COVID-19: Kitasato University begins clinical trial of ivermectin: Registration: jRCT2031200120
Kitasato Institute:
On September 16, 2020, the detailed design of the clinical trial was released in the database (jRCT) that summarizes information on clinical studies in Japan.
Research Outline What is the Public System (jRCT)?
The Clinical Research Implementation Plan / Research Outline Public System (jRCT) is a database that summarizes information such as clinical research in Japan.
Ivermectin clinical trial:
The trial is:
For mild and moderate COVID-19 patients,
Random, double-blind, placebo-controlled trial.
(Registration number: jRCT2031200120)
Subject:
PCR test positive for new coronavirus (SARS-CoV-2) within 3 days prior to eligibility test,
Oxygen saturation (SpO2) is 95% or higher,
Weight at the time of eligibility test is 40 kg or more,
Adult patients who meet the following conditions are subjects.
240 subjects:
The group receiving ivermectin (200 μg / kg given orally once on the first day) and
Allocate evenly to the placebo group on the same schedule.
Primary endpoint:
The period until SARS-CoV-2 became negative in the PCR test was used.
Kitasato Institute spokesperson:
This doctor-initiated clinical trial was adopted in July 2020 under the theme of AMED’s “Development of therapeutic agents for COVID-19”.
Regarding clinical trial design:
The effectiveness of ivermectin,
To make a strict judgment
Explained that a placebo group was set up.
MSD and others cooperate:
In addition, with the cooperation of MSD, the manufacturer and distributor, arrangements for investigational drugs have been completed.
Subject recruitment is in progress and administration will begin in the near future.
The end date of the test is undecided, but MSD will be in charge of subsequent research and development.
Nikkei Biotech ONLINE
https://bio.nikkeibp.co.jp/atcl/news/p1/20/09/17/07408/
About the start of a doctor-initiated clinical trial of ivermectin for new coronavirus infection
Kitasato University Hospital
A doctor-initiated clinical trial will be started with the aim of adding indications for ivermectin to COVID-19.
This clinical trial is positioned as part of the COVID-19 research project “COVID-19 Countermeasure Kitasato Project”.
Kunihiro Yamaoka (Professor, Department of Internal Medicine, Collagen Disease, Kitasato University School of Medicine) will be the clinical trial coordinator.
https://www.kitasato.ac.jp/jp/news/20200917-02.html
Prominent Japanese Academic Medical Center Launching Ivermectin Clinical Trial Targeting COVID-19
The Study
This randomized, controlled trial will include two groups including the ivermectin group and placebo group.
The hospital seeks to assess the changes in symptoms to assess the safety and efficacy of ivermectin.
The Japanese university seeks 240 patients with mild to moderate COVID-19.
Operated by the Kitasato Institute,
this study seeks to example safety and efficacy to secure Japanese approval for ivermectin as a treatment against COVID-19.
The Trial Site Kitasato University
is a private medical university headquartered in Shirokane, Minato, Tokyo Japan.
The university is ranked by Times Higher Education among the top 350 in Asia.