Comparison Between Positive and Negative COVID-19 Pneumonia
Condition: Covid19; Interstitial Pneumonia
MeSH terms: COVID-19; Pneumonia; Lung Diseases, Interstitial
Study type: Observational

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.
    

Detailed description: 
      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.
      Multisystem involvement and hyperinflammatory organ and systemic response are responsible for
      the patient's death. Overall, hospital mortality from COVID-19 is approximately 15% to 20%,
      but up to 40% among patients requiring ICU admission. The diagnosis of SARS-COV-2 infection
      is made by direct detection of viral RNA on different biological materials from patients with
      suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal
      swab; molecular investigations can also be carried out on samples from the distal respiratory
      tract (BronchoAlveolar Lavage, BAL). 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 sensitivity data available are around 40-70%.
      The result is the possibility of a consistent series of false negatives (at least one third),
      represented by patients which have clinical characteristics compatible with SARS-COV-2
      infection, but resulted, however, negative to the nasopharyngeal swab. These cases are framed
      as COVID-19-like cases and constitute a serious problem for the risk of not to recognize
      hospitalized patients suffering from COVID-19 infection.

      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.
      The cases studied will be represented by patients hospitalized for interstitial pneumonia in
      the participating hospital centers in the period between mid-March 2020 and end of May 2020.
      For these cases, all available data contained in the medical records of patients, enrolled
      within the time frame indicated above, will be retrospectively analyzed. Due to relative lack
      of sensitivity of COVID-19 PCR assay in nasopharyngeal swab, patients affected with COVID-19
      infection can be mixed with other hospitalized patients and with unprotected health staff. On
      the basis of the comparison of the clinical, laboratory and imaging data the study would
      identify the characteristics which can differentiate patients with SARS-COV-2 pneumonia,
      confirmed by nasopharyngeal swab, and interstitial pneumonia and negative COVID-19 PCR on
      swab. The investigators aim to highlight any similarities or differences or the need for
      differentiated treatments.
    

Intervention name(s): Clinical, laboratory and imaging characteristics of pneumonia
Intervention type(s): Other
Intervention description(s): 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".
Observational model: Case-Only
Time perspective: Retrospective
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.