Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Completed

• Conditions: Covid19

• Registration Number: NCT04824677
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge.

Through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to COVID-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. The final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.

Detailed Description

The main objective is to develop a predictive model of adverse events in hospitalized COVID-19 patients (death, initiation of mechanical ventilation, ICU admission and thrombotic event). An additional analyses will be performed for each individualized outcome.

Metodology: Prospective case-only study. The variables that will be collected are:

1. Previous epidemiological data of the patient.

2. Clinical and biological data and treatment upon admission to the hospital.

3. Clinical and biological evolutionary data (Increases in the values of certain biological variables in a defined period of time (\> 48 h) during admission):

* Baseline epidemiological and clinical variables

* Baseline biological variables

* Complications and clinical evolutionary variables

* Evolutionary biological variables

4. Clinical evolutionary data of final outcomes, including death (at 30, 90 days and at 6 months), initiation of mechanical ventilation, ICU admission and thrombotic event.

5. For future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the CIBER coverage.

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

Inclusion Criteria

• Laboratory confirmed COVID-19 infection.
• Hospitalization in a center in the Lleida healthcare region.

Exclusion Criteria

• Patients admitted with repeatedly negative COVID-19 test results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)	18 months	Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).

Secondary Outcome Measures

Name	Time	Method
Death	18 months	Development of a predictive model for mortality risk.
Mechanical ventilation	18 months	Development of a predictive model for the need of mechanical ventilation.
ICU admission	18 months	Development of a predictive model for admission at the ICU.
Thrombotic event	18 months	Development of a predictive model for the risk of thrombotic events.

Trial Locations

Locations (2)

Hospital Universitari Santa Maria; 🇪🇸 Lleida, Spain

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain