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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041226
Receipt No. R000045903
Scientific Title Study of clinical characteristics of acute stroke with COVID-19
Date of disclosure of the study information 2020/07/27
Last modified on 2020/07/27

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Basic information
Public title Study of clinical characteristics of acute stroke with COVID-19
Acronym Study of clinical characteristics of acute stroke with COVID-19
Scientific Title Study of clinical characteristics of acute stroke with COVID-19
Scientific Title:Acronym Study of acute stroke with COVID-19
Region
Japan

Condition
Condition stroke
Classification by specialty
Neurology Neurosurgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the characteristics of patients with stroke in confirmed COVID-19
Basic objectives2 Others
Basic objectives -Others To study the management, treatment, and outcome of patients with stroke in confirmed COVID-19
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical characteristics of patients with acute stroke for confirmed COVID-19
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with acute stroke in confirmed COVID-19
2) Positive results for COVID-19 based on reverse transcriptase-polymerase chain reaction (RT-PCR) after patients were admitted with acute stroke (including hospital-acquired infection)
Key exclusion criteria Patients judged as inappropriate for this study by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazumi
Middle name
Last name Kimura
Organization Nippon Medical School
Division name department of neurology
Zip code 1138603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Email k-kimura@nms.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Nishiyama
Organization Nippon Medical School
Division name department of neurology
Zip code 1138603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Homepage URL
Email nomo16@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor the Japan Stroke Society
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nippon Medical School IRB
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel 0338222131
Email c-ethics@nms.ac.jp

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 07 Month 27 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 06 Month 22 Day
Date of IRB
2020 Year 07 Month 08 Day
Anticipated trial start date
2020 Year 07 Month 08 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is approved by the Japan Stroke Society.
The study is a multi-center, retro-prospective observational study and the study period is between 2020/1/1 and 2021/5/31 but will be finished up to a total of 100 patients who are registered.

Management information
Registered date
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045903

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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