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

COVID-19 Clinical Trial

— MIMSA  

Official title:

Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease: Diagnostic/Prognostic Utility in South Asian Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05212766
• Other study ID #: MIMSA
• Status: Recruiting
• Start date: April 7, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: Stephen J Challacombe, PhD
• Phone: 02971887188
• Email: stephen.challacombe[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

• Oral disease questionnaire and clinical examination

• Separation of SWMF into pellet for DNA extraction for microbiomics and supernatant for cell phenotype analysis, cytokines and antibodies to SARS-CoV2 antigens

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Inflammation
• Microbial Colonization
• Mouth Diseases
• Mucosal Infection
• Oral Disease
• Periodontal Diseases

Intervention

Biological:
• COVID infection
Infections with COVID 19
• COVID vaccination
Vaccination against COVID 19

Diagnostic Test:
• Oral examination
Assessment of oral and periodontal health status

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Trust / King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust, UK Research and Innovation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups	Multiple assessments	16 weeks
Secondary	Impact of immunity and oral microbiome	To determine whether the presence of pre-existing oral disease is related to susceptibility to SARS-CoV2 infection, to severity of COVID-19 disease or relates to the nature of mucosal immunity and to the composition and activity of the oral microbiome	16 weeks
Secondary	Impact of pre-existing oral disease	To determine whether the presence of pre-existing oral disease is related to susceptibility to SARS-CoV2 infection, to severity of COVID-19 disease or relates to the nature of mucosal immunity and to the composition and activity of the oral microbiome	16 weeks