UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052949
Receipt number R000060353
Scientific Title Assessment of the Relationship between Symptoms and Ct Values in Influenza Virus Infection, and Evaluation of Symptoms Over Time
Date of disclosure of the study information 2023/12/01
Last modified on 2023/11/28 09:07:05

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Basic information

Public title

Assessment of the Relationship between Symptoms and Ct Values in Influenza Virus Infection, and Evaluation of Symptoms Over Time

Acronym

Assessment of the Relationship between Symptoms and Ct Values in Influenza Virus Infection, and Evaluation of Symptoms Over Time

Scientific Title

Assessment of the Relationship between Symptoms and Ct Values in Influenza Virus Infection, and Evaluation of Symptoms Over Time

Scientific Title:Acronym

Assessment of the Relationship between Symptoms and Ct Values in Influenza Virus Infection, and Evaluation of Symptoms Over Time

Region

Japan


Condition

Condition

Influenza infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective is to evaluate the relationship between influenza symptoms and findings, as well as Ct values, based on data from influenza patients. Additionally, the study aims to assess the relationship between the timing of medical visits and various symptoms. Furthermore, it seeks to evaluate the association between influenza vaccination status, medical history, and the use of medication.

Basic objectives2

Others

Basic objectives -Others

The objective is to evaluate the relationship between influenza symptoms and findings, as well as Ct values, based on data from influenza patients. Additionally, the study aims to assess the relationship between the timing of medical visits and various symptoms. Furthermore, it seeks to evaluate the association between influenza vaccination status, medical history, and the use of medication.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary endpoint:
(1) Relationship between body temperature and Ct value at the time of visit

Key secondary outcomes

Secondary endpoints
(2) Relationship between the presence or absence of subjective symptoms at the time of visit and Ct value
(3) Relationship between the number of subjective symptoms at the time of visit and Ct value
Exploratory evaluation items
(4) Relationship between time from onset of symptoms to hospital visit and subjective symptoms at hospital visit
(5) Relationship between Ct value at visit and vaccination history
(6) Relationship between body temperature at the time of visit and vaccination history


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

6 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Among the patients registered in the Influenza Follicle Data Collection Research, we have been able to obtain information on the following
Patient characteristics
Physical findings, subjective symptoms
Clinical test information
2.Those determined to be influenza positive by PCR method

Key exclusion criteria

Cases in which information regarding patient characteristics, physical findings, subjective symptoms, and clinical test information cannot be obtained.

Target sample size

4194


Research contact person

Name of lead principal investigator

1st name Memori
Middle name
Last name Fukuda

Organization

Aillis, Inc.

Division name

Research & Collaboration

Zip code

104-0028

Address

7th Floor, Yaesu Central Tower, 2-2-1 Yaesu, Chuo-ku, Tokyo, Japan.

TEL

03-5218-2374

Email

memori.fukuda@aillis.jp


Public contact

Name of contact person

1st name Memori
Middle name
Last name Fukuda

Organization

Aillis, Inc.

Division name

Research & Collaboration

Zip code

104-0028

Address

7th Floor, Yaesu Central Tower, 2-2-1 Yaesu, Chuo-ku, Tokyo, Japan.

TEL

03-5218-2374

Homepage URL


Email

memori.fukuda@aillis.jp


Sponsor or person

Institute

Aillis, Inc.

Institute

Department

Personal name



Funding Source

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

20-9-401,Mita 5-chome, Minato-ku, Tokyo

Tel

03-6416-1868

Email

npo-mins@j-irb.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

4194

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2023 Year 10 Month 13 Day

Date of IRB

2023 Year 11 Month 09 Day

Anticipated trial start date

2023 Year 11 Month 09 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2023 Year 11 Month 29 Day

Last modified on

2023 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060353