NCT04668911

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

December 11, 2020

Last Update Submit

February 2, 2021

Conditions

Covid19Periodontitis

Keywords

COVID-19Human microbiomeOral microbiomeSARS-CoV-2 infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Nasal microbial signature

    Day 1

Study Arms (3)

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

Interventions

SwabOTHER

PCR test for SARS-CoV2, oral and nasal swab

Controls tested PCR (-) for COVID-19Tested PCR (+) for COVID-19, Mild - not admitted to the hospitalTested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • a. Under the age of 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital (UCH), UCL Eastman Dental Institute

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral and nasal swab

MeSH Terms

Conditions

COVID-19Periodontitis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Jeanie Suvan

CONTACT

+442034561108j.suvan@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 16, 2020

Study Start

December 13, 2020

Primary Completion

December 12, 2021

Study Completion

December 12, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

GB(1)