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Comparison Between Positive and Negative COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04507893
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Interstitial Pneumonia Other: Clinical, laboratory and imaging characteristics of pneumonia

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical, Laboratory and Imaging Comparison Between COVID-19 Pneumonia Confirmed by PCR Detection on Nasopharyngeal Swab and Negative Swab Pneumonia
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
Hospitalized patients affected by negative COVID-19 interstitial pneumonia (with negative PCR on naso-pharyngeal swab)
 Other: Clinical, laboratory and imaging characteristics of pneumonia
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".


Outcome Measures
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Primary Outcome Measures :
  1. 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". [ Time Frame: 75 Days ]
    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"

  2. 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". [ Time Frame: 75 Days ]
    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".

  3. 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". [ Time Frame: 75 Days ]
    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".


Secondary Outcome Measures :
  1. 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". [ Time Frame: 75 Days ]
    Evaluation of mortality in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.

  2. 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". [ Time Frame: 75 Days ]
    Evaluation of clinical severity in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.

  3. 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". [ Time Frame: 75 Days ]
    Evaluation of hospital stay length in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • age <18 years
  • incomplete medical records with respect to the parameters sought
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507893


Contacts
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Contact: Antonio Carroccio, MD 3395665437 acarroccio@gmail.com

Locations
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Italy
Infectious diseases Unit of the "Cervello-Villa Sofia" Hospital Recruiting
Palermo, PA, Italy, 90146
Contact: Enzo M Farinella, MD    3395665437    acarroccio@hotmail.com   
Internal Medicine Division of the "Cervello-Villa Sofia" Hospital Recruiting
Palermo, PA, Italy, 90146
Contact: Antonio Carroccio, MD    +390916552884    acarroccio@hotmail.com   
Pulmonology Unit Dedicated to COVID-19 Patients Recruiting
Palermo, PA, Italy, 90146
Contact: Giuseppe Arcoleo, MD    3385665437    acarroccio@gmail.com   
Sponsors and Collaborators
University of Palermo
Investigators
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Principal Investigator: Antonio Carroccio, MD University of Palermo
More Information
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Responsible Party: Pasquale Mansueto, Clinical Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT04507893    
Other Study ID Numbers: ACPM26
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections