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

• ClinicalTrials.gov Identifier: NCT04703205
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2021
• Last Update Posted: January 20, 2022
• Sponsor: Kitasato University
• Information provided by (Responsible Party): KUNIHIRO YAMAOKA, Kitasato University

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.

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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

Eligibility Criteria

• 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."

Contacts and Locations

Locations

Japan

Kitasato University

Sagamihara, Kanagawa, Japan, COVID-19

Sponsors and Collaborators

Kitasato University

Investigators

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

More Information

Publications:

Nicolas P, Maia MF, Bassat Q, Kobylinski KC, Monteiro W, Rabinovich NR, Menéndez C, Bardají 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.

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.

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.

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.

• Responsible Party: KUNIHIRO YAMAOKA, KitasatoUniversity SchoolofMedicine Professor, Kitasato University
• ClinicalTrials.gov Identifier: NCT04703205
• Other Study ID Numbers: CORVETTE-01
• First Posted: January 11, 2021
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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