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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04313946
Other study ID # 0110
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2020
Est. completion date August 18, 2020

Study information

Verified date April 2020
Source Grigore T. Popa University of Medicine and Pharmacy
Contact Alexandru Burlacu, MD, PhD
Phone 0040744488580
Email alexandru.burlacu@umfiasi.ro
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza


Description:

This project aims to use artificial intelligence (image discrimination) algorithms;

- specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19;

- the objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza;

- this software will be trained by introducing X-Rays from patients with/without COVID-19 pneumonitis and/or flu pneumonitis;

- the same AI algorithm will run on future X-Ray scans for predicting possible COVID-19 pneumonitis


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 18, 2020
Est. primary completion date August 16, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- flu-like symptoms: myalgia, cough, fever, sputum

- Chest X-Rays

- COVID-19 biological tests

Exclusion Criteria:

- patient refusal

- uncertain radiographs

- uncertain tests results

Study Design


Intervention

Diagnostic Test:
Scanning Chest X-rays and performing AI algorithms on images
Chest X-Rays; AI CNNs; Results

Locations

Country Name City State
Italy U.O. Multidisciplinare di Patologia Mammaria e Ricerca Traslazionale; Dipartimento Universitario Clinico di Scienze Mediche, Chirurgiche e della Salute Università degli Studi di Trieste Cremona
Romania University of Medicine and Pharmacy Gr T Popa Iasi
United Kingdom Department of Cardiology at Chelsea and Westminster NHS hospital London

Sponsors (3)

Lead Sponsor Collaborator
Professor Adrian Covic Falcon Trading Iasi, Romanian Academy of Medical Sciences

Countries where clinical trial is conducted

Italy,  Romania,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 positive X-Rays Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive 6 months
Primary COVID-19 negative X-Rays Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative 6 months
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