Covid19ORACLENCT04668911
Oral Health, Microbial Burden and COVID-19
An observational study of Covid19 and Periodontitis, run by Eastman Dental Insitute and Hospital at 1 site in United Kingdom.
Trial summary
An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls. Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Periodontitis
- What is being tested?
- Swab
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2020to 12 Dec 2021
- 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: Adults who tested (PCR) positive or negative for SARS-CoV2 infection
Who may be able to join
- Must provide written informed consent
- Subjects have to be tested (PCR) positive or negative for SARS-CoV2 infection
- Must be able to provide oral and nasal swabbing within 48 hours of polymerise chain reaction (PCR) test results
Who cannot join
- Under the age of 18 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital (UCH), UCL Eastman Dental Institute
London
Francesco D'Aiuto, DMD, PhD, MClinDent, f.daiuto@ucl.ac.uk
Francesco D'Aiuto, DMD, PhD, MClinDent
About this study
An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls.
Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls).
- Conditions
- Covid19, Periodontitis
- Being tested
- Swab
- Keywords
- COVID-19, Human microbiome, Oral microbiome, SARS-CoV-2 infection
- Medical subject headings
- COVID-19, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwabOther
PCR test for SARS-CoV2, oral and nasal swab
| Study group | Role | What they receive |
|---|---|---|
| Controls tested PCR (-) for COVID-19 | Not described Receives: Other: Swab | |
| Tested PCR (+) for COVID-19, Mild - not admitted to the hospital | Not described Receives: Other: Swab | |
| Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit) | Not described Receives: Other: Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbial signature
To assess the oral microbial signatures that relates to SARS-CoV2 in patients with no, mild and severe disease.
Measured: Day 1
Secondary outcomes (1)
Nasal microbial signature
To assess the nasal microbial signatures related to SARS-CoV2 in patients with no, mild and severe disease and to assess the role of the oral expression of ACE2-Ang II system during SARS-CoV2 in relation to disease outcome (mild, severe COVID).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start13 Dec 2020
- Primary completion12 Dec 2021 (estimated)
- Study completion12 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastman Dental Insitute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DermBiont, Inc., University College London Hospitals, The Whittington Hospital NHS Trust
- Responsible party
- Principal investigator, Prof Francesco D'Aiuto, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668911
- Sponsor's protocol ID
- EDGE 132868
- Other IDs
- 283766
- Acronym
- ORACLE
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health, Microbial Burden and COVID-19
- ClinicalTrials.gov ID
- NCT04668911
- Acronym / sponsor ID
- ORACLE / EDGE 132868
- Conditions
- Covid19, Periodontitis
- Keywords
- COVID-19, Human microbiome, Oral microbiome, SARS-CoV-2 infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eastman Dental Insitute and HospitalUniversity, hospital or other
- Collaborators
- DermBiont, Inc., University College London Hospitals, The Whittington Hospital NHS Trust
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 12 Dec 2021 (estimated)
- Study completion
- 12 Dec 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls.
Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls tested PCR (-) for COVID-19 | – | Other: Swab |
| Tested PCR (+) for COVID-19, Mild - not admitted to the hospital | – | Other: Swab |
| Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit) | – | Other: Swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who tested (PCR) positive or negative for SARS-CoV2 infection
Key inclusion criteria (3 listed)
- Must provide written informed consent
- Subjects have to be tested (PCR) positive or negative for SARS-CoV2 infection
- Must be able to provide oral and nasal swabbing within 48 hours of polymerise chain reaction (PCR) test results
Key exclusion criteria (1 listed)
- Under the age of 18 years old
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 |
|---|---|---|
| SwabPCR test for SARS-CoV2, oral and nasal swab | Other | Controls tested PCR (-) for COVID-19, Tested PCR (+) for COVID-19, Mild - not admitted to the hospital, Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit) |
Primary outcome
Oral microbial signature
Time frame: Day 1
To assess the oral microbial signatures that relates to SARS-CoV2 in patients with no, mild and severe disease.
1 secondary outcome
Nasal microbial signature
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Covid19 and Periodontitis, run by Eastman Dental Insitute and Hospital 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 3 inclusion and 1 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 4 Feb 2021. 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 Jeanie Suvan (+442034561108, j.suvan@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbial signature (time frame: Day 1). 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 4 Feb 2021.