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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046106
Receipt No. R000052632
Scientific Title A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19
Date of disclosure of the study information 2021/11/22
Last modified on 2021/11/18

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Basic information
Public title A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19
Acronym A Study to Elucidate the Gastrointestinal mucosal damage in Patients with COVID-19
Scientific Title A Prospective Observational Study to Elucidate the Mechanism of Gastrointestinal Mucosal Damage and Thrombosis in Patients with COVID-19
Scientific Title:Acronym A Study to Elucidate the Gastrointestinal mucosal damage in Patients with COVID-19
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Medicine in general Gastroenterology Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To elucidate the pathogenesis of gastrointestinal mucosal damage in patients with COVID-19.
Basic objectives2 Others
Basic objectives -Others To elucidate the pathogenesis of thrombus formation associated with microcirculatory disturbances in COVID-19 patients.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The severity of COVID-19 and changes in gut microbiota or metabolites
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Male and female, ages 18 or older
2) Be willing to provide informed consent
3) SARS-CoV-2 nucleic acid detection by Real-Time PCR or SARS-CoV-2 antigen by a rapid diagnostic assay in the samples from the nasopharyngeal or oropharyngeal swab, or salvia.
Key exclusion criteria 1) Unconfirmed diagnosis for SARS-CoV-2
2) Rejection or Withdrawn of informed consent
3) Patients judged by the principal investigator to be ineligible.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Nakase
Organization Sapporo medical university
Division name Department of gastroenterology and hepatology
Zip code 060-8543
Address S1W16, Chuo-ku Sapporo, Hokkaido, Japan
TEL 0116112111
Email hiropynakase@gmail.com

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Yokoyama
Organization Sapporo medical university
Division name Department of gastroenterology and hepatology
Zip code 060-8543
Address S1W16, Chuo-ku Sapporo, Hokkaido, Japan
TEL 0116112111
Homepage URL
Email yoshi_yokoyamaa@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Clinical Research, Research Support Division, Sapporo Medical University
Address S1W16, Chuo-ku Sapporo, Hokkaido, Japan
Tel 011-611-2111
Email ji-rskk@sapmed.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
2021 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 07 Month 27 Day
Date of IRB
2021 Year 09 Month 09 Day
Anticipated trial start date
2021 Year 09 Month 09 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For the analysis of gut microbiota and metabolites, samples will be collected again after one week.

Management information
Registered date
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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