Oral Health, Microbial Burden and COVID-19

Covid19 Clinical Trial

— ORACLE  

Official title:

Oral Health, Microbial Burden and COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668911
• Other study ID #: EDGE 132868
• Secondary ID: 283766
• Status: Recruiting
• Start date: December 13, 2020
• Est. completion date: December 12, 2021

Study information

• Verified date: February 2021
• Source: Eastman Dental Insitute and Hospital
• Contact: Jeanie Suvan
• Phone: +442034561108
• Email: j.suvan[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Periodontitis

Intervention

Other:
• Swab
PCR test for SARS-CoV2, oral and nasal swab

Locations

Country	Name	City	State
United Kingdom	University College Hospital (UCH), UCL Eastman Dental Institute	London

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral microbial signature	To assess the oral microbial signatures that relates to SARS-CoV2 in patients with no, mild and severe disease.	Day 1
Secondary	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).	Day 1