According to a Study of Tecovirimat for Mpox (STOMP) analysis, “tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease.”
A release on the study from the National Institutes of health said “there were no safety concerns associated with tecovirimat.” The study’s Data Safety and Monitoring Board (DSMB) suggested halting study enrollment of participants who were being randomized to tecovirimat or placebo. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) accepted.
The NIH said, “given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug’s efficacy.”
Additionally, “At the DSMB’s request, an additional assessment was performed and showed that there was a less than 1% chance that the study would show tecovirimat to be effective if it were to complete enrollment and follow-up, based on the study design and available data. At the time of analysis, reported adverse events were low and comparable between tecovirimat and placebo. By design, the open-label study arm did not assign participants to receive a placebo, so STOMP will not draw conclusions about the efficacy of tecovirimat in participants with, or at elevated risk for, severe clade II mpox.”
