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LDCT in COVID-19 Pneumonia: a Prospective Moscow Study (LDCTiP)

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.
 
ClinicalTrials.gov Identifier: NCT04379531
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pneumonia Coronavirus Infection Diagnostic Test: Low-dose Chest CT Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Low-dose Computed Tomography in COVID-19 Pneumonia: a Prospective Moscow Study
Actual Study Start Date : April 25, 2020
Actual Primary Completion Date : May 22, 2020
Actual Study Completion Date : May 22, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Chest CT Diagnostic Test: Low-dose Chest CT
Patients referred by the primary care physician with suspected pneumonia.
Experimental: Low-dose Chest CT Diagnostic Test: Low-dose Chest CT
Patients referred by the primary care physician with suspected pneumonia.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. [ Time Frame: Upon completion, up to 1 year ]
    A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.


Secondary Outcome Measures :
  1. Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan. [ Time Frame: Upon completion, up to 1 year ]
    Expected threshold - 10 mm.

  2. Number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan. [ Time Frame: Upon completion, up to 1 year ]
    Expected number - more than two zones.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A referral from the attending physician for a chest CT scan
  • Suspected pneumonia
  • Signed informed consent
  • Over 18 years old
  • Both male and female

Exclusion Criteria:

  • Pregnant or nursing women
  • Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
  • Patients after surgical intervention at the level of the chest organs
  • Cancer patients
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04379531


Locations
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Russian Federation
Victor Gombolevskiy
Moscow, Russian Federation, 109029
Sponsors and Collaborators
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
More Information
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Publications:

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Responsible Party: Sergey Morozov, Chief Research Officer, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
ClinicalTrials.gov Identifier: NCT04379531    
Other Study ID Numbers: 2020-1
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department:
Low-dose CT
Community-acquired pneumonia
Computed tomography
Additional relevant MeSH terms:
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Pneumonia
Coronavirus Infections
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases