Comparison Between Positive and Negative COVID-19 Pneumonia

NCT04507893 | Completed

• 1 other identifier: ACPM26
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.

Conditions

Covid19; Interstitial Pneumonia

Outcome Measures

Primary Outcomes (3)

• Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  Accuracy of severity of respiratory insufficiency - evaluated as need of three step "nasal oxygen, oxygen mask, invasive ventilation" - in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls"

  75 Days

• Evaluation of the laboratory characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  Accuracy of the association of 3 haemato-chemical abnormalities (lymphopenia + increased serum transaminases + increased serum LDH) in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".

  75 Days

• Evaluation of the imaging characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  Accuracy of thorax CT scan in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".

  75 Days

Secondary Outcomes (3)

• Evaluation of mortality of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  75 Days

• Evaluation of clinical severity of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  75 Days

• Evaluation of hospital stay length of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".

  75 Days

Study Arms (2)

SARS-COV-2 PNEUMONIA CONFIRMED BY PCR ON NASOPHARYNGEAL SWAB

Hospitalized patients affected by COVID-19 interstitial pneumonia (with positive PCR on naso-pharyngeal swab)

Other: Clinical, laboratory and imaging characteristics of pneumonia

NEGATIVE SARS-COV-2 PNEUMONIA

Hospitalized patients affected by negative COVID-19 interstitial pneumonia (with negative PCR on naso-pharyngeal swab)

Other: Clinical, laboratory and imaging characteristics of pneumonia

Interventions

Clinical, laboratory and imaging characteristics of pneumonia OTHER

Evaluation of the clinical, laboratory and imaging characteristics in patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "negative COVID-19 patients".

NEGATIVE SARS-COV-2 PNEUMONIA; SARS-COV-2 PNEUMONIA CONFIRMED BY PCR ON NASOPHARYNGEAL SWAB

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective, multicenter study, conducted on patients with interstitial pneumonia, admitted, consecutively, to the Internal Medicine I Unit of the "Villa Sofia - Cervello" Hospitals of Palermo, and two other Units dedicated to Patients affected with COVID-19, in the same hospital, from March 15, 2020 to May 31, 2020.

You may qualify if:

• All consecutive patients referred to the Emergency Unit of the "V. Cervello" Hospital, in Palermo, Italy, for clinical symptoms suggestive of suspected COVID-19 infection.
• In details, we consider patients referred for one or more of the following manifestations: respiratory symptoms, fever, taste or smell loss.
• To be included their records must include:
• detailed clinical history
• radiological findings (High-resolution CT, HRCT)
• results of viral RNA research for SARS-COV2, by PCR on nasopharyngeal swab, repeated two times (at the admission and again after 48 hours from the admission in the Emergency Unit)
• laboratory results regarding routine hemato-chemical assays
• oxygen therapy
• treatment used.

You may not qualify if:

• age \<18 years
• incomplete medical records with respect to the parameters sought

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (3)

Infectious diseases Unit of the "Cervello-Villa Sofia" Hospital

Palermo, PA, 90146, Italy

Location

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, 90146, Italy

Location

Pulmonology Unit Dedicated to COVID-19 Patients

Palermo, PA, 90146, Italy

Location

Related Publications (1)

• Di Mitri C, Arcoleo G, Mazzuca E, Camarda G, Farinella EM, Soresi M, Carroccio A; IMUSG. COVID-19 and non-COVID-19 pneumonia: a comparison. Ann Med. 2021 Dec;53(1):2321-2331. doi: 10.1080/07853890.2021.2010797.

  PMID: 34854790 DERIVED

MeSH Terms

Conditions

COVID-19; Lung Diseases, Interstitial

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Antonio Carroccio, MD

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: March 15, 2020
• Primary Completion: September 30, 2020
• Study Completion: April 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)