MSCT Chest in Suspected COVID-19 Patients

NCT04492865 | Unknown DMC

• 1 other identifier: CTCOV
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to evaluate the accuracy of MSCT chest in the detection of COVID-19 cases and to correlate its diagnostic performance with that of the clinical presentation and CBC indices; using RT-PCR assays as a gold standard.

Conditions

COVID-19

Keywords

MSCT; RT-PCR

Outcome Measures

Primary Outcomes (1)

• Accuracy of non contrast MSCT chest in COVID-19

  Correlation of its diagnostic performance with clinical presentation and CBC indices; using RT-PCR assays as a gold standard.

  baseline

Secondary Outcomes (1)

• MSCT chest can be used as an alternative diagnostic tool for COVID-19 cases.

  baseline

Interventions

MSCT DEVICE

-Laboratory tests: All routine indicators of CBC are evaluated * Nasopharyngeal and oropharyngeal swabs are obtained from each patient to confirm the positivity to Covid-19 by performing RT-PCR to detect the viral RNA. * MSCT Chest images of all patients are evaluated by three radiologists with variable experiences in CT chest interpretation. The readers are blinded of the RT-PCR results and the CBC indices of the patients and they have access only to the epidemiological history, clinical symptoms, and signs. By consensus, the radiologists score the chest CT as positive or negative for COVID-19 viral pneumonia. When the chest CT is classified as positive, the main CT features are recorded as present or absent (ground-glass opacity, crazy paving, consolidation, nodules, air bronchogram, air trapping, halo sign, reversed halo sign, bronchial wall abnormalities, vascular enlargement, pleural effusion, and lymphadenopathy.

Also known as: RT-PCR

Eligibility Criteria

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

Study Population

A prospective single-center cohort study includes all patients ≥18 years of both sex attended to the emergency unit of Assiut University Hospital with a clinical suspicion of COVID-19 infection.

You may qualify if:

• patients presented by fever, myalgia or respiratory symptoms
• Close contact with a confirmed COVID-19 patient

You may not qualify if:

• pediatric patients
• patients refuse any of the following: MSCT chest, taking of nasopharyngeal swabs or blood sample
• chest MSCT -Angiography was done for suspected vascular complications (e.g., pulmonary embolism)
• severely dyspneic patients with motion artifact on MSCT images.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (1)

• 1. Masters PS. Coronavirus genomic RNA packaging. Virology. 2019;537:198-207. doi:10.1016/j.virol.2019.08.031 2. Shi Z, Hu Z. A review of studies on animal reservoirs of the SARS coronavirus. Virus Res. 2008;133(1):74-87. doi:10.1016/j.virusres.2007.03.012 3. Donnelly CA, Ghani AC, Leung GM, et al. Epidemiological determinants of spread of causal agent of severe acute respiratory syndrome in Hong Kong [published correction appears in Lancet. 2003 May 24;361(9371):1832]. Lancet. 2003;361(9371):1761-1766. doi:10.1016/S0140-6736(03)13410-1 4. Cauchemez S, Fraser C, Van Kerkhove MD, et al. Middle East respiratory syndrome coronavirus: quantification of the extent of the epidemic, surveillance biases, and transmissibility. Lancet Infect Dis. 2014;14(1):50-56. doi:10.1016/S1473-3099(13)70304-9

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Abeer Ali, M D

  Assiut University

  PRINCIPAL INVESTIGATOR

• Sara Hassanin, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Marwa Khairallah, M D

  Assiut University

  PRINCIPAL INVESTIGATOR

• Dalia Kamal, M D

  Assiut University

  PRINCIPAL INVESTIGATOR

• Walaa Ali, M D

  Assiut University

  PRINCIPAL INVESTIGATOR

• Salwa Seif Eldein, PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gehan S Seifeldein, M.D.

CONTACT

+201224417605; gehanseifeldein@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of diagnostic radiology

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 30, 2020
• Study Start: July 30, 2020
• Primary Completion: August 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

EG (1)