UMIN-CTR Clinical Trial

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

COVID-19

Classification by specialty

Medicine in general

Infectious disease

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

IFNlamda4 gene polymorphism

Key secondary outcomes

Study type

Observational

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

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

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

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

Institute

other

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

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

10

Month

09

Day

URL releasing protocol

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

Publication of results

Partially published

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

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 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

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