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

NCT ID: NCT04873388

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Covid19; C-reactive Protein; Procalcitonin; D-dimer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Brazzi, Professor

Role: STUDY_CHAIR

University of Torino

Locations

AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Countries

Italy

References

Montrucchio G, Balzani E, Sales G, Bolla C, Sarda C, Della Selva A, Perotto M, Pomero F, Ravera E, Rumbolo F, Callegari T, Fanelli V, Mengozzi G, Brazzi L. Critical and non-critical coronavirus disease 2019 patients: which is the most predictive biomarker for disease severity and outcome?: A multicentre prospective cohort study comparing mid-regional pro-adrenomedullin, inflammatory and immunological patterns. Eur J Anaesthesiol Intensive Care. 2023 Nov 21;2(6):e0039. doi: 10.1097/EA9.0000000000000039. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 39916726 (View on PubMed)

Other Identifiers

BIO-COVID-19

Identifier Type: -

Identifier Source: org_study_id