Imaging Feature of SARS-CoV2 Infection

NCT04394026 | Completed

• 1 other identifier: COVID-19 IF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease.

Conditions

Viral Pneumonia; COVID

Keywords

diagnosis; disease progression; imaging features; SARS-CoV2; COVID

Outcome Measures

Primary Outcomes (4)

• Describe qualitative and quantitative variables

  Evaluate RX imaging aspects at the time of diagnosis and until discharge.

  Through study completion, an average of 5 months

• Describe qualitative and quantitative variables

  Evaluate CT imaging aspects at the time of diagnosis and until discharge.

  Through study completion, an average of 5 months

• Ability of imaging to predict disease progression

  Correlate imaging findings to OS

  Through study completion, an average of 5 months

• Ability of imaging to predict disease evolution

  Correlate imaging findings over time

  Through study completion, an average of 5 months

Secondary Outcomes (2)

• Imaging findings and demographic data

  Through study completion, an average of 5 months

• Imaging findings and laboratory exams

  Through study completion, an average of 5 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proven COVID-19

You may qualify if:

• CoViD-19 positive patients (rRT-PCR naso-pharyngeal swab)
• Suspicion of SARS-CoV2 on chest X-ray and/or chest CT presentation of disease
• Patients of all ages
• Subjects at risk (minors, patients in emergency situations, pregnant women, potentially incapable of giving their consent )
• Having signed the Informed Consent

You may not qualify if:

• Not fulfilling any of the above

Sponsors & Collaborators

• Francesco De Cobelli: lead

Study Sites (1)

Deaprtment of Radiology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pneumonia, Viral; Disease; Disease Progression

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Carlo Martinenghi, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Chair Radiology Department

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: April 16, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

IT (1)