UMIN-CTR Clinical Trial

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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