UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040219
Receipt number R000045877
Scientific Title A prospective cohort study to follow the health status of medical staff engage in COVID-19
Date of disclosure of the study information 2020/04/22
Last modified on 2021/11/25 05:15:18

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Basic information

Public title

A prospective cohort study to follow the health status of medical staff engage in COVID-19

Acronym

A prospective cohort study to medical staff engage in COVID-19

Scientific Title

A prospective cohort study to follow the health status of medical staff engage in COVID-19

Scientific Title:Acronym

A prospective cohort study to medical staff engage in COVID-19

Region

Japan


Condition

Condition

medical staff engage in COVID-19

Classification by specialty

Medicine in general Infectious disease Emergency medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To follow up the health status of medical stuff engage in COVID-19

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of COVID-19 markers in medical staff engage in COVID-19

Key secondary outcomes

The health status of medical staff engage in COVID-19


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

medical staffs engaged in COVID-19 in Yokohama City University

Key exclusion criteria

not willing to participate the study
judged as being inappropriate candidates for the trial by the investigators

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takuma
Middle name
Last name HIGURASHI

Organization

Yokohama City University

Division name

Department of gastroenterology and hepatology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan

TEL

045-787-2800

Email

takuma_h@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Takuma
Middle name
Last name HIGURASHI

Organization

Yokohama City University

Division name

Department of gastroenterology and hepatology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan

TEL

045-787-2800

Homepage URL


Email

takuma_h@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Yokohama City University Hospital IRB

Address

3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan

Tel

045-370-7627

Email

rinri@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

横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 22 Day


Related information

URL releasing protocol

doi: 10.1016/j.jiph.2021.08.016.

Publication of results

Published


Result

URL related to results and publications

doi: 10.1016/j.jiph.2021.08.016.

Number of participants that the trial has enrolled

10

Results

Ten doctors worked as Team COVID: seven internal medicine doctors and three surgeons. During the study period, Team COVID treated 165 individuals in the outpatient clinic and isolated hospitalized patients for 315 person-days. There were no positive results of serum-specific antibody testing and PCR testing for SARS-CoV-2 in Team COVID doctors. Furthermore, the SF-36 showed no deterioration in physical and mental QOL status. No in-hospital infection occurred during the study period.

Results date posted

2021 Year 11 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 18 Day

Baseline Characteristics

Physicians tackeling to COVID-19

Participant flow

Physicians aproved to participate the study

Adverse events

none

Outcome measures

SARS-CoV-2 antibody
SARS-CoV-2 PCR
SF-36

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 04 Month 21 Day

Date of IRB

2020 Year 04 Month 22 Day

Anticipated trial start date

2020 Year 04 Month 23 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2020 Year 04 Month 22 Day

Last modified on

2021 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name