UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049030 |
|---|---|
| Receipt number | R000055862 |
| Scientific Title | International Study of clinical performance of LoopampTM SARS-CoV-2 in comparison with real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for COVID-19 diagnosis in Indonesia/The Philippines |
| Date of disclosure of the study information | 2022/09/27 |
| Last modified on | 2023/03/29 12:26:22 |
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Basic information
Public title
International Study of clinical performance of LoopampTM SARS-CoV-2 in comparison with real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for COVID-19 diagnosis in Indonesia/The Philippines
Acronym
Study of Covid-19 LAMP in Indonesia/The Philippines
Scientific Title
International Study of clinical performance of LoopampTM SARS-CoV-2 in comparison with real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for COVID-19 diagnosis in Indonesia/The Philippines
Scientific Title:Acronym
Study of Covid-19 LAMP in Indonesia/The Philippines
Region
| Asia(except Japan) |
Condition
Condition
SARS-CoV-2
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
COVID-19 continues to be a global threat. Accurate identification of infected individuals is necessary to abate and contain disease transmission. LoopampTM SARS-CoV-2 is a highly sensitive and specific kit for COVID-19 detection that employs a rapid (35-45 minutes) nucleic acid amplification technique. Moreover, it is portable, easy to handle, and cost-effective, thus enabling high rate of testing which is critical during pandemic, particularly in countries with high number of reported cases. This prospective, single/multicenter study will investigate the clinical performance of COVID-19 LAMP, in terms of sensitivity and specificity, compared to standard RT-PCR method currently applied in Indonesia and the Philippines.
Basic objectives2
Others
Basic objectives -Others
Secondary Objectives: To verify the sensitivity and specificity of the LAMP kit to diagnose COVID-19 in populations of different countries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary: 100 positive and 100 negative test results from whom nasopharyngeal swabs were collected as samples. The overall agreement rate of 90% or greater between the test results of RT-PCR test and the LAMP kit should be achieved.
Key secondary outcomes
Secondary: Similar sensitivity and specificity results in the two countries. At least 90% agreement should be achieved.
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) Those assessed by the investigator or sub-investigator(s) to have symptoms of SARS-CoV-2 infection based on the national guideline for COVID-19 in each country (Indonesia/The Philippines).14,15
2) Those from whom nasopharyngeal swab sample can be collected.
3) Those whose written consent is voluntarily provided or legally represented to participate in the study.
4) Those who are 18 years or older.
Key exclusion criteria
1) Patients with mucosal damage or nasopharyngeal lesions.
2) Patients with nasopharyngeal pain, trauma or nasal surgery within the last 1 month, significantly deviant nasal septum, history of chronically obstructed nasal passages, and severe coagulation disorders.
3) Patients suspected of having used an illicit drug within the last 12 months.
4) Patients determined to be ineligible by the investigator.
Target sample size
506
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ohmagari |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-6228-0445
nohmagari@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Maria Ruriko |
| Middle name | |
| Last name | Umano |
Organization
National Center for Global Health and Medicine
Division name
Department of International Trials
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-6228-0445
Homepage URL
covidlamphelpdesk@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
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
National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel
03-6228-0445
takobayashi@hosp.ncgm.go.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
| 2022 | Year | 09 | Month | 27 | 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
256
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055862
