Independent Predictors on Clinical Outcomes in SARS-CoV2 Patients (outcomes)

December 9, 2021 updated by: Angelina Passaro, University Hospital of Ferrara

Evaluation of Independent Clinical- Laboratory Predictors of Clinical Outcomes in Hospitalized Positive SARS-CoV2 Patients (Outcomes SARS-CoV2)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia Romagna
      • Ferrara, Emilia Romagna, Italy, 44124
        • University Hospital of Ferrara Arcispedale Sant'Anna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 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
Observation during hospitalisation or 30 days after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 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
Observation during hospitalisation or 30 days after diagnosis
Secondary Outcome 2
Time Frame: 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.
Observation during hospitalisation or 30 days after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Collaborators

Università degli Studi di Ferrara

Investigators

  • Principal Investigator: Angelina Passaro, MD, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

July 22, 2021

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 520/2020/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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