UMIN-ICDS Clinical Trial

Public title

Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19

Acronym

Data collection clinical studies, regarding influenza or COVID-19

Scientific Title

Data collection clinical studies, including pharyngeal imaging, in patients with seasonal influenza or COVID-19

Scientific Title:Acronym

Data collection clinical studies, regarding influenza or COVID-19

Region

Japan

Condition

Seasonal influenza
COVID-19

Classification by specialty

Medicine in general	Pneumology	Infectious disease
Pediatrics	Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Collect pharyngeal images and clinical information from patients suspected of having influenza or COVID-19 and create a dataset for use in development, etc. (including performance evaluation tests in applications for regulatory approval), including performance improvement of medical devices using artificial intelligence for the diagnosis of influenza or COVID-19, etc.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

-

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

4

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who present to the outpatient clinic of the Principal Investigator or Co-Investigator (excluding Aillis, Inc.) with complaints of fever and airway symptoms and who fulfil all of the following 1), 2), 3) and 4) will be included in the study. If the patient is seen again with similar symptoms during the study period, he/she may be enrolled in the study again.
1) Persons who have undergone antigen qualitative testing for influenza and novel coronavirus with suspected influenza or COVID-19.
2) Persons aged 4 years or older at the time consent is obtained
3) Persons who have obtained the free written consent of the individual or a surrogate to participate in this study
4) Persons who fall under one or more of the following items from (1) to (4) (however, for items (1) to (3), only persons within 48 hours of the onset of symptoms are counted under the relevant item)
(i) Fever of 37.0 C or more (including cases where the temperature exceeded 37 C measured at home, etc.)
(ii) With systemic symptoms such as arthralgia, myalgia, headache, or general malaise, anorexia, etc.
(iii) Respiratory symptoms with cough, sore throat or nasal discharge/nasal obstruction
(iv) Suspected of having influenza or COVID-19 according to a doctor's judgement, such as through concentrated contact with a patient who has influenza or COVID-19

Key exclusion criteria

1) Persons with impaired consciousness or breathing disorders (respiratory failure)
2) Persons with moderate or severe gingival or dental disease or upset teeth that may be aggravated by the use of the research equipment
3) Persons with trauma or damage to the maxillofacial, dental, oral or pharyngeal regions that may be aggravated by the use of the research equipment, or who have undergone surgery on these parts within one month
4) Persons who repeatedly vomit.
5) Other persons who are judged by the principal investigator or research assistant to be unsuitable as subjects for the study

Target sample size

4600

Name of lead principal investigator

1st name	Tsukasa
Middle name
Last name	Nakadai

Organization

Medical Corporation, Shoseikai, Fukuda Internal Medicine

Division name

-

Zip code

335-0015

Address

2-7-30, Kawagishi, Toda-shi, Saitama

TEL

048-431-3737

Email

fukudanaika8915@gmail.com

Name of contact person

1st name	Memori
Middle name
Last name	Fukuda

Organization

Aillis,Inc.

Division name

-

Zip code

104-0028

Address

Yaesu Central Tower 7F, 2-2-1 Yaesu, Chuo-ku, Tokyo 104-0028, Japan

TEL

03-5218-2374

Homepage URL

Email

clinicalresearch_flucov2023_01@aillis.jp

Institute

Medical Corporation, Shoseikai, Fukuda Internal Medicine

Institute

Department

Personal name

Organization

Aillis,Inc.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nihonbashi Sakura Clinic

Address

Toranomon 36 Mori Building 7F, 3-4-7 Toranomon, Minato-ku, Tokyo-to 105-0001 Japan

Tel

03-6777-1490

Email

c-irb_ug@neues.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

22

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data collection clinical studies, including pharyngeal imaging

Registered date

2023

Year

11

Month

24

Day

Last modified on

2023

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060354