UMIN-CTR Clinical Trial

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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