UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040587
Receipt number R000046321
Scientific Title The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Date of disclosure of the study information 2020/06/01
Last modified on 2021/11/25 05:16:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy

Acronym

The analysis of COVID-19 on gastrointestinal endoscopy

Scientific Title

The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy

Scientific Title:Acronym

The analysis of COVID-19 on gastrointestinal endoscopy

Region

Japan


Condition

Condition

Participants who receive endoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the positive rate of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The positive rate of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy

Key secondary outcomes

The value of COVID-19 antibody
The purpose of endoscopy
The patients background


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

The all patients who receive endoscopy

Key exclusion criteria

COVID-19 suspected from questionnaire and medical interview
Not willing to participate this study
Emergency endoscopy

Target sample size

500


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

222-0037

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

Yokohama City University

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

045-787-2800

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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1111/den.13945

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1111/den.13945

Number of participants that the trial has enrolled

792

Results

Results: A total of 783 samples (560 upper GIE and 223 lower GIE samples) were analyzed. Polymerase chain reaction (PCR) on saliva samples did not show any positive results in either upper or lower GIE samples. However, 2.0% (16/783) of gastrointestinal fluid samples tested positive for SARS-CoV-2. No significant differences in age, sex, purpose of endoscopy, medication, or rate of antibody test positivity were found between PCR positive and PCR negative cases.

Results date posted

2021 Year 02 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 02 Month 06 Day

Baseline Characteristics

The study was a single-center cross-sectional study. From June 1 to July 31, 2020, all patients who underwent GIE at Yokohama City University Hospital were registered. All patients provided 3 mL of saliva. For upper GIE, 10 mL of gastric fluid was collected through the endoscope. For lower GIE, 10 mL of intestinal fluid was collected through the endoscope.

Participant flow

The study was a single-center cross-sectional study. From June 1 to July 31, 2020, all patients who underwent GIE at Yokohama City University Hospital were registered. All patients provided 3 mL of saliva. For upper GIE, 10 mL of gastric fluid was collected through the endoscope. For lower GIE, 10 mL of intestinal fluid was collected through the endoscope.

Adverse events

none

Outcome measures

The primary outcome was the positive rate of SARS-CoV-2 in saliva and gastrointestinal fluids. We also analyzed serum-specific antibodies for SARS-CoV-2 and patients' background information.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 05 Month 13 Day

Date of IRB

2020 Year 05 Month 13 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 08 Month 31 Day

Date analysis concluded

2020 Year 09 Month 14 Day


Other

Other related information

Observational study


Management information

Registered date

2020 Year 05 Month 29 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=R000046321


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name