UMIN-CTR Clinical Trial

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
Email	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
Email	horitano@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045582