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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

基本情報

進捗状況	試験終了
対象疾患	SARS-CoV-2
試験開始日（予定日）	2021-02-28
目標症例数	506
臨床研究実施国	アジア（日本以外）
研究のタイプ	観察

試験の内容

主要アウトカム評価項目	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	Secondary: Similar sensitivity and specificity results in the two countries. At least 90% agreement should be achieved.

対象疾患

年齢（下限）
年齢（上限）
性別	3
選択基準	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	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.