Coronavirus Infection Clinical Trial
— MC-19Official title:
Major Determinants of COVID-19 Associated Pneumonia
NCT number | NCT04387799 |
Other study ID # | 20200505 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 13, 2020 |
Est. completion date | June 17, 2020 |
Verified date | June 2020 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 520 |
Est. completion date | June 17, 2020 |
Est. primary completion date | June 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
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 in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Feb 26:200642. doi: 10.1148/radiol.2020200642. [Epub ahead of print] — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Xie X, Zhong Z, Zhao W, Zheng C, Wang F, Liu J. Chest CT for Typical 2019-nCoV Pneumonia: Relationship to Negative RT-PCR Testing. Radiology. 2020 Feb 12:200343. doi: 10.1148/radiol.2020200343. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Efficacy of CT scan and Serology | 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. | 3 weeks | |
Secondary | Efficacy of different pharmaceutical treatments | the efficacy of different pharmaceutical treatments against Covid-19 | 3 weeks |
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