UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040614 |
|---|---|
| Receipt number | 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 19:53:19 |
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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
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
izumo_takehiro@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046354
