NCT05124587

Brief Summary

The study aims to develop and externally validate a prediction model for the critical outcomes of COVID-19 patients using predictors which can be easily obtained in clinical practice, including patients' demographic characteristics, self-reported medical conditions, and oral health.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 17, 2021

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Critical outcomes of COVID-19

    The critical outcomes include death, and ICU admission

    March 2020 and May 2021

Study Arms (1)

Patients with confirmed COVID-19 in the hospital setting

Other: No intervention group

Interventions

No intervention group

Patients with confirmed COVID-19 in the hospital setting

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients were diagnosed as COVID-19 from the Isala Hospital (Zwolle, the Netherlands) or from Noordwest Ziekenhuis (NWZ) (Alkmaar, the Netherlands).

You may qualify if:

  • patients who had a diagnosis of COVID-19 in the hospitals who visited the Department of Oral and Maxillofacial Surgery (OMFS) between March 2020 and May 2021, if they have had a dental panoramic radiograph (OPG), obtained up to a maximum of 5 years until the end of the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Noordwest Ziekenhuis (NWZ)

Alkmaar, Netherlands

Location

Isala Hospital

Zwolle, Netherlands

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 17, 2021

First Posted

November 18, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations