COVID-19 Clinical Status Associated With Outcome Severity: An Unsupervised Machine Learning Approach

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT05119465
Collaborator
(none)
268
1
19.9
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    An algorithmic pipeline based on unsupervised machine learning algorithms, which aims to operate in tandem with physicians and provide additional knowledge for the proper categorization of COVID-19 infected patients based on their severity, is proposed in this study. Data from patients hospitalized in our clinic are collected and stored in separate Microsoft Excel files (.xlsx), which are loaded into memory. A script is concatenating them all into a single dataframe where they are checked for NaN (Not a Number) values. Because of the nature of the data, patients with missing information are discarded entirely from the dataset, since information inference would be a biased practice for the particular application. Next, we apply data normalization by scaling all numerical variables between the (0,1) range, so that the range of all numerical variables is the same, and any bias towards certain variables is avoided .A thorough and detailed data collection process was designed in order to collect information for the patients, without disturbing the clinical treatment, or upsetting them in the process.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    268 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Does Corona Virus Disease (COVID)-19 Clinical Status Associates With Outcome Severity?An Unsupervised Machine Learning Approach for Knowledge Extraction
    Actual Study Start Date :
    Nov 1, 2019
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Group

    Hospitalized Patients with Corona virus disease

    Outcome Measures

    Primary Outcome Measures

    1. Cluster of patients depending on severity of infection [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients that came into emergency department and diagnosed with COVID-19 infection
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University General Hospital of Thessaloniki AHEPA ThessalonĂ­ki Greece 54621

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Triantafyllos Didangelos, Associate Professor of Internal Medicine-Diabetology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT05119465
    Other Study ID Numbers:
    • 19400_21052021
    First Posted:
    Nov 15, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Triantafyllos Didangelos, Associate Professor of Internal Medicine-Diabetology, Aristotle University Of Thessaloniki
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021