NCT06247332

Brief Summary

The retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better managing the healthcare process for patients diagnosed with long COVID.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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

January 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

January 31, 2024

Last Update Submit

February 14, 2025

Conditions

Keywords

Long COVID-19Retrospective studyArtificial IntelligenceMental Health

Outcome Measures

Primary Outcomes (1)

  • Retrospective SENSING-AI cohort

    The retrospective SENSING-AI cohort will be fed from clinical information of 100 cases of patients with long COVID-19.

    1 month

Study Arms (1)

Retrospective Long COVID cases

The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care.

Other: Review of available clinical data sources related to use cases

Interventions

There will be a review of available clinical data sources related to use cases. In addition, this information will be complemented by a cohort of anonymized retrospective data of 100 cases obtained from the clinical information resulting from the assistance to COVID-19 patients managed by the Primary Care Health District of Sevilla Norte and the Infectious Diseases Department of the Virgen Macarena University Hospital

Retrospective Long COVID cases

Eligibility Criteria

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

The sample size for the retrospective study enough to generate a first version of the risk stratification models will be around 100 cases. The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care.

You may qualify if:

  • Legal adult
  • Diagnosed of long COVID-19 in the last year
  • With the presence of any of these symptoms:
  • Asthenia (Tiredness)
  • Dyspnea
  • Shortness of breath
  • Anxiety
  • Stress
  • Depression
  • Sleep disorder

You may not qualify if:

  • Attended to specialized care consultation
  • Was admitted in hospital in the last year due to a problem not related to the COVID complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgen Macarena University Hospital

Seville, Seville, 41009, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromePsychological Well-Being

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 7, 2024

Study Start

January 18, 2022

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

February 18, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations