Pneumonia Clinical Trial
Official title:
Low-dose Computed Tomography in COVID-19 Pneumonia: a Prospective Moscow Study
Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of
pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled
in the study.
Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during
one visit to the computed tomography room.
As of 30 April 2020, there were over 3 million confirmed cases worldwide, of which over
200,000 were fatal. In Russia at the time of writing, 106 thousand cases of COVID-19 were
registered in 78 regions, with 11619 recovered and 1073 dead. Initial prospective analysis of
clinical data from 41 patients in Wuhan, with laboratory confirmation of the 2019-nCoV-2
virus, showed that 2019-nCoV-2 caused severe illness, clinically similar to SARS, which
sometimes led to the need for hospitalization in the intensive care unit (13 out of 41 [32
%]) and death (6 out of 41 [15%]). All patients with pneumonia in this study had changes in
the chest CT scan: preliminary reports indicated that all patients had bilateral lung
infiltration.
Given the current prevalence of the disease and the nonspecific symptoms, we expect a
significant increase in chest CT scans shortly. A low-dose chest CT scan can be performed
with an effective dose of no more than 3.5 mSv, which is much lower than the dose received
with a standard protocol - 8-10 mSv.
The investigators hypothesize that a patient with suspected pneumonia can have a low-dose
chest CT scan instead of a standard CT while maintaining the accuracy of the method in the
diagnosis of inflammatory pulmonary tissue infiltration. The advantage of participating in
the study for the patient is the possibility of obtaining an image without motion artifacts
that may be associated with coughing, possibly affecting the patient's management tactics.
The study is intended to provide answers to the following questions:
The primary point of the study is to evaluate the correlation between standard CT and
low-dose CT scans for the detection of community-acquired pneumonia. The expected correlation
percentage is 90%.
The secondary point of study No. 1 is the threshold value of the infiltration zone size
detected by low-dose CT scan compared to standard CT scan. Expected threshold - 10 mm.
The secondary point of study No.2 is the number of infiltration zones of pulmonary parenchyma
corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT
scan. Expected number - more than two zones.
In the future, it is planned to use the obtained anonymized data to enter the international
registers of images of pneumonia caused by COVID-19.
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