Early Predictors of Prognostic Course in Patients With COVID-19 in Critical or Semi-intensive Area.

Covid19 Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04873388
• Other study ID #: BIO-COVID-19
• Status: Enrolling by invitation
• Start date: March 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C-reactive Protein
• COVID-19
• Covid19
• D-dimer
• Procalcitonin

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identification of prognostic factors (biomarkers, clinical scores, respiratory support modalities, others).		24 months
Primary	ICU inpatient mortality		24 months
Primary	ICU inpatient length of stay		24 months
Secondary	Incidence of over-infections (bacterial, viral, fungal), particularly of bacteremia and pneumonias associated with mechanical ventilation; observed infections' microbiological characteristics.		24 months