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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040614
Receipt No. R000046354
Scientific Title A retrospective study on the therapeutic effect of tocilizumab on COVID-19
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/01

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Basic information
Public title A retrospective study on the therapeutic effect of tocilizumab on COVID-19
Acronym J-COVID-RT
Scientific Title A retrospective study on the therapeutic effect of tocilizumab on COVID-19
Scientific Title:Acronym J-COVID-RT
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Medicine in general Pneumology Infectious disease
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the therapeutic effect of tocilizumab on the cytokine storm caused by COVID-19
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival rate
Key secondary outcomes 1) Time until the RT-PCR becomes negative in the pharyngeal swab or nasopharyngeal swab (calculated for the first hospitalization date, symptom onset date, and diagnosis date)
2) Fever duration
3) Improvement rate of image findings
4) Number of days until improvement of image findings is confirmed
5) Time required until each of supplemental oxygen / non-invasive ventilation or high-flow oxygen therapy (Nasal high flow) / invasive mechanical ventilation by endotracheal intubation / ECMO (starting date: 1st hospitalization date), Symptom occurrence date, and, Diagnosis date are calculated respectively), the number of days of implementation
6) Hospitalization days
7) Survival period (calculation dates are calculated for 1st hospitalization, 2nd symptom onset, and 3rd diagnosis)
Exploratory analysis:
1) Predictors of treatment effect
2) Clinical course, age, sex, medical history, smoking history, complications, blood sampling test results, therapeutic agents other than tocilizumab

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 A case diagnosed as COVID-19 and administered tocilizumab
Key exclusion criteria Cases where tocilizumab administration was judged to be inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takehiro
Middle name
Last name Izumo
Organization Japanese Red Cross Medical Center
Division name Department of Respiratory Medicine
Zip code 1508935
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email izumo_takehiro@med.jrc.or.jp

Public contact
Name of contact person
1st name Takehiro
Middle name
Last name Izumo
Organization Japanese Red Cross Medical Center
Division name Department of Respiratory Medicine
Zip code 1508935
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Homepage URL
Email izumo_takehiro@med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Red Cross Medical Center
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
Tel 03-3400-1311
Email drtake1118@gmail.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
2020 Year 06 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 Enrolling by invitation
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2020 Year 06 Month 01 Day
Last modified on
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046354

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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