NCT06070896

Brief Summary

The various epidemics that health systems periodically suffers require having valid and detailed information on its evolution and predictions in the short, medium and long term in real time to allow the health system to organize itself in advance to be able to address the health and sanitary problem that this entails.The objectives of this proposal are: to study the usefulness of the health system's information and data storage system as a source for quickly and efficiently obtaining data necessary for modeling an epidemiological outbreak; its modeling in order to predict its evolution and the presentation of results to help in decision making. The investigatorswill rely on the experience obtained so far during the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, to define semi-automatic and flexible criteria for searching, extracting, cleaning and aggregating data. Predictions of incidence, number of hospital and ICU admissions, and number of deaths will be made at the Basque Country level.Within the analysis of temporal data, especially in the context of the pandemic, it is essential to have robust tools that allow accurate predictions. In this study, the investigators employed P-splines based on the negative binomial distribution to predict pandemic-related positive cases, hospital admissions, and ICU admissions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
715,206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 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

March 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 28, 2024

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

October 5, 2023

Last Update Submit

February 27, 2024

Conditions

Keywords

COVID-19Mathematical ModelPublic Health

Outcome Measures

Primary Outcomes (3)

  • COVID19 positive cases

    Number of estimated positive COVID19 cases by age and day.

    Daily

  • COVID19 hospital admissions

    Number of estimated COVID19 hospital admissions by age and day.

    Daily

  • Deaths due to COVID19

    Number of total deaths due to COVID19 estimated by age and day.

    Daily

Secondary Outcomes (1)

  • ICU admissions

    Daily

Eligibility Criteria

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

Information collected on daily incidence data aggregated by age and sex for: positive cases, hospital admissions and ICU admissions by SARS-CoV-2, hospital discharges and ICU discharges, recovered and mortality (in ICU, in hospital or in the community) of individuals with COVID19).

You may qualify if:

  • To be a positive SARS-CoV-2 infection laboratory-confirmed by a positive result on the reverse transcriptase-polymerase chain reaction assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or a positive antigen test from March 1, 2020 to January 9, 2022
  • For hospital admissions:
  • Consider different episodes as a single admission when it comes to transfers from one center to another.
  • Exclusively admissions due to COVID-19.

You may not qualify if:

  • Patients admitted for other reasons who have developed the disease during their hospital stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, 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

  • Inmaculada Arostegui, PhD

    Basque University

    STUDY CHAIR
  • Dae Jin Lee, PhD

    BCAM

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 6, 2023

Study Start

March 1, 2020

Primary Completion

September 30, 2022

Study Completion

December 31, 2023

Last Updated

February 28, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations