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Determinants of COVID-19 Pneumonia (MC-19) (MC-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04387799
Recruitment Status : Completed
First Posted : May 14, 2020
Last Update Posted : June 19, 2020
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart

Brief Summary:

Molecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases.

Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal.

Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies.

In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.

Condition or disease Intervention/treatment
Pneumonia, Viral Pneumonia, Bacterial Coronavirus Infection Obstructive Lung Disease Diagnostic Test: Serology for Covid-19

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Study Type : Observational
Actual Enrollment : 520 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Major Determinants of COVID-19 Associated Pneumonia
Actual Study Start Date : May 13, 2020
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Negative PCR Covid associated Pneumonia
Patients with pneumonia who test negative to RT-PCR
Diagnostic Test: Serology for Covid-19
Antibody tests designed to provide results to individuals or healthcare providers can show whether someone was previously infected with SARS-CoV-2 being the RT-PCR negative for the population of patients

Positive PCR Covid associated Pneumonia
Patients with pneumonia from Covid 19

Primary Outcome Measures :
  1. Serology [ Time Frame: 3 weeks ]
    assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.

Secondary Outcome Measures :
  1. Efficacy of CT scan and Serology [ Time Frame: 3 weeks ]
    to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.

  2. Efficacy of different pharmaceutical treatments [ Time Frame: 3 weeks ]
    the efficacy of different pharmaceutical treatments against Covid-19

Biospecimen Retention:   Samples Without DNA
plasma samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects hospitalized for pneumonia who tested negative at RT-PCR

Inclusion Criteria:

  • diagnosis of pneumonia; Covid-19 test negative; hospitalized subjects; both sexes; given informed consent

Exclusion Criteria:

  • age lower than 18 years; pregnancy; breast-feeding

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 identifier (NCT number): NCT04387799

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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
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Principal Investigator: Geltrude Mingrone, MD Fondazione Policlinico Universitario A. Gemelli, IRCCS
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Responsible Party: Geltrude Mingrone, Associate Professor of Internal Medicine, Catholic University of the Sacred Heart Identifier: NCT04387799    
Other Study ID Numbers: 20200505
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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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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Coronavirus Infections
Pneumonia, Viral
Pneumonia, Bacterial
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Bacterial Infections
Bacterial Infections and Mycoses