Oral Health, Microbial Burden and COVID-19 (ORACLE)

February 2, 2021 updated by: Prof Francesco D'Aiuto, Eastman Dental Insitute and Hospital

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • University College Hospital (UCH), UCL Eastman Dental Institute
        • Contact:
        • Principal Investigator:
          • Francesco D'Aiuto, DMD, PhD, MClinDent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults who tested (PCR) positive or negative for SARS-CoV2 infection

Description

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:

a. Under the age of 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal microbial signature
Time Frame: 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).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastman Dental Insitute and Hospital

Collaborators

University College London Hospitals
The Whittington Hospital NHS Trust
DermBiont, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2020

Primary Completion (Anticipated)

December 12, 2021

Study Completion (Anticipated)

December 12, 2021

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDGE 132868
  • 283766 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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