Clinical trial NCT05162534: Independent Predictors on Clinical Outcomes in SARS-CoV2 Patients
Official title: Evaluation of Independent Clinical- Laboratory Predictors of Clinical Outcomes in Hospitalized Positive SARS-CoV2 Patients (Outcomes SARS-CoV2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Patients
Keywords: COVID-19
SARS-CoV-2
mortality risk prediction
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
First posted: 2021-12-17
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We evaluated the differences between subjects in terms of the three major COVID-19 outcomes (1. IoC=intensification of care, meant as the need for non-invasive mechanical ventilation or for endotracheal intubation; 2. in-hospital death; 3. 30-day death).

Brief summary: The clinical spectrum of COVID-19 can be very heterogeneous: from mild flu-like symptoms, to the form with severe pulmonary impairment (dyspnoea, tachypnoea, PaO2 / FiO2 ratio below 300 at arterial blood gas sampling, pulmonary infiltrates covering more than 50% of the respiratory surface); up to 5% of patients tend to rapidly develop acute respiratory distress syndrome (ARDS) with or without acute cardiac damage, underlying a phase of systemic hyperinflammation (cytokine storm) that may result in shock, multi-organ failure and death

Detailed description: AIM OF THE STUDY The purpose of the study is to evaluate the existence of prognostic indices of the disease starting from the anamnestic, clinical and laboratory data of the patients belonging to the medical departments of the S. Anna Hospital in Cona (Fe), partially dedicated to COVID-19 patients.

OBJECTIVES

Primary:

• Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients tested positive for SARS-CoV-2 infection

Secondary:

* Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients with SARS-CoV-2 infection
* Evaluation of organ damage by collecting the main organ-specific damage indices (TnI HS, CPK, LDH, ALT, isoamylase, creatinine) associated with SARS-CoV-2 infection.

METHODS The retrospective observational study will be conducted from March 2020 to May 2020 in the medical departments of Internal Medicine, Pulmonology and in the Intensive Care Units of the S.Anna Hospital in Cona (Fe), Italy.

Participants will be recruited from patients belonging to the facilities of the semi-intensive and intensive medical departments of the health company of Ferrara's province.

Anamnestic, clinical and laboratory data will be collected from the medical records of hospitalized patients. All patients of both sexes, over the age of 18 admitted to the above medical wards, with confirmed positivity to the nasopharyngeal swab for SARS-CoV-2 will be recruited.

INCLUSION CRITERIA

* Males and Females older than 18 years
* Infection by SARS-CoV-2 confirmed with at least one positive naso-pharyngeal swab
* Patient hospitalized for COVID-19 in the medical ward, semi-intensive and intensive

EXCLUSION CRITERIA

* Patients younger than 18 years
* Doubtful or unconfirmed swab detection of SARS-CoV-2 The study did not require the collection of written or verbal consent: for its drafting, in fact, only anamnestic and laboratory data were obtained, without needing to collect biological samples.

We have decided to enroll in the study the patients hospitalized for COVID-19 in the departments of internal medicine, pulmonology and in the intensive care units of the province of Ferrara.

Clinical surveillance: Evaluation of anamnestic and laboratory data extrapolated from the medical records of individual patients.

Eligibility criteria: INCLUSION CRITERIA Males and Females older than 18 years Infection by SARS-CoV-2 confirmed with at least one positive naso-pharyngeal swab Patient hospitalized for COVID-19 in the medical ward, semi-intensive and intensive EXCLUSION CRITERIA Patients younger than 18 years Doubtful or unconfirmed swab detection of SARS-CoV-2

Primary outcomes:
measure: Primary Outcome
timeFrame: Observation during hospitalisation or 30 days after diagnosis
Secondary outcomes:
measure: Secondary Outcome
timeFrame: Observation during hospitalisation or 30 days after diagnosis
measure: Secondary Outcome 2
timeFrame: Observation during hospitalisation or 30 days after diagnosis
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara Arcispedale Sant'Anna
state: Emilia Romagna
Study officials:
affiliation: Università degli Studi di Ferrara
name: Angelina Passaro, MD
role: PRINCIPAL_INVESTIGATOR
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