LDCT in COVID-19 Pneumonia: a Prospective Moscow Study

NCT04379531 | Completed

• 1 other identifier: 2020-1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Coronavirus Infection

Keywords

Low-dose CT; Community-acquired pneumonia; Computed tomography

Outcome Measures

Primary Outcomes (1)

• Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia.

  A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.

  Upon completion, up to 1 year

Secondary Outcomes (2)

• Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan.

  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.

  Upon completion, up to 1 year

Study Arms (2)

Standard Chest CT

ACTIVE COMPARATOR

Diagnostic Test: Low-dose Chest CT

Low-dose Chest CT

EXPERIMENTAL

Diagnostic Test: Low-dose Chest CT

Interventions

Low-dose Chest CT DIAGNOSTIC_TEST

Patients referred by the primary care physician with suspected pneumonia.

Low-dose Chest CT; Standard Chest CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Victor Gombolevskiy

Moscow, 109029, Russia

Location

Related Publications (1)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Coronavirus Infections; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Community-Acquired Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Research Officer

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 7, 2020
• Study Start: April 25, 2020
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)