We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04703205
Recruitment Status : Active, not recruiting
First Posted : January 11, 2021
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
KUNIHIRO YAMAOKA, 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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin 3 MG Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : October 22, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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)




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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."

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703205


Locations
Layout table for location information
Japan
Kitasato University
Sagamihara, Kanagawa, Japan, COVID-19
Sponsors and Collaborators
Kitasato University
Investigators
Layout table for investigator information
Principal Investigator: Kunihiro K.Y Yamaoka, Ph.D Kitasato University Hospital
Publications:
Layout table for additonal information
Responsible Party: KUNIHIRO YAMAOKA, KitasatoUniversity SchoolofMedicine Professor, Kitasato University
ClinicalTrials.gov Identifier: NCT04703205    
Other Study ID Numbers: CORVETTE-01
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents