COVID-19: Ivermectin clinical trial in Japan: Kowa double-blind
-Consult with PMDA for corona treatment-
Kowa (Nagoya City):
Started “Clinical trial of ivermectin efficacy and safety in mildly ill patients” in Japan.
Kowa Co., Ltd. (Nagoya City), which handles pharmaceutical products, announced on July 1st.
Ivermectin:
A drug developed by Satoshi Omura and Kitasato University Special Honorary Professor in 2015.
It has already been approved as a treatment for infectious diseases and skin infections caused by mites.
WHO not approved:
World Health Organization (WHO) March 2021
“Guidelines for not recommending ivermectin as a new corona treatment” were announced.
“The effect of ivermectin is uncertain, and there are many unclear points about the mechanism.”
In Japan, ivermectin has not yet been approved as a new treatment for corona.
Kitasato University Hospital clinical trial:
Kitasato University Hospital started a doctor-led clinical trial in September 2020, mainly for mildly ill patients.
However, it is behind schedule.
The clinical trial will be realized by Mr. Omura asking Kowa.
Request a clinical trial from Kowa:
Consultation with PMDA
Discussed clinical trial method and start time with Pharmaceuticals and Medical Devices Agency (PMDA), which is in charge of drug screening.
For 1,000 patients
At this stage, about 1,000 patients are targeted within about 3 days after a positive result is found in Tokyo, Osaka, Nagoya, etc.
Double-blind clinical trial
The plan is to use a “double-blind” method in which neither doctors nor patients know whether the drug is a placebo or a placebo.
Kowa’s intention
Mutsuo Okumura, General Manager of Research and Development Division, said, “We want to start as soon as possible. aim to finish the clinical trial by the end of the year.”
Asahi Shimbun Digital