UMIN-CTR Clinical Trial

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

COVID-19

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Odds ratio for death

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University

Institute

Department

Personal name

Organization

NA

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NA

Address

NA

Tel

0457872800

Email

horitano@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

03

Month

31

Day

URL releasing protocol

https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000039986

Publication of results

Published

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

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 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.

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