Independent Predictors on Clinical Outcomes in SARS-CoV2 Patients

Completed

• Conditions: COVID-19 Patients
• Interventions: Other: effect of COVID-19 exposure

• Registration Number: NCT05162534
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2020-05-29
• Primary Completion: 2020-09-30
• Study Completion: 2021-07-22
• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30-day survived patients	effect of COVID-19 exposure	Patient survived after a period of observation of 30 days are presented with the acronyms "30-dsp" (30-day survived patients)
Patients needing IoC	effect of COVID-19 exposure	Patients needing IoC can be recognized by the acronym "IoCp"
30-day deceased patients	effect of COVID-19 exposure	Patient died after a period of observation of 30 days are presented with the acronyms "30-ddp" (30-day deceased patients)
did not undergo IoC	effect of COVID-19 exposure	Patients did not undergo IoC, we chose the acronym "nIoCp".

Primary Outcome Measures

Name	Time	Method
Primary Outcome	Observation during hospitalisation or 30 days after diagnosis	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 Outcome Measures

Name	Time	Method
Secondary Outcome 2	Observation during hospitalisation or 30 days after diagnosis	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.
Secondary Outcome	Observation during hospitalisation or 30 days after diagnosis	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

Trial Locations

Locations (1)

University Hospital of Ferrara Arcispedale Sant'Anna; 🇮🇹 Ferrara, Emilia Romagna, Italy