Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

Summary

The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older). The primary objective is to evaluate the clinical efficacy, as assessed by time to all visible lesion(s) resolution, of tecovirimat treatment + Standard of Care (SOC) compared to placebo + SOC for patients with monkeypox. The secondary objective is to evaluate the clinical efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms and virological shedding, and the safety of tecovirimat treatment + SOC compared to placebo + SOC in patients with monkeypox.

Timeline

Start

2023-03-03

Primary completion

2026-09-30

Completion

2026-09-30

Publications

• Background Thornhill JP, Barkati S, Walmsley S, Rockstroh J, Antinori A, Harrison LB, Palich R, Nori A, Reeves I, Habibi MS, Apea V, Boesecke C, Vandekerckhove L, Yakubovsky M, Sendagorta E, Blanco JL, Florence E, Moschese D, Maltez FM, Goorhuis A, Pourcher V, Migaud P, Noe S, Pintado C, Maggi F, Hansen AE, Hoffmann C, Lezama JI, Mussini C, Cattelan A, Makofane K, Tan D, Nozza S, Nemeth J, Klein MB, Orkin CM; SHARE-net Clinical Group. Monkeypox Virus Infection in Humans across 16 Countries - April-June 2022. N Engl J Med. 2022 Aug 25;387(8):679-691. doi: 10.1056/NEJMoa2207323. Epub 2022 Jul 21.
• Background Girometti N, Byrne R, Bracchi M, Heskin J, McOwan A, Tittle V, Gedela K, Scott C, Patel S, Gohil J, Nugent D, Suchak T, Dickinson M, Feeney M, Mora-Peris B, Stegmann K, Plaha K, Davies G, Moore LSP, Mughal N, Asboe D, Boffito M, Jones R, Whitlock G. Demographic and clinical characteristics of confirmed human monkeypox virus cases in individuals attending a sexual health centre in London, UK: an observational analysis. Lancet Infect Dis. 2022 Sep;22(9):1321-1328. doi: 10.1016/S1473-3099(22)00411-X. Epub 2022 Jul 1.
• Background Siegrist EA, Sassine J. Antivirals With Activity Against Mpox: A Clinically Oriented Review. Clin Infect Dis. 2023 Jan 6;76(1):155-164. doi: 10.1093/cid/ciac622.
• Background Smith SK, Self J, Weiss S, Carroll D, Braden Z, Regnery RL, Davidson W, Jordan R, Hruby DE, Damon IK. Effective antiviral treatment of systemic orthopoxvirus disease: ST-246 treatment of prairie dogs infected with monkeypox virus. J Virol. 2011 Sep;85(17):9176-87. doi: 10.1128/JVI.02173-10. Epub 2011 Jun 22.
• Background O'Laughlin K, Tobolowsky FA, Elmor R, Overton R, O'Connor SM, Damon IK, Petersen BW, Rao AK, Chatham-Stephens K, Yu P, Yu Y; CDC Monkeypox Tecovirimat Data Abstraction Team. Clinical Use of Tecovirimat (Tpoxx) for Treatment of Monkeypox Under an Investigational New Drug Protocol - United States, May-August 2022. MMWR Morb Mortal Wkly Rep. 2022 Sep 16;71(37):1190-1195. doi: 10.15585/mmwr.mm7137e1.
• Background Desai AN, Thompson GR 3rd, Neumeister SM, Arutyunova AM, Trigg K, Cohen SH. Compassionate Use of Tecovirimat for the Treatment of Monkeypox Infection. JAMA. 2022 Oct 4;328(13):1348-1350. doi: 10.1001/jama.2022.15336.
• Background Adler H, Gould S, Hine P, Snell LB, Wong W, Houlihan CF, Osborne JC, Rampling T, Beadsworth MB, Duncan CJ, Dunning J, Fletcher TE, Hunter ER, Jacobs M, Khoo SH, Newsholme W, Porter D, Porter RJ, Ratcliffe L, Schmid ML, Semple MG, Tunbridge AJ, Wingfield T, Price NM; NHS England High Consequence Infectious Diseases (Airborne) Network. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis. 2022 Aug;22(8):1153-1162. doi: 10.1016/S1473-3099(22)00228-6. Epub 2022 May 24.
• Background Carvalho T. The unknown efficacy of tecovirimat against monkeypox. Nat Med. 2022 Nov;28(11):2224-2225. doi: 10.1038/d41591-022-00094-0. No abstract available.
• Background Merchlinsky M, Albright A, Olson V, Schiltz H, Merkeley T, Hughes C, Petersen B, Challberg M. The development and approval of tecoviromat (TPOXX(R)), the first antiviral against smallpox. Antiviral Res. 2019 Aug;168:168-174. doi: 10.1016/j.antiviral.2019.06.005. Epub 2019 Jun 7.

Drugs

Indications