CTN 338: PLATINUM-CAN

About the Study

CTN 338 is a clinical trial to evaluate the effectiveness and safety of tecovirimat (TPOXX) for the treatment of Mpox infection compared to placebo. TPOXX is an antiviral medication developed to treat smallpox, but it may also be effective for Mpox as the viruses are closely related. The study is also collecting information about the feasibility and acceptability of conducting this type of trial for non-hospitalized patients with Mpox in Canada.

Background

Mpox is a DNA virus that is in the same family as smallpox. In the past, it has occurred primarily in Central and West Africa. However, since the middle of May 2022, more Mpox cases have been reported across the world, including in Canada. Men who have sex with men have been particularly affected during the recent outbreak where the virus is being transmitted sexually. In general, symptoms start about one to three weeks after exposure and include fever and swollen lymph nodes and painful skin lesions that usually last two to four weeks. Lesions often occur in the rectum, genitals, and mouth. These symptoms can cause considerable pain and discomfort and may require people to isolate until their lesions heal.

Even though Mpox was identified several decades ago, we do not have any effective treatments for it. Oral TPOXX is approved by Health Canada for the treatment of smallpox. Laboratory studies suggest that it may be active against Mpox. However, in Canada, TPOXX is only available for use in severe and hospitalized Mpox cases. We dont know if TPOXX can speed the time to recovery or reduce symptoms for people with more mild disease. While there is a vaccine available to prevent Mpox, we do not know how effective it is or how long protection lasts. It is therefore important that we conduct studies and learn more about Mpox infection to reduce the impact of this virus for people in Canada and beyond.