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Completed

NCT Number: NCT05162534

Independent Predictors on Clinical Outcomes in SARS-CoV2 Patients

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

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Key information

Conditions

COVID-19 Patients COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ferrara Arcispedale Sant'Anna

Ferrara, Emilia-Romagna, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

effect of COVID-19 exposure

Other

effect of COVID-19 exposure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Università degli Studi di Ferrara

Registry information

Official study title

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

Acronym: outcomes

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2021
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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