Tecovirimat Trial for the Treatment of Human Monkeypox Virus Disease

STUDY BASICS

Do you currently have the monkeypox virus and at least one unscabbed lesion? You may be able to participate in a research study evaluating how well tecovirimat works for the treatment of human monkeypox virus infection. Compensation is provided.

STUDY PURPOSE

Monkeypox is caused by a virus. This virus is most often spread by close contact with someone who has monkeypox. Illness caused by monkeypox virus infection usually starts with a fever and feeling poorly before a rash begins. The rash looks like raised bumps and pus-filled blisters (called lesions). The lesions then crust, scab, and fall off after about 2-4 weeks. 

Tecovirimat is a drug that may help to treat infections caused by monkeypox viruses. Tecovirimat is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children, but its use in this study is considered investigational. This study aims to see if tecovirimat is safe and whether it helps treat monkeypox in people. This study will also help us understand more about how human monkeypox causes disease and how the body fights off infection with monkeypox. 

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 18 or older
• You are known to have monkeypox virus or your healthcare providers suspect you have monkeypox virus 
• You have had symptoms for fewer than 14 days 
• You have at least one active, not yet scabbed lesion, or proctitis (inflammation of the lining of the rectum) or mouth sores 

WHAT PARTICIPANTS CAN EXPECT

If eligible, you will be required to: 

• have physical exams 
• record symptoms daily 
• provide blood and urine samples
• provide (or a study member will obtain) swabs of the sores on your skin, mouth, vagina and rectum 
• complete questionnaires about your symptoms