ORACLE: Oral Health, Microbial Burden and COVID-19

• Sponsor: Eastman Dental Insitute and Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04668911
• Collaborator: DermBiont, Inc. (Industry), University College London Hospitals (Other), The Whittington Hospital NHS Trust (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Covid19; Periodontitis	Other: Swab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Oral Health, Microbial Burden and COVID-19
• Actual Study Start Date: Dec 13, 2020
• Anticipated Primary Completion Date: Dec 12, 2021
• Anticipated Study Completion Date: Dec 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Controls tested PCR (-) for COVID-19	Other: Swab; PCR test for SARS-CoV2, oral and nasal swab
Tested PCR (+) for COVID-19, Mild - not admitted to the hospital	Other: Swab; PCR test for SARS-CoV2, oral and nasal swab
Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit)	Other: Swab; PCR test for SARS-CoV2, oral and nasal swab

Outcome Measures

Primary Outcome Measures

1. Oral microbial signature [Day 1]

   To assess the oral microbial signatures that relates to SARS-CoV2 in patients with no, mild and severe disease.

Secondary Outcome Measures

1. Nasal microbial signature [Day 1]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Must provide written informed consent

2. Subjects have to be tested (PCR) positive or negative for SARS-CoV2 infection

3. Must be able to provide oral and nasal swabbing within 48 hours of polymerise chain reaction (PCR) test results

Exclusion Criteria:

1. Under the age of 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College Hospital (UCH), UCL Eastman Dental Institute	London		United Kingdom

Sponsors and Collaborators

• Eastman Dental Insitute and Hospital
• DermBiont, Inc.
• University College London Hospitals
• The Whittington Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof Francesco D'Aiuto, Professor, University College, London
• ClinicalTrials.gov Identifier: NCT04668911
• Other Study ID Numbers: EDGE 132868; 283766
• First Posted: Dec 16, 2020
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof Francesco D'Aiuto, Professor, University College, London: COVID-19; Human microbiome; Oral microbiome; SARS-CoV-2 infection
• Additional relevant MeSH terms: COVID-19; Periodontitis

Study Results

No Results Posted as of Feb 4, 2021