A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox (mpox) Virus Disease

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Brief Description:  

Since Spring of 2022, mpox has rapidly spread throughout the world, with more than 70,000 cases in 107 countries. As of September 2022, more than 26,000 cases have been reported in the United States.  

Tecovirimat is a drug that is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children. It is not known if Tecovirimat is effective in people with mpox. 

Purpose of study:  

We are doing this study to see if tecovirimat helps people with mpox heal faster.  

Major requirements for entering the study (things that must be true for you): 

  • Laboratory-confirmed or presumptive mpox infection 

  • Monkeypox illness of less than 14 days (about 2 weeks) duration  

  • At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis (inflammation of the lining of the rectum) with or without visible ulcers 

Intervention:  

The study-provided treatment is Tecovirimat or Placebo for Tecovirimat.  

Most people will be randomly assigned (like flipping a coin or rolling dice) to a study group. Twice as many people will receive Tecovirimat than the placebo in this study. So, you are twice as likely to receive the drug Tecovirimat.  

Some people with severe disease will receive Tecovirimat with no possibility of placebo. Other people who receive Tecovirimat with no possibility of placebo include: 

  • Pregnant or breastfeeding individuals 

  • Minors 

  • People with severe immune suppression or skin conditions placing them at higher risk for severe mpox 

Duration of Study:  

You will be in this study for about two months (60 days). 

You have the option to participate in this study through in person visits or remote visits (such as video visits). 

Contact information:  

Clinical Research Coordinator: Veronica Viar  

Email: [email protected]  

Phone number: 415-806-8554