Skip to content

Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Risk Factors and Prognoses in Patients Hospitalized for COVID-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04824677
Enrollment
971
Registered
2021-04-01
Start date
2020-05-18
Completion date
2022-12-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

OTHERHospital treatment of COVID disease

Hospital treatment of COVID disease

Sponsors

Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)18 monthsDevelopment of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).

Secondary

MeasureTime frameDescription
Death18 monthsDevelopment of a predictive model for mortality risk.
Mechanical ventilation18 monthsDevelopment of a predictive model for the need of mechanical ventilation.
ICU admission18 monthsDevelopment of a predictive model for admission at the ICU.
Thrombotic event18 monthsDevelopment of a predictive model for the risk of thrombotic events.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026