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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.
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):
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital treatment of COVID disease | Other | Hospital treatment of COVID disease |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the participating centers of the Lleida health region, with a positive laboratory diagnosis for COVID19.
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| Name | Affiliation | Role |
|---|---|---|
| Ferran Barbé, MD | Spanish Respiratory Society (SEPAR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain | |||
| Hospital Universitari Santa Maria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38688344 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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1 tube EDTA
| 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 |
| Lleida |
| 25198 |
| Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |