Clinical Trial TitleStudy of Treatment for Human Monkeypox Virus (STOMP)
National Clinical Trial Number:NCT05534984
Clinical Trial Protocol Description:
A5418 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study measuring the clinical and antiviral effects of an oral medication in children and adults with severe monkeypox, or at a high risk of severe monkeypox. Study participants with symptomatic monkeypox virus infection who do not meet the criteria for the open-label cohort will be randomly assigned in a ratio of two to one to receive either treatment or placebo orally for 14 days. Participants who are randomized in the double-blinded cohort of the study who later progress to severe disease will be offered the option to switch to open-label treatment, as will participants who report persistent severe pain from monkeypox virus infection. Required activities from participants include completing self-skin checks with photographs and symptom diaries.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have an active Monkeypox infection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.