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OpenTrials
Completed

NCT Number: NCT04824677

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Arnau de Vilanova, Lleida, Spain

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About this study

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:

  • Previous epidemiological data of the patient.
  • Clinical and biological data and treatment upon admission to the hospital.
  • 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
  • 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.
  • For future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the CIBER coverage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hospital treatment of COVID disease

Other

Hospital treatment of COVID disease

Primary outcomes

  1. Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)

    Time frame: 18 months

    Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).

Secondary outcomes

  1. Death

    Time frame: 18 months

    Development of a predictive model for mortality risk.

  2. Mechanical ventilation

    Time frame: 18 months

    Development of a predictive model for the need of mechanical ventilation.

  3. ICU admission

    Time frame: 18 months

    Development of a predictive model for admission at the ICU.

  4. Thrombotic event

    Time frame: 18 months

    Development of a predictive model for the risk of thrombotic events.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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