'Re­al­ly in­clude every­one in the tri­al': A Q&A with the pro­to­col chair of the PhI­II mon­key­pox an­tivi­ral study

On Sept. 8, the AIDS Clin­i­cal Tri­als Group and the Na­tion­al In­sti­tutes of Health be­gan a Phase III clin­i­cal tri­al of tecovir­i­mat, an an­tivi­ral ap­proved by the FDA for small­pox. The place­bo-con­trolled study will look at the ef­fi­ca­cy of the drug in re­duc­ing le­sions and could serve as the ba­sis for an ex­pand­ed la­bel of the an­tivi­ral.

The US gov­ern­ment has more than 1 mil­lion dos­es of the drug in its strate­gic na­tion­al stock­pile and the CDC has opened its use via an ex­pand­ed ac­cess pro­gram dur­ing the mon­key­pox out­break this sum­mer.

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