COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04703205

Kitasato University

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

2021-01-11

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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. a person with oxygen saturation (spo2) in the room air of 95% or more. a person who are 20 years or older at the time of obtaining consent. a person who weigh 40 kg or more at the time of qualification test. a person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.

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. 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). a person with hypersensitivity to ivermectin. a person with a history of severe drug allergies such as stevens-johnson syndrome, toxic epidermal necrolysis. 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. those who are scheduled to receive sars-cov-2 vaccination from the date of consent to the end of the follow-up period. a person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent. in addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator."

2

Kitasato University

20

100

Japan

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

214

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

None

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"}]