A5418 MPX-TPOXX Study Supplement

$17,327,975UM1FY2022AINIH

University Of California Los Angeles, Los Angeles CA

Investigators

Linked publications, trials & patents

Paper 39723835 Paper 39704169 Paper 39630590 Paper 39605411 Paper 39477924 Paper 39435321 Paper 39431505 Paper 39401241 Paper 39374532 Paper 39356094 Paper 39287554 Paper 39252866 Paper 39247686 Paper 39209823 Paper 39165724 Paper 39159048 Paper 39135958 Paper 39083151 Paper 39078109 Paper 39074163 Paper 39046173 Paper 39028902 Paper 39012226 Paper 38983711 Paper 38961547 Paper 38938873 Paper 38923420 Paper 38746756 Paper 38746144 Paper 38739755 Paper 38716969 Paper 38692296 Paper 38684100 Paper 38659142 Paper 38645191 Paper 38635853 Paper 38606559 Paper 38597667 Paper 38568956 Paper 38564365 Paper 38556761 Paper 38551350 Paper 38533953 Paper 38489580 Paper 38408216 Paper 38372621 Paper 38372392 Paper 38332460 Paper 38329130 Paper 38293205 Paper 38253253 Paper 38236978 Paper 38180893 Paper 38175824 Paper 38160309 Paper 38147306 Paper 38112526 Paper 38051788 Paper 38034739 Paper 38006017 Paper 37999615 Paper 37971239 Paper 37957382 Paper 37947968 Paper 37936652 Paper 37920110 Paper 37910437 Paper 37855026 Paper 37820116 Paper 37745410 Paper 37744732 Paper 37744358 Paper 37696248 Trial NCT06856174 Trial NCT06205602 Trial NCT06205589 Trial NCT06031272 Trial NCT05985642 Trial NCT05654051 Trial NCT05156658 Trial NCT04636437 Trial NCT04050449 Trial NCT04042740 Trial NCT03819114 Trial NCT03512210 Trial NCT03070223 Trial NCT03001128 Trial NCT02859558 Trial NCT02605304 Trial NCT02582684 Trial NCT02513771 Trial NCT02440789 Trial NCT02412436 Trial NCT02411539 Trial NCT02155985 Trial NCT02128217 Trial NCT01969058 Trial NCT01936831 Trial NCT01928927 Trial NCT01903031

Abstract

Abstract This supplement will support A5418. A5418 is Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV). The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and breastfeeding individuals, individuals less than 18 years of age, people with severe immune suppression or skin conditions placing them at higher risk for severe disease. The primary endpoint is the time to clinical resolution defined as all skin lesions are either scabbed, desquamated or healed and all visible mucosal lesions healed.

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