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 | 2026/06/15 10:50:51 |
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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
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
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060353
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060353
Number of participants that the trial has enrolled
3979
Results
This study demonstrated a statistically significant association between viral load (assessed by Ct value) and body temperature in patients with influenza A. The finding that body temperature decreased by 0.031 degree Celsius for each one-unit increase in Ct value suggests that higher viral loads are associated with greater degrees of fever.
Results date posted
| 2026 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 06 | Month | 15 | Day |
Baseline Characteristics
The number of patients who tested positive for influenza A and negative for influenza B was 3,979.
Participant flow
This study was a secondary use of data collected in a preceding influenza cohort study, and participants from the prior study were enrolled after providing consent for secondary data use and sharing with third parties.
Adverse events
Not an evaluation endpoint.
Outcome measures
Relationship between body temperature and Ct value at the time of visit
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 04 | Month | 07 | Day |
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060353
