Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Covid19 Clinical Trial

Official title:

Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824677
• Other study ID #: COVID-Ponent
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Hospital treatment of COVID disease
Hospital treatment of COVID disease

Locations

Country	Name	City	State
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital Universitari Santa Maria	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)	Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).	18 months
Secondary	Death	Development of a predictive model for mortality risk.	18 months
Secondary	Mechanical ventilation	Development of a predictive model for the need of mechanical ventilation.	18 months
Secondary	ICU admission	Development of a predictive model for admission at the ICU.	18 months
Secondary	Thrombotic event	Development of a predictive model for the risk of thrombotic events.	18 months