Risk Factors and Prognoses in Patients Hospitalized for COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Hospital treatment of COVID 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 Type: Observational
• Enrollment (Actual): 971

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Lleida, Spain, 25198
    • Hospital Universitari Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for COVID19.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Ferran Barbé, MD, Spanish Respiratory Society (SEPAR)

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-Ponent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No