NCT04569851

Brief Summary

This is a multicenter, non-interventional, retrospective study using data captured in the EHRs (Electronic Health Records) of the participating hospital sites to determine factors that predict disease prognosis and outcomes in COVID-19 patients, specifically: Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanical ventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/ hospital discharge, in-hospital death)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

May 1, 2026

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

April 11, 2020

Last Update Submit

April 27, 2026

Conditions

COVID-19 Infection

Keywords

Artificial IntelligenceElectronic health recordIntensive care unitNatural language processingMachine LearningReal-world evidenceSARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2)COVID-19

Outcome Measures

Primary Outcomes (2)

  • Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization

    All variables and outcomes will be extracted from the free-text narratives available in patients' EHRs Hospitalization * Percentage of hospitalized patients at diagnosis * Percentage of hospitalized patients after diagnosis * Percentage of non-hospitalized patients * Percentage of patients admitted to the ICU Disease outcome: Cure/Hospital Discharge/In-hospital death * Percentage of patients who have been discharged

    From 1st Jan 2020

  • Factors that predict disease prognosis and outcomes in COVID-19 patients - ICU

    Transfer to ICU and/or need for medical ventilation * Time (in days) from diagnosis to ICU admission * Time (in days) from the date of first symptom to ICU admission * Time (in days) from hospital admission to ICU admission (in hospitalized patients) Percentage of patients not admitted to the ICU Length of ICU stay * Length of ICU stay (mean duration in days across all patients)

    From 1st Jan 2020

Secondary Outcomes (34)

  • The demographic and clinical characteristics of COVID-19 patients

    From 1st Jan 2020

  • The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis

    From 1st Jan 2020

  • The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range

    From 1st Jan 2020

  • The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results

    From 1st Jan 2020

  • The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis

    From 1st Jan 2020

  • +29 more secondary outcomes

Eligibility Criteria

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

The study population will consist of all patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites. Among the suspected COVID-19 cases, we will determine the following: * Confirmed positive cases (i.e., all patients who tested positive for COVID-19 ). * Confirmed negative cases (i.e., all patients who tested negative for COVID-19) * Possible cases (i.e., all patients with suspected COVID-19 but no/pending test results) To determine the characteristics of the patients according to their clinical outcome, we will study both the confirmed positive cases and all possible classes (with no/pending laboratory results) subpopulations

You may qualify if:

  • All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.

You may not qualify if:

  • Not suspected COVID-10 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Guadalajara

Guadalajara, Guadalajara, Spain

Location

Hospital Universitario La Princesa

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • José Luis Izquierdo, MD, PhD

    University of Guadalajara

    STUDY CHAIR

  • Joan B Soriano, MD, PhD

    Hospital Universitario La Princesa

    STUDY CHAIR

  • Julio Ancochea, MD, PhD

    Hospital Universitario La Princesa

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2020

First Posted

September 30, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2023

Study Completion

February 28, 2024

Last Updated

May 1, 2026

Record last verified: 2024-11

Locations

ES(2)