NCT04703205

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Kitasato University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Ivermectin 3 MG	Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)
DRUG	Placebo	Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)

Timeline

• Start date: 2020-09-16
• Primary completion: 2021-10-22
• Completion: 2022-05-31
• First posted: 2021-01-11
• Last updated: 2022-01-20

Locations

1 site across 1 country: Japan