UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043622 |
|---|---|
| Receipt number | R000049811 |
| Scientific Title | Retrospective cohort study utilizing COVIREGI-JP to evaluate the efficacy of tocilizumab for severe COVID-19 pneumonia |
| Date of disclosure of the study information | 2021/03/16 |
| Last modified on | 2024/09/17 10:24:41 |
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Basic information
Public title
Retrospective cohort study utilizing COVIREGI-JP to evaluate the efficacy of tocilizumab for severe COVID-19 pneumonia
Acronym
SL43051
Scientific Title
Retrospective cohort study utilizing COVIREGI-JP to evaluate the efficacy of tocilizumab for severe COVID-19 pneumonia
Scientific Title:Acronym
SL43051
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tocilizumab, administered to patients with severe COVID-19 pneumonia and were enrolled in JA42434 study against SOC population, by generating a synthetic control group from the SOC population in the COVIREGI-JP cohort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time until discharge or waiting for discharge (with normal body temperature and respiratory rate, stable oxygen saturation under ambient air or oxygenation of 2 L or less)
Key secondary outcomes
7-point scale clinical categorization
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Tocilizumab population in JA42434 study]
1)Patients administered with Tocilizumab in JA42434 study
[COVIREGI-JP Cohort]
1)Aged 18 years or older at the onset of COVID-19
2)Hospitalized between May 11, 2020 to Nov 18, 2020
Key exclusion criteria
[COVIREGI-JP cohort]
1)Pregnant women
2)Patients administered with any of the below during hospitalization
- Sarilumab
- Baricitinib
Target sample size
248
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ohmagari |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
03-3202-7181
registry.covid@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Matsunaga |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
03-3202-7181
Homepage URL
registry.covid@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical 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
National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku, Tokyo
Tel
03-3202-7181
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
| 2021 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
confirming
Publication of results
Partially published
Result
URL related to results and publications
confirming
Number of participants that the trial has enrolled
16898
Results
1. Start of patient registration: May 11, 2021
2. Number of registration: 16898
3. Initially planned number of registration: 10000
Results date posted
| 2024 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who meet all of the following criteria will be included in this study
1) Tocilizumab population of the JA42434 study
-Patients who received tocilizumab in the JA42434 study
2) COVIREGI-JP cohort only
-COVID-19 Patients aged 18 years or older at onset of disease
-Patients admitted between May 11, 2020 and November 28, 2020
Participant flow
This is a retrospective cohort study and will use information from the JA42434 study and the COVIREGI-JP registry.
Adverse events
None
Outcome measures
Time until discharge or waiting for discharge (with normal body temperature and respiratory rate, stable oxygen saturation under ambient air or oxygenation of 2 L or less)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049811
