UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045567 |
|---|---|
| Receipt number | R000052017 |
| Scientific Title | Investigation for novel COVID-19 severity factors using human in vitro pathological models and clinical specimens |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2025/03/29 10:31:19 |
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Basic information
Public title
Investigation for novel COVID-19 severity factors using human in vitro pathological models and clinical specimens
Acronym
Investigation for novel COVID-19 severity factors
Scientific Title
Investigation for novel COVID-19 severity factors using human in vitro pathological models and clinical specimens
Scientific Title:Acronym
Investigation for novel COVID-19 severity factors
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate novel predictors of severe disease and immunological mechanisms by combining a SARS-CoV-2 infection model using human iPS cell-derived respiratory and hematopoietic cell systems, alone or in co-culture, with COVID-19 patient sera or blood cell samples.
Basic objectives2
Others
Basic objectives -Others
Immune response to SARS-CoV-2 infection
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
COVID-19 severity factors
Key secondary outcomes
Immune response to SARS-CoV-2 infection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients at 20 year-old or older with COVID-19 diagnosed by PCR methods.
Key exclusion criteria
Minors or patients who cannot give consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
Fushimi-Ku
TEL
0756419161
kfujita.acd@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
NHO Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
Fushimi-Ku
TEL
0756419161
Homepage URL
kfujita.acd@gmail.com
Sponsor or person
Institute
Division of Respiratory Medicine, Center for Respiratory Diseases, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
HiLung Corporation
MiCAN Technologies Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
National Hospital Organization Kyoto Medical Center
IRB Contact (For public release)
Organization
NHO Kyoto Medical Center
Address
Fushimi-Ku
Tel
0756419161
yamaji.hirofumi.bg@mail.hosp.go.jp
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
国立病院機構京都医療センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 01 | Day |
Other
Other related information
Paper being submitted for publication.
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052017
