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

NCT04873388 | Unknown

• 1 other identifier: BIO-COVID-19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• ICU inpatient mortality

  24 months

• ICU inpatient length of stay

  24 months

Secondary Outcomes (1)

• Incidence of over-infections (bacterial, viral, fungal), particularly of bacteremia and pneumonias associated with mechanical ventilation; observed infections' microbiological characteristics.

  24 months

Other Outcomes (1)

• Identification of prognostic factors (biomarkers, clinical scores, respiratory support modalities, others).

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10100, Italy

Location

Related Publications (1)

• 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.

  PMID: 39916726 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Results of the following assays will be retrieved for the different times of the study: * white blood cells (including data on leukocyte formula and lymphocyte subpopulations) * immunoglobulins * PCR, PCT, LDH, cardiac enzymes, NT-proBNP, ferritin * s-NA, s-K, blood glucose, renal function (creatinine, renal clearances, eGFR) * creatinine, renal clearance, eGFR * TSH, fT3, fT4 * copeptin, MR-proADM The results of the laboratory data then, correlated with the parameters of cardiorespiratory function collected during the hospital stay and integrated with the prognostic scores of clinical use (Charlson, qSOFA, SOFA, SAPSII, APACHE, etc).

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luca Brazzi, Professor

  University of Torino

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: March 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)