Determinants of COVID-19 Pneumonia (MC-19) (MC-19)
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|ClinicalTrials.gov Identifier: NCT04387799|
Recruitment Status : Completed
First Posted : May 14, 2020
Last Update Posted : June 19, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||520 participants|
|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|
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
- 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.
- 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.
- Efficacy of different pharmaceutical treatments [ Time Frame: 3 weeks ]the efficacy of different pharmaceutical treatments against Covid-19
Biospecimen Retention: Samples Without DNA
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): NCT04387799
|Fondazione Policlinico Universitario A. Gemelli IRCCS|
|Roma, Italy, 00168|
|Principal Investigator:||Geltrude Mingrone, MD||Fondazione Policlinico Universitario A. Gemelli, IRCCS|