NIAID's STOMP Trial Evaluates Tecovirimat for Mpox Treatment

Key Insights

• The NIAID-funded STOMP trial is evaluating the efficacy of tecovirimat (TPOXX) for treating mpox in adults and children, addressing a critical need for effective therapies.
• The trial employs a double-blind, placebo-controlled design for adult participants, with an open-label arm for those with severe mpox, immunodeficiency, or other specific conditions.
• Participants will be monitored for lesion healing, pain reduction, and symptom resolution over 57 days, with data collected through symptom diaries, skin checks, and clinic visits.

The National Institute of Allergy and Infectious Diseases (NIAID) is conducting a clinical trial, known as STOMP (Study of Tecovirimat for Human Mpox Virus), to assess the effectiveness of tecovirimat, also known as TPOXX, in treating mpox. The trial aims to determine if tecovirimat can expedite healing and alleviate pain associated with mpox infection.

The STOMP trial is enrolling adults and children with mpox across various clinical research sites. A cohort of 530 adult participants will be randomly assigned in a 2:1 ratio to receive either tecovirimat or a placebo for 14 days. This portion of the study is double-blinded, ensuring neither the participants nor the investigators are aware of the treatment assignments. Additionally, an open-label arm will enroll individuals with severe mpox, significant immunodeficiency, severe inflammatory skin conditions, those on medications affecting tecovirimat levels, pregnant or breastfeeding individuals, and children, all of whom will receive tecovirimat.

Trial Design and Endpoints

Participants will be monitored for at least 57 days, during which they will complete symptom diaries, perform daily skin checks, and attend virtual and in-person clinic appointments. Researchers will collect data on lesion healing rates, pain levels, and overall symptom resolution. The trial involves physical examinations and the collection of blood and bodily fluid samples, including lesion swabs.

Accessibility and Enrollment

To enhance participation, the STOMP trial offers remote enrollment, allowing volunteers from anywhere in the United States to join. Interested individuals can find more information and enroll through the STOMP website.

Who Can Participate

Both adults and children of any age who have been diagnosed with mpox are eligible to participate in the STOMP trial. There is no cost to participate, removing a potential barrier to enrollment.

The STOMP trial represents a crucial step in identifying effective treatments for mpox and improving patient outcomes. The results of this study will provide valuable insights into the role of tecovirimat in managing mpox infections.