UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040295 |
|---|---|
| Receipt number | R000045974 |
| Scientific Title | Prospective observational study on diagnosis and treatment of COVID-19 |
| Date of disclosure of the study information | 2020/05/02 |
| Last modified on | 2020/05/02 18:43:51 |
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Basic information
Public title
Prospective observational study on diagnosis and treatment of COVID-19
Acronym
J-COVID
Scientific Title
Prospective observational study on diagnosis and treatment of COVID-19
Scientific Title:Acronym
J-COVID
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Radiology | Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
establishing of COVID-19 criteria for medical examinations and tests necessary for collecting information on medical conditions and medical treatment contents, grasps changes in medical conditions over time, and extracts medical problems.
Basic objectives2
Others
Basic objectives -Others
(1) Contribute to better medical condition management by grasping the overall picture of the medical condition, extracting problems, and considering countermeasures.
(2) Order to accumulate common data, it is necessary to formulate and implement the minimum standard of medical care contents.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aggravation rate
Recovery rate
Number of days until COVID-19 becomes negative
Presence of complications
Treatment content
Correlation between the results obtained by SARS-CoV-2 antibody test and real time PCR, next-generation sequencing, immunochromatography and blood sampling test items
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with COVID-19
Key exclusion criteria
Patients who refused to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
150-8935
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
Respiratory Medicine
Zip code
150-8935
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
izumo_takehiro@med.jrc.or.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 | 05 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045974
