Study in COvid-19 Patients With iveRmectin (CORVETTE-01)

Study Overview
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Brief Summary
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Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. This study will investigate whether ivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderate COVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlled trial. Subjects are assigned to two groups, the placebo group, and the ivermectin group. The target number of each treatment arm is 120, a total of 240 cases. A single oral administration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will be administered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primary endpoint with additional efficacy and safety of the process will be investigated.

Official Title
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A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial

Conditions
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Covid19

Intervention / Treatment
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* Drug: Ivermectin 3 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ivermectin<br>Ivermectin group: Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state) subjects take the study drug (3 mg tablet of ivermectin) at the dose of the study drug taken once per body weight of the subject. | Drug: Ivermectin 3 MG<br>* Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)<br>|
| Placebo Comparator: placebo<br>Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state) the control drug (ivermectin placebo tablet) at the dose of the study drug taken once per body weight of the subject. | Drug: Placebo<br>* Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative | 15days |