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

January 18, 2022 updated by: KUNIHIRO YAMAOKA, Kitasato University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, COVID-19
        • Kitasato University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ivermectin
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
Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)
Placebo Comparator: 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.
Drug: Placebo
Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kitasato University

Investigators

  • Principal Investigator: Kunihiro K.Y Yamaoka, Ph.D, Kitasato University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Actual)

October 22, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORVETTE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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