UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043821 |
|---|---|
| Receipt number | 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 16:26:10 |
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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
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
t-fukumori@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Center for Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050013
