NCT05119465

Brief Summary

Since the beginning of the COVID-19 pandemic, 195 million people have been infected and 4.2 million have died from the disease or its side-effects. Physicians, healthcare scientists and medical staff continuously try to deal with overloaded hospital admissions, while in parallel, they try to identify meaningful correlations between the severity of infected patients with their symptoms, comorbidities and biomarkers. Artificial Intelligence (AI) and Machine Learning (ML) have been used recently in many areas related to COVID-19 healthcare. The main goal is to manage effectively the wide variety of issues related to COVID-19 and its consequences. The existing applications of ML to COVID-19 healthcare are based on supervised classification which require a labeled training dataset, serving as reference point for learning, as well as predefined classes. However, the existing knowledge about COVID-19 and its consequences is still not solid and the points of common agreement among different scientific communities are still unclear. Therefore, this study aimed to follow an unsupervised clustering approach, where prior knowledge is not required (tabula rasa). More specifically, 268 hospitalized patients at the First Propaedeutic Department of Internal Medicine of AHEPA University Hospital of Thessaloniki were assessed in terms of 40 clinical variables (numerical and categorical), leading to a high-dimensionality dataset. Dimensionality reduction was performed by applying Principal Component Analysis (PCA) on the numerical part of the dataset and Multiple Correspondence Analysis (MCA) on the categorical part of the dataset. Then, the Bayesian Information Criterion(BIC) was applied to Gaussian Mixture Models (GMM) in order to identify the optimal number of clusters, under which, the best grouping of patients occurs. The proposed methodology identified 4 clusters of patients with similar clinical characteristics. The analysis revealed a cluster of asymptomatic patients that resulted in death at a rate of 23.8%. This striking result forces us to reconsider the relationship between the severity of COVID-19 clinical symptoms and patient's mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

November 12, 2021

Last Update Submit

May 14, 2023

Conditions

Keywords

COVID-19HospitalizationMachine LearningArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Cluster of patients depending on severity of infection

    Algorithm produced with artificial intelligence and machine learning approach to classify patients according their status of COVID-19 infection

    1 year

Study Arms (1)

Group

Hospitalized Patients with Corona virus disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients that came into emergency department and diagnosed with COVID-19 infection

You may qualify if:

  • patients that came into emergency department and diagnosed with COVID-19 infection

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54621, Greece

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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine-Diabetology

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 15, 2021

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations