Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

971 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Hospital treatment of COVID disease

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ferran Barbe

Chair Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferran Barbé, MD

Role: PRINCIPAL_INVESTIGATOR

Spanish Respiratory Society (SEPAR)

Locations

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Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital Universitari Santa Maria

Lleida, , Spain

Site Status

Countries

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Spain

References

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Belmonte T, Perez-Pons M, Benitez ID, Molinero M, Garcia-Hidalgo MC, Rodriguez-Munoz C, Gort-Paniello C, Moncusi-Moix A, Made A, Devaux Y, Martelli F, Ortega A, Gonzalez J, Torres G, Barbe F, de Gonzalo-Calvo D. Addressing the unsolved challenges in microRNA-based biomarker development: Suitable endogenous reference microRNAs for SARS-CoV-2 infection severity. Int J Biol Macromol. 2024 Jun;269(Pt 2):131926. doi: 10.1016/j.ijbiomac.2024.131926. Epub 2024 Apr 28.

Reference Type DERIVED

PMID: 38688344 (View on PubMed)

Other Identifiers

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COVID-Ponent

Identifier Type: -

Identifier Source: org_study_id