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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||||
Condition | COVID-19 | |||||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Retrospective study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |