COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031200120

Miwa Nonaka

ivm-iit@insti.kitasato-u.ac.jp

2020-09-16

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

1) A person who has been diagnosed with COVID-19 (including asymptomatic) by the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) within 3 days before the qualification test.2) A person with oxygen saturation (SpO2) in the room air of 95% or more.3) A person who are 20 years or older at the time of obtaining consent.4) A person who weigh 40 kg or more at the time of qualification test.5) A person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.

1) A woman who is in lactation period or who may be pregnant, or those who do not agree to prevent pregnancy by medically appropriate means for up to 7 days after study drug administration.Medically appropriate contraception means that using a combination of two or more of the following: not having sexual intercourse, taking surgical sterilization such as vasectomy or intrauterine device, taking oral contraceptive, using condom.2) A person who has severe liver damage (AST or ALT at the time of qualification test is more than 3 times the upper limit of institutional standard and total bilirubin is more than twice the upper limit of institutional standard value), renal disorder (eGFR of eligibility test value 30 mL/min/1.73m2 or less).3) A person with hypersensitivity to ivermectin.4) A person with a history of severe drug allergies such as Stevens-Johnson syndrome, toxic epidermal necrolysis.5) A person who has received the prohibited medication within the past month (within the past 6 months for biologics), or those who need to use the prohibited medication during the clinical trial period.6) Those who are scheduled to receive SARS-CoV-2 vaccination from the date of consent to the end of the follow-up period.7) A person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent.8) In addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator.

2

Yamaoka Kunihiro

20

100

Japan

Mild disease at enrollment

1: Mild disease at enrollment

240

Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]