臨床研究等提出・公開システム

Date of registration	Sept. 22, 2021
Last modified on	Sept. 22, 2021
Trial ID	jRCT1050210089

Scientific Title	COVID Triage Machine Learning Algorithm Using CT Images Multicenter Observational Study (AICOVID study)
Public Title	COVID Triage AI Algorithm Using CT Images (AICOVID study)

Contact for Scientific Queries	Name	Okada Naoki
	Affiliation	Osaka General Medical Center
	Address	3-1-56,Bandaihigashi,Sumiyoshi,Osaka
	Telephone	+81-6-6692-1201
	E-mail	wggdilp@gmail.com
Contact for Public Queries	Name	Okada Naoki
	Affiliation	Osaka General Medical Center
	Address	3-1-56,Bandaihigashi,Sumiyoshi,Osaka
	Telephone	+81-6-6692-1201
	E-mail	wggdilp@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 07, 2020
Actual date of first enrollment		Oct. 07, 2020
Target sample size		3000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Three groups of patients will be included in the study: patients with COVID and patients with pneumonia due to other infectious diseases who visited the Emergency Department or were admitted to the Emergency Department of the Osaka General Medical Center, and patients who had a chest CT scan as a screening (e.g., trauma patients with a normal chest CT image as a result). Patients at other participating centers will be selected according to the above criteria.
	Exclusion Criteria	(1) Patients who have refused to use the information after reading the information disclosure document (2) Patients for whom the scope of imaging was inappropriate (3) Patients with other data deficiencies (4) Patients deemed inappropriate by the researcher.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19,SARS-CoV-2
Health Condition(s) Keyword		COVID-19,SARS-CoV-2
Primary Outcome(s)		Predictive ability of a machine learning model that automatically analyzes laboratory images of COVID patients for COVID infection Comparison with the ability of emergency department physicians to predict COVID infection
Secondary Outcome(s)		Comparison of predictive ability in disease severity

Primary Sponsor	Osaka General Medical Center

Secondary Sponsor

Source of Monetary Support	Mitsubishi Research Institute, Inc.
Secondary Sponsor	Applicable

Name of Certified Review Board	Osaka General Medical Center Clinical medicine Ethics Committee
Address	3-1-56,Bandaihigashi,Sumiyoshi,Osaka, Osaka
Telephone	+81-6-6692-1201
E-Mail	kenkyu-crb@gh.opho.jp
Approval Status	Approval
Date of approval	Oct. 07, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none