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

June 10, 2020 updated by: Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Upon completion, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon completion, up to 1 year
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.
Upon completion, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2020

Primary Completion (Actual)

May 22, 2020

Study Completion (Actual)

May 22, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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