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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043622
Receipt No. 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 2021/09/15

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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
Email 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
Email registry.covid@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 14 Day
Date of IRB
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
2021 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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