UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040616
Receipt number R000046355
Scientific Title Retrospective study on clinical and pathological aspects of COVID-19
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/01 20:17:26

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Basic information

Public title

Retrospective study on clinical and pathological aspects of COVID-19

Acronym

J-COVID-RP

Scientific Title

Retrospective study on clinical and pathological aspects of COVID-19

Scientific Title:Acronym

J-COVID-RP

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Medicine in general Pneumology Infectious disease
Laboratory medicine Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigating treatment by examining the clinical findings of COVID-19 patients with pathological histology

Basic objectives2

Others

Basic objectives -Others

Clinicopathological examination

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pathological results (including immunostaining and virus search)

Key secondary outcomes

Clinical course, age, sex, medical history, smoking history, complications, test results, therapeutic agents, presence / absence of artificial respiration management, use of artificial lung (ECMO), chest XP, CT images


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

Patients diagnosed with COVID-19 who were biopsyable (including autopsy and necropsy at death)

Key exclusion criteria

Cases where the biopsy was judged inappropriate

Target sample size

5


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 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

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 clinical pathology 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=R000046355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name