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

NCT04703205 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2022-01-20

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Kitasato University

    lead OTHER

Principal Investigators

  • Kunihiro K.Y Yamaoka, Ph.D · Kitasato University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-10-22
Completion
2022-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703205 on ClinicalTrials.gov