ClinicalTrials.gg
Status unknownNCT04873388Updated Aug 1, 2023

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

An observational study in Covid19, C-reactive Protein and Procalcitonin, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by University of Turin, Italy · Observational

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

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In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 150 is below the median of 260 across 3,188 observational studies indexed under COVID-19.

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Lead sponsor

University of Turin, Italy is the lead sponsor of 213 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. ICU inpatient mortality

    Time frame: 24 months

  2. ICU inpatient length of stay

    Time frame: 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.

    Time frame: 24 months

Other outcomes

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

    Time frame: 24 months

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Study locations

1 site
  • AOU Città della Salute e della Scienza di Torino
    Torino, 10100, Italy
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References and documents

Publications

  • 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. PubMed 39916726 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04873388
Responsible party
Sponsor
First posted
May 5, 2021
Start date
Mar 1, 2020
Primary completion
May 1, 2021
Completion
Dec 31, 2024 (estimated)
Last update
Aug 1, 2023

Study contacts

Luca Brazzi, Professor
study chair · University of Torino

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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