COVID-19MIMSANCT05212766
Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease
An observational study of COVID-19 and Microbial Colonization, run by King's College London at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Microbial Colonization, Oral Disease
- What is being tested?
- COVID infection, COVID vaccination and Oral examination
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- • 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.
Who cannot join
- • 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Trust / King's College London
London, SE1 9RT
Mark Ide, PhD, mark.ide@kcl.ac.uk
About this study
Official title: Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease: Diagnostic/Prognostic Utility in South Asian Populations
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
Read the 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
- Conditions
- COVID-19, Microbial Colonization, Oral Disease, Periodontal Diseases, Innate Inflammatory Response, Mucosal Infection
- Being tested
- COVID infection, COVID vaccination, Oral examination
- Keywords
- COVID-19, periodontal disease, oral health, mucosal immunity
- Medical subject headings
- COVID-19, Communicable Diseases, Mouth Diseases, Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID infectionBiological
Infections with COVID 19
COVID vaccinationBiological
Vaccination against COVID 19
Oral examinationDiagnostic test
Assessment of oral and periodontal health status
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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 Receives: Biological: COVID infection; Biological: COVID vaccination; Diagnostic Test: Oral examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups
Multiple assessments
Measured: 16 weeks
Secondary outcomes (2)
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
Measured: 16 weeks
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Apr 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, UK Research and Innovation
- Responsible party
- Sponsor
- Investigators
- Stephen J Challacombe, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212766
- Sponsor's protocol ID
- MIMSA
- Acronym
- MIMSA
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is likely that anonymised data may be shared with colleagues carrying out a linked study in India, although the exact nature of this yet to be confirmed
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease: Diagnostic/Prognostic Utility in South Asian Populations
- ClinicalTrials.gov ID
- NCT05212766
- Acronym / sponsor ID
- MIMSA / MIMSA
- Conditions
- COVID-19, Microbial Colonization, Oral Disease, Periodontal Diseases, Innate Inflammatory Response, Mucosal Infection
- Keywords
- COVID-19, periodontal disease, oral health, mucosal immunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, UK Research and Innovation
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Vaccinated or unvaccinated uninfected South Asian ethnicity | – | Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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. |
| Asymptomatic / mild infected South Asian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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 |
| Symptomatic infected South Asian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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. |
| Infected recovered South Asian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of South Asian ethnicity. |
| Vaccinated or unvaccinated uninfected Caucasian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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. |
| Asymptomatic / mild infected Caucasian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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 |
| Symptomatic infected Caucasian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants 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. |
| Infected recovered Caucasian ethnicity | – | Biological: COVID infection, Biological: COVID vaccination, Diagnostic Test: Oral examinationParticipants will have experienced moderate or severe symptomatic infection (positive test, admission) and recovered. They will identify as of Caucasian ethnicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- • South Asian and White British persons and those diagnosed with symptomatic or asymptomatic COVID-19 infection.
Key exclusion criteria (10 listed)
- • 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID infectionInfections with COVID 19 | Biological | 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 vaccinationVaccination against COVID 19 | Biological | 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 examinationAssessment of oral and periodontal health status | Diagnostic test | 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 |
Primary outcome
Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups
Time frame: 16 weeks
Multiple assessments
2 secondary outcomes
Impact of immunity and oral microbiome
Time frame: 16 weeks
Impact of pre-existing oral disease
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided. It is likely that anonymised data may be shared with colleagues carrying out a linked study in India, although the exact nature of this yet to be confirmed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Challacombe, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Microbial Colonization, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen J Challacombe, PhD (02971887188, stephen.challacombe@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.