1/31/22, 4
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12 PMPlacebo-controlled randomized double-blind test (evaluator, patient) mul… clinical trial information [Clinical Research Information Portal Site]Page 1 of 9https://rctportal.niph.go.jp/s/detail/um
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trial_id=jRCT2031200120
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Last updated: November 7, 2021
Test ID jRCT2031200120
Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel group comparison trial to examine the efficacy andsafety of Ivermectin for COVID-19 patients
Basic information
test IDjRCT2031200120Scientific Title (Acronym)Placebo-controlled randomized double-blind (evaluators, patients) multi-facility joint parallel group comparison trial to examine the efficacy and safety of Ivermectin for COVID-19 patientsA placebo-controlled, randomized, double-blind study in COvid-19 patients with iveRmectin; An inVEstigator iniTiaTEd trialPublic Title (Acronym)double-blind study in COvid-19 patients with iveRmectinExam progress/Recruitment statusCall for participants has ended - the exam is ongoing.not recruitingregistration date and timeSeptember sixteenth, 2020Last updated dateNovember 7, 2021Test start date (scheduled date)September 16, 2020Examination end date (planned date)March 31, 2022Date of first enrollmentSeptember sixteenth, 2020
Exam summary
Test area / RegionJapanJapanImplementation prefectureTokyo
1/31/22, 4
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12 PMPlacebo-controlled randomized double-blind test (evaluator, patient) mul… clinical trial information [Clinical Research Information Portal Site]Page 2 of 9https://rctportal.niph.go.jp/s/detail/um
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trial_id=jRCT2031200120
Target number of cases/Target sample size240Target disease / Health condition(s) or Problem(s) studiedCOVID-19COVID-19Study typeinterventionInterventionalStudy designRandomizationintervention 1Ivermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention twoIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention threeIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention fourIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) o
1/31/22, 4
!
12 PMPlacebo-controlled randomized double-blind test (evaluator, patient) mul… clinical trial information [Clinical Research Information Portal Site]Page 3 of 9https://rctportal.niph.go.jp/s/detail/um
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trial_id=jRCT2031200120
n Day 1. Take Sebo tablets) per subject's weight.intervention fiveIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention sixIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention sevenIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention eightIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets) or the contrast drug (Ivermectin pla) on Day 1. Take Sebo tablets) per subject's weight.intervention nineIvermectin group: About 200µg/kg of Ivermectin is administered on a single oral day 1 (on an empty stomach) Placebo group: Placebos that do not contain Ivermectin as ingredients are administered on a single oral day 1 (on an empty stomach) Subjects will use the study drug (Ivermectin 3mg tablets)