Clinical trial NCT05212766: Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease
Official title: Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease: Diagnostic/Prognostic Utility in South Asian Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Microbial Colonization
Oral Disease
Periodontal Diseases
Innate Inflammatory Response
Mucosal Infection
Keywords: COVID-19
periodontal disease
oral health
mucosal immunity
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: UK Research and Innovation
First posted: 2022-01-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Detailed 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

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.

Primary outcomes:
measure: Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups
timeFrame: 16 weeks
Secondary outcomes:
measure: Impact of immunity and oral microbiome
timeFrame: 16 weeks
measure: Impact of pre-existing oral disease
timeFrame: 16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Trust / King's College London
Study officials:
affiliation: King's College London
name: Stephen J Challacombe, PhD
role: PRINCIPAL_INVESTIGATOR
References: