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

Phase 2

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Ivermectin 3 MG

• Registration Number: NCT04703205
• Lead Sponsor: Kitasato University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Primary Completion: 2021-10-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-20
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

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.

Exclusion Criteria

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."

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	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.
ivermectin	Ivermectin 3 MG	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.

Primary Outcome Measures

Name	Time	Method
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	15days	Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative

Trial Locations

Locations (1)

Kitasato University; 🇯🇵 Sagamihara, Kanagawa, Japan