Clinical trial NCT04873388: Early Predictors of Prognostic Course in Patients With COVID-19 in Critical or Semi-intensive Area.
Official title: Biomarkers and Early Predictors of Prognostic Course, Response to Possible to Possible Treatments and Risk of Over-infection in Patients With COVID-19 Hospitalized in the Critical or Semi-intensive Area.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Covid19
C-reactive Protein
Procalcitonin
D-dimer
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to intensive care areas (intensive care unit/intensive care unit) and semi-intensive care areas dedicated to the care of COVID-19 patients.

Brief summary: Although the recent literature is building a remarkable background to answer the many unknowns related to SARS-CoV-2 infection, it is absolutely necessary to finalize every clinical effort to collect data that may be useful, in a short time, to improve our knowledge of SARS-CoV-2 infection. Numerous biomarkers have been evaluated in the recent literature as being altered in patients with severe forms of COVID-19. Particularly, in the critical care area, the research of early predictors of mortality is essential for high-flow management of patients requiring invasive assisted ventilation and requiring invasive and non-invasive assisted ventilation, hemodynamic support, sometimes extracorporeal support (Extracorporeal Membrane Oxygenation, ECMO). The coordinated study of different biomarkers, in particular, if combined with each other, possibly even to constitute a possible score, could guide the correct allocation of patients between hospital departments and the appropriate management in intensive care units. appropriate management in intensive care units, as well as providing an early prognostic indication. prognostic indication. The combination of these biomarkers with routine clinical and laboratory data may further provide valuable information about their use in acute care and as progressive acute and as progressive monitoring over time.

Regarding the data of interest on the clinical trend, the evaluation of the respiratory support modalities, from the administration of oxygen therapy (by nasal cannulae or Venturi mask, or by high flow system - High Flow Nasal Cannula, HFNC), to CPAP support or by non-invasive or invasive ventilation, appears of particular importance.

Therefore, the present study will be conducted in sub-intensive as well as intensive care units, in order to evaluate different types of patients, and their possible evolution over time.

The comparison between the populations belonging to different areas of intensity of care will be able to describe the different populations. Data analysis will allow an evaluation of possible risk factors and prognostic determinants of the severity of the disease and its infectious complications.


Eligibility criteria: Inclusion Criteria:

* hospitalized patients with clinical signs and symptoms of COVID-19, confirmed by nasopharyngeal swab RT-PCR of airways positive for SARS-CoV-2
* age \> 18 years
* Hospitalization in the departments of the hospitals involved

Exclusion Criteria:

* none

Primary outcomes:
measure: ICU inpatient mortality
timeFrame: 24 months
measure: ICU inpatient length of stay
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of over-infections (bacterial, viral, fungal), particularly of bacteremia and pneumonias associated with mechanical ventilation; observed infections' microbiological characteristics.
timeFrame: 24 months
Other outcomes:
measure: Identification of prognostic factors (biomarkers, clinical scores, respiratory support modalities, others).
timeFrame: 24 months
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: University of Torino
name: Luca Brazzi, Professor
role: STUDY_CHAIR
References: