UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042061
Receipt number R000047878
Scientific Title "Study of resistance to COVID-19 of medical staff" -(Pilot Study)-
Date of disclosure of the study information 2020/10/09
Last modified on 2023/04/11 10:26:39

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Basic information

Public title

"Study of resistance to COVID-19 of medical staff" -(Pilot Study)-

Acronym

"Study of resistance to COVID-19 of medical staff" -(Pilot Study)-

Scientific Title

"Study of resistance to COVID-19 of medical staff" -(Pilot Study)-

Scientific Title:Acronym

"Study of resistance to COVID-19 of medical staff" -(Pilot Study)-

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the internal characteristics of healthcare workers who did not become infected with this disease even through close contact, in contrast to those infected.

Basic objectives2

Others

Basic objectives -Others

Elucidate the factors of mental stress of medical staff who treat COVID-19, and develop and develop stress reduction methods

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IFNlamda4 gene polymorphism

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

(1) Persons infected with the new coronavirus (infected persons) and persons who did not become infected despite having similar contact with infected persons (non-infected close contacts)
(2) Gender: No matter
(3) Target age: 20 years old and over
(4) Subjects who have obtained their consent to participate in this test

Key exclusion criteria

(1) Those who are positive for PCR test at the time of obtaining consent
(2) Persons who have symptoms of suspected infection such as COVID-19 at the time of obtaining consent
(3) Others who are judged by the doctor in charge to be inappropriate for this study

Target sample size

165


Research contact person

Name of lead principal investigator

1st name Kunihiro
Middle name
Last name Yamagata

Organization

University of Tsukuba

Division name

Department of nephrology, faculty of medicine

Zip code

3058575

Address

1-1-1, Tennnodai, Tsukuba, Ibaraki

TEL

0298533202

Email

k-yamaga@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Hirayasu
Middle name
Last name Kai

Organization

University of Tsukuba

Division name

Department of nephrology, faculty of medicine

Zip code

3058575

Address

1-1-1, Tennnodai, Tsukuba, Ibaraki

TEL

0298533202

Homepage URL


Email

hirayasu.kai@md.tsukuba.ac.jp


Sponsor or person

Institute

other

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of nephrology, faculty of medicine

Address

1-1-1, Tennnodai, Tsukuba, Ibaraki

Tel

0298533022

Email

sien.ningenss@un.tsukuba.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 10 Month 09 Day


Related information

URL releasing protocol

https://nephtsukuba.wixsite.com/nephrology-tsukuba/blank

Publication of results

Partially published


Result

URL related to results and publications

https://www.frontiersin.org/articles/10.3389/fmicb.2022.943877/full

Number of participants that the trial has enrolled

166

Results

We found that rs12329760 in the TMPRSS2 gene, a missense variant common in East Asian populations, contributes to protection against SARS-CoV-2 infection. TMPRSS2 is a protease responsible for SARS-CoV-2 entry and syncytium formation. rs12329760 (c.478G>A, p. V160M) was associated with a reduced risk of moderate symptoms. East Asian-specific genetic variation in TMPRSS2 is one of the molecular determinants of COVID-19 susceptibility and severity.

Results date posted

2023 Year 04 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Persons infected with novel coronavirus and non-infected close contacts

Participant flow

Medical interview, stress survey, clinical examination, specimen collection for genetic testing

Adverse events

None

Outcome measures

Primary endpoint IFNlamda4 gene polymorphism
Secondary endpoints
MxA gene polymorphism
Percentage of anti-COVID-19 antibody titer positive
T-Spot positivity rate
Laboratory findings, serum cytokine levels, etc.
Evaluation of stress status and stress tolerance

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 09 Month 25 Day

Date of IRB

2020 Year 09 Month 25 Day

Anticipated trial start date

2020 Year 09 Month 25 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(Primary endpoint) IFN-lamda4 gene polymorphism
(Secondary evaluation item)
(1) MxA gene polymorphism
(2) Anti-COVID-19 antibody titer positive rate
(3) T-Spot positive rate
(4) Values of each clinical laboratory finding, serum cytokine, etc.
(5) Evaluation of stress status and stress tolerance


Management information

Registered date

2020 Year 10 Month 09 Day

Last modified on

2023 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047878


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name