UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051337 |
|---|---|
| Receipt number | R000058543 |
| Scientific Title | Development of new endpoints and analysis methods for clinical trials in COVID-19 patients |
| Date of disclosure of the study information | 2023/06/14 |
| Last modified on | 2023/06/14 10:28:53 |
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Basic information
Public title
Development of new endpoints and analysis methods for clinical trials in COVID-19 patients
Acronym
Development of new endpoints and analysis methods for clinical trials in COVID-19 patients
Scientific Title
Development of new endpoints and analysis methods for clinical trials in COVID-19 patients
Scientific Title:Acronym
Development of new endpoints and analysis methods for clinical trials in COVID-19 patients
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop new endpoints and analysis methods for use in clinical trials in COVID-19 patients using data from the Adaptive Covid-19 Treatment Trial ("ACTT-1") in COVID-19 patients.
Basic objectives2
Others
Basic objectives -Others
To evaluate the performance of the newly proposed evaluation items and analysis method through simulation experiments and apply them to ACTT-1 data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to death
Time to improvement
Daily symptoms during the study period (7-category ordinal scale data)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 enrolled and randomized in the ACTT-1 trial
Key exclusion criteria
Patients enrolled and randomized in the ACTT-1 trial
Target sample size
1063
Research contact person
Name of lead principal investigator
| 1st name | YUKARI |
| Middle name | YUKARI |
| Last name | UEMURA |
Organization
National Center for Global Health and Medicine
Division name
Center for Clinical Research
Zip code
162-8655
Address
Tokyo-to Shinjyuku-ku Toyama 1-21-1
TEL
0332027181
yuemura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | YUKARI |
| Middle name | YUKARI |
| Last name | UEMURA |
Organization
National Center for Global Health and Medicine
Division name
Center for Clinical Research
Zip code
162-8655
Address
Tokyo-to Shinjyuku-ku Toyama 1-21-1
TEL
0332027181
Homepage URL
yuemura@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nationa Center for Global Health and Medicine
Address
Tokyo-to Shinjyuku-ku Toyama 1-21-1
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 14 | 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
1063
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
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is a secondary use of RCT data and involves statistical methods.
Management information
Registered date
| 2023 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058543
