Oral Health, Microbial Burden and COVID-19

• Conditions: Covid19; Periodontitis
• Interventions: Other: Swab

• Registration Number: NCT04668911
• Lead Sponsor: Eastman Dental Insitute and Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study Start: 2020-12-13
• Study First Posted: 2020-12-16
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit)	Swab	-
Controls tested PCR (-) for COVID-19	Swab	-
Tested PCR (+) for COVID-19, Mild - not admitted to the hospital	Swab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

University College Hospital (UCH), UCL Eastman Dental Institute; 🇬🇧 London, United Kingdom