Trust / King's College London

London, SE1 9RT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Whole mouth fluid

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Mouth Diseases; Periodontal Diseases; Inflammation

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephen J Challacombe, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen J Challacombe, PhD

CONTACT

02971887188; stephen.challacombe@kcl.ac.uk

Mark Ide, PhD

CONTACT

01711887188; mark.ide@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 28, 2022
• Study Start: April 7, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

GB (1)