This is a Phase 2 clinical trial sponsored by Kitasato University and Kowa Co Ltd.
The trial is to study the treatment of mild COVID-19 which 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 Phase 2 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.
Kowa Co Ltd said on Monday anti-parasite drug ivermectin has been found effective for treating the Omicron variant of COVID-19 in a clinical trial.