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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043821
Receipt No. R000050013
Scientific Title A study of causative microorganisms and usefulness of various tests in patients with suspected COVID-19
Date of disclosure of the study information 2021/04/03
Last modified on 2021/04/02

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Basic information
Public title A study of causative microorganisms and usefulness of various tests in patients with suspected COVID-19
Acronym A study of causative microorganisms and usefulness of various tests in patients with suspected COVID-19
Scientific Title A study of causative microorganisms and usefulness of various tests in patients with suspected COVID-19
Scientific Title:Acronym A study of causative microorganisms and usefulness of various tests in patients with suspected COVID-19
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of causative microorganisms
Basic objectives2 Others
Basic objectives -Others Evaluation of the usefulness of the test
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes FilmArray Respiratory Panel 2.1 Test Results (including SARS-CoV2)
Key secondary outcomes Presence of other microbial infections in SARS-CoV-2 PCR-positive patients
SARS-CoV-2 PCR results by GeneSoC.
Test results of FilmArray Respiratory Panel 2.1 compared to SARS-CoV-2 PCR
Sensitivity, Specificity and Minimum Detection Sensitivity of SARS-CoV-2 Antibody Test Reagent Kits (IgM, IgG) and COVID-19 IgG/IgM Immunochromatographic Kit

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 Patients suspected to have COVID-19 and underwent SARS-CoV2 PCR test during the study period (after Ethics Committee approval - March 31, 2022)
Selection Criteria
1. patients with pneumonia requiring hospitalization who need to be differentiated from COVID-19
Patients who have been in contact with a confirmed COVID-19 patient or have traveled to an endemic area within 14 days of onset and require hospitalization.
2. Patients with fever of 37.5 degree or higher and symptoms such as cough, sputum, sore throat, chest pain, dyspnea, malaise, arthralgia, myalgia, anorexia, and diarrhea
3. Acute onset taste or smell disorder
Definition of endemic areas: Areas with COVID-19 infections of 0.3/100,000 population or more in the last week. 4.
4. patients aged 20 years or older at the time of nasopharyngeal swab specimen collection
Key exclusion criteria 1. If the participant is judged to be ineligible for research.
2. those who refuse to participate in the research
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Fukumori
Organization Nara Medical University
Division name Center for Infectious Diseases
Zip code 634-8522
Address 840 Shijo-Cho, Kashihara, Nara, Japan
TEL 0744-22-3051
Email t-fukumori@naramed-u.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Fukumori
Organization Nara Medical University
Division name Center for Infectious Diseases
Zip code 634-8522
Address 840 Shijo-Cho, Kashihara, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email t-fukumori@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Center for Infectious Diseases
Institute
Department

Funding Source
Organization KYORIN Holdings, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University Bioethics Supervision Office
Address 840 Shijo-Cho, Kashihara, Nara, Japan
Tel 0744-22-3051
Email t-fukumori@naramed-u.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 04 Month 03 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 19 Day
Date of IRB
2020 Year 03 Month 27 Day
Anticipated trial start date
2020 Year 03 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study

Management information
Registered date
2021 Year 04 Month 02 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050013

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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