NCT04507893

Comparison Between Positive and Negative COVID-19 Pneumonia

Completed Last updated 18 May 2022

What this trial tests

trial testing Clinical, laboratory and imaging characteristics of pneumonia in Covid19 in 80 participants. Completed in 1 April 2022.

Timeline

15 March 2020

Primary endpoint
30 September 2020

1 April 2022

Quick facts

Lead sponsor	University of Palermo
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	15 March 2020
Primary completion	30 September 2020
Estimated completion	1 April 2022
Sites	3 locations across Italy

Drugs / interventions tested

• Clinical, laboratory and imaging characteristics of pneumonia

Conditions studied

• Covid19 — all drugs for Covid19 →
• Interstitial Pneumonia — all drugs for Interstitial Pneumonia →

Sponsor

University of Palermo

Who can join

Adults 18 to 95, any sex, with Covid19 or Interstitial Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. COVID-19 and non-COVID-19 pneumonia: a comparison.
   Di Mitri C, Arcoleo G, Mazzuca E, Camarda G, et al · · 2021 · cited 11× · PMID 34854790 · DOI 10.1080/07853890.2021.2010797