UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040617 |
|---|---|
| Receipt number | R000046356 |
| Scientific Title | A retrospective study on serum markers in the diagnosis and differentiation of COVID-19 |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/06/01 20:48:10 |
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Basic information
Public title
A retrospective study on serum markers in the diagnosis and differentiation of COVID-19
Acronym
J-COVID-R
Scientific Title
A retrospective study on serum markers in the diagnosis and differentiation of COVID-19
Scientific Title:Acronym
J-COVID-R
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
Consider useful blood tests for COVID-19 diagnosis and identification
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between blood test results and SRAS-CoV-2 PCR results
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with COVID-19 by real time PCR and patients with normal pneumonia other than COVID-19 in our Department of Respiratory Medicine during the same period or the past 5 years (including diffuse lung disease)
Key exclusion criteria
Patients who COVID-19 not equal non-decision
Target sample size
200
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 | 03 | Month | 26 | 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=R000046356
