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| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| UK Research and Innovation | OTHER |
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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
Cross sectional with longitudinal component
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
| |
| 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. |
| |
| Infected recovered South Asian ethnicity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID infection | Biological | Infections with COVID 19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between oral mucosal immunity and microbiome on COVID outcomes in different ethnic groups | Multiple assessments | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impact of pre-existing oral disease |
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Inclusion Criteria:
• South Asian and White British persons and those diagnosed with symptomatic or asymptomatic COVID-19 infection.
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.
Exclusion criteria summary:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen J Challacombe, PhD | Contact | 02971887188 | stephen.challacombe@kcl.ac.uk | |
| Mark Ide, PhD | Contact | 01711887188 | mark.ide@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen J Challacombe, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Trust / King's College London | Recruiting | London | SE1 9RT | United Kingdom |
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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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003141 | Communicable Diseases |
| D009059 | Mouth Diseases |
| D010510 | Periodontal Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood Whole mouth fluid
Participants 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 | 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. |
|
| 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 |
|
| 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. |
|
| 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 |
|
| COVID vaccination | Biological | Vaccination against COVID 19 |
|
| Oral examination | Diagnostic Test | Assessment of oral and periodontal health status |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009057 | Stomatognathic Diseases |