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

Primary Purpose

Covid19

Status

Active

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Ivermectin 3 MG

Placebo

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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."

Sites / Locations

Kitasato University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ivermectin

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04703205

First Posted

December 1, 2020

Last Updated

January 18, 2022

Sponsor

Kitasato University

1. Study Identification

Unique Protocol Identification Number

NCT04703205

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 16, 2020 (Actual)

Primary Completion Date

October 22, 2021 (Actual)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kitasato University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ivermectin

Arm Type

Experimental

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ivermectin 3 MG

Intervention Description

Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

15days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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."

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kunihiro K.Y Yamaoka, Ph.D

Organizational Affiliation

Kitasato University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kitasato University

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

COVID-19

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31839144

Citation

Nicolas P, Maia MF, Bassat Q, Kobylinski KC, Monteiro W, Rabinovich NR, Menendez C, Bardaji A, Chaccour C. Safety of oral ivermectin during pregnancy: a systematic review and meta-analysis. Lancet Glob Health. 2020 Jan;8(1):e92-e100. doi: 10.1016/S2214-109X(19)30453-X.

Results Reference

background

PubMed Identifier

30266338

Citation

Lv C, Liu W, Wang B, Dang R, Qiu L, Ren J, Yan C, Yang Z, Wang X. Ivermectin inhibits DNA polymerase UL42 of pseudorabies virus entrance into the nucleus and proliferation of the virus in vitro and vivo. Antiviral Res. 2018 Nov;159:55-62. doi: 10.1016/j.antiviral.2018.09.010. Epub 2018 Sep 26.

Results Reference

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PubMed Identifier

32251768

Citation

Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

Results Reference

background

PubMed Identifier

33065103

Citation

Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study. Chest. 2021 Jan;159(1):85-92. doi: 10.1016/j.chest.2020.10.009. Epub 2020 Oct 13.

Results Reference

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

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