UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039986 |
|---|---|
| Receipt number | R000045582 |
| Scientific Title | Risk factors of death from coronavirus disease 2019 |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/12/20 12:17:53 |
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Basic information
Public title
Risk factors of death from coronavirus disease 2019
Acronym
Risk factors of death from coronavirus disease 2019
Scientific Title
Risk factors of death from coronavirus disease 2019
Scientific Title:Acronym
Risk factors of death from coronavirus disease 2019
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
World Health Organization declared pandemic of coronavirus disease 2019 (COVID-19) on March 11th, 2020. As of Mar 28th, more than 640,000 infected cases and 30,000 deaths were reported from 183 countries and territories. Currently, no vaccination and antivirus medication have been proved to be effective for prevention or treatment of this infectious disease. Rapidly expanding COVID-19 has led to social lock down and medical system collapse of some cities in China, South Korea, USA, Italy, Spain and other European countries. While each city or region has limited medical resources, it is known that young infected individuals who do not have any comorbidity usually recover without any medical care. Therefore, we should utilize limited medical resources such as beds, medication, human resources, respirators, and intensive care unit for people with high risk of death. Some published research papers revealed risk factor2 of death such as being a male, higher age, and smoking history. However, there was a considerable discrepancy among reports. The goal of this systematic review is to summarize the data of fetal risk from COVID-19.
Basic objectives2
Others
Basic objectives -Others
To identify risk factor of death from COVID-19
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Odds ratio for death
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Individuals with COVID-19
Key exclusion criteria
NA
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Jaapn
TEL
0457872800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Jaapn
TEL
0457872800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
NA
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
NA
Address
NA
Tel
0457872800
horitano@yokohama-cu.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 | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000039986
Publication of results
Published
Result
URL related to results and publications
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000039986
Number of participants that the trial has enrolled
999999
Results
Please see:
Risa Ebina-Shibuya et al. Respirology. 2020 Aug;25(8):898-899.
Results date posted
| 2021 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see:
Risa Ebina-Shibuya et al. Respirology. 2020 Aug;25(8):898-899.
Participant flow
Please see:
Risa Ebina-Shibuya et al. Respirology. 2020 Aug;25(8):898-899.
Adverse events
Please see:
Risa Ebina-Shibuya et al. Respirology. 2020 Aug;25(8):898-899.
Outcome measures
Please see:
Risa Ebina-Shibuya et al. Respirology. 2020 Aug;25(8):898-899.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The protocol follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Institutional review board approval and patient consent were not required because of the review nature of this study. The protocol was registered at Japanese University hospital Medical Information Network (UMIN) Center.
We will systematically search PubMed, EMBASE, Web of Science and conduct hand searching using the following wordings: nCoV, COVID, 2019-nCoV, and SARS-CoV-2. Both prospective and retrospective study that provide data regarding risk factor for death among people with COVID-19. Two review authors will screen and full-text scrutinize to identify eligible articles.
A case report with less than five case was excluded from our analysis.
The primary outcome of our analysis is odds ratio for death for each risk factor compared to those without the risk factor.
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045582
