UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
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

英語
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

一般向け試験名略称/Acronym

日本語
Study of Covid-19 LAMP in Indonesia/The Philippines

英語
Study of Covid-19 LAMP in Indonesia/The Philippines

科学的試験名/Scientific Title

日本語
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

英語
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

科学的試験名略称/Scientific Title:Acronym

日本語
Study of Covid-19 LAMP in Indonesia/The Philippines

英語
Study of Covid-19 LAMP in Indonesia/The Philippines

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語
SARS-CoV-2

英語
SARS-CoV-2

疾患区分1/Classification by specialty

感染症内科学/Infectious disease

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
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.

英語
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.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語
Primary Objective: To compare the clinical performance of the test kit with RT-PCR test in COVID-19 diagnosis
Secondary Objectives: To verify the sensitivity and specificity of the LAMP kit to diagnose COVID-19 in populations of different countries.

英語
Secondary Objectives: To verify the sensitivity and specificity of the LAMP kit to diagnose COVID-19 in populations of different countries.

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
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.

英語
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.

副次アウトカム評価項目/Key secondary outcomes

日本語
Secondary: Similar sensitivity and specificity results in the two countries. At least 90% agreement should be achieved.

英語
Secondary: Similar sensitivity and specificity results in the two countries. At least 90% agreement should be achieved.

試験の種類/Study type

観察/Observational

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
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.

英語
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.

除外基準/Key exclusion criteria

日本語
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.

英語
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.

目標参加者数/Target sample size

506

責任研究者/Name of lead principal investigator

日本語

名	Norio
ミドルネーム
姓	Ohmagari

英語

名	Norio
ミドルネーム
姓	Ohmagari

所属組織/Organization

日本語
National Center for Global Health and Medicine

英語
National Center for Global Health and Medicine

所属部署/Division name

日本語
Disease Control and Prevention Center

英語
Disease Control and Prevention Center

郵便番号/Zip code

162-8655

住所/Address

日本語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

英語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

電話/TEL

03-6228-0445

Email/Email

nohmagari@hosp.ncgm.go.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	Maria Ruriko
ミドルネーム
姓	Umano

英語

名	Maria Ruriko
ミドルネーム
姓	Umano

組織名/Organization

日本語
National Center for Global Health and Medicine

英語
National Center for Global Health and Medicine

部署名/Division name

日本語
Department of International Trials

英語
Department of International Trials

郵便番号/Zip code

162-8655

住所/Address

日本語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

英語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

電話/TEL

03-6228-0445

試験のホームページURL/Homepage URL

Email/Email

covidlamphelpdesk@hosp.ncgm.go.jp

機関名/Institute

日本語
その他

英語
National Center for Global Health and Medicine

機関名/Institute
（機関選択不可の場合）

日本語
National Center for Global Health and Medicine

部署名/Department

日本語
Disease Control and Prevention Center

個人名/Personal name

日本語

英語

機関名/Organization

日本語
国立研究開発法人日本医療研究開発機構

英語
AMED

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

日本の官庁/Japanese Governmental office

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
National Center for Global Health and Medicine

英語
National Center for Global Health and Medicine

住所/Address

日本語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

英語
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan

電話/Tel

03-6228-0445

Email/Email

takobayashi@hosp.ncgm.go.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2022

年

09

月

27

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

256

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

2023

年

03

月

31

日

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2021

年

01

月

19

日

倫理委員会による承認日/Date of IRB

2021

年

02

月

02

日

登録・組入れ開始（予定）日/Anticipated trial start date

2021

年

02

月

28

日

フォロー終了(予定)日/Last follow-up date

2022

年

10

月

30

日

入力終了(予定)日/Date of closure to data entry

2022

年

11

月

30

日

データ固定（予定）日/Date trial data considered complete

2022

年

12

月

31

日

解析終了(予定)日/Date analysis concluded

2023

年

01

月

31

日

その他関連情報/Other related information

日本語
N/A

英語
N/A

登録日時/Registered date

2022

年

09

月

27

日

最終更新日/Last modified on

2023

年

03

月

29

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000055862

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055862