Clinical trial NCT04824677: Risk Factors and Prognoses in Patients Hospitalized for COVID-19
Official title: Risk Factors and Prognoses in Patients Hospitalized for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)
timeFrame: 18 months
Secondary outcomes:
measure: Death
timeFrame: 18 months
measure: Mechanical ventilation
timeFrame: 18 months
measure: ICU admission
timeFrame: 18 months
measure: Thrombotic event
timeFrame: 18 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Lleida
country: Spain
facility: Hospital Universitari Santa Maria
Study officials:
affiliation: Spanish Respiratory Society (SEPAR)
name: Ferran Barbé, MD
role: PRINCIPAL_INVESTIGATOR
References: