Determinants of COVID-19 Pneumonia (MC-19)

NCT04387799 | Completed

• 1 other identifier: 20200505
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Viral; Pneumonia, Bacterial; Coronavirus Infection; Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• Serology

  assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.

  3 weeks

Secondary Outcomes (2)

• Efficacy of CT scan and Serology

  3 weeks

• Efficacy of different pharmaceutical treatments

  3 weeks

Study Arms (2)

Negative PCR Covid associated Pneumonia

Patients with pneumonia who test negative to RT-PCR

Diagnostic Test: Serology for Covid-19

Positive PCR Covid associated Pneumonia

Patients with pneumonia from Covid 19

Interventions

Serology for Covid-19 DIAGNOSTIC_TEST

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

Negative PCR Covid associated Pneumonia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects hospitalized for pneumonia who tested negative at RT-PCR

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (5)

• Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1070-1076. doi: 10.1515/cclm-2020-0285.

  PMID: 32172228 BACKGROUND

• Lippi G, Plebani M, Graber ML. Building a bridge to safe diagnosis in health care. The role of the clinical laboratory. Clin Chem Lab Med. 2016 Jan;54(1):1-3. doi: 10.1515/cclm-2015-1135. No abstract available.

  PMID: 26630697 BACKGROUND

• Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.

  PMID: 32101510 BACKGROUND

• Xie X, Zhong Z, Zhao W, Zheng C, Wang F, Liu J. Chest CT for Typical Coronavirus Disease 2019 (COVID-19) Pneumonia: Relationship to Negative RT-PCR Testing. Radiology. 2020 Aug;296(2):E41-E45. doi: 10.1148/radiol.2020200343. Epub 2020 Feb 12.

  PMID: 32049601 BACKGROUND

• Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

  PMID: 31986261 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

Pneumonia, Viral; Pneumonia, Bacterial; Coronavirus Infections; Lung Diseases, Obstructive

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Officials

• Geltrude Mingrone, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 14, 2020
• Study Start: May 13, 2020
• Primary Completion: June 12, 2020
• Study Completion: June 17, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

IT (1)