Tecovirimat for Treatment of Monkeypox Virus

Summary

The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.

Timeline

Start

2022-10-10

Primary completion

2024-09-03

Completion

2024-09-03

Outcome

Missed primary endpoint

paper The competing-risks hazard ratio for lesion resolution was 1.13 (95% confidence interval [CI], 0.97 to 1.31; P = 0.14). PMID 40239067 ↗

paper Tecovirimat did not reduce the number of days to lesion resolution in patients with mpox caused by clade I MPXV. PMID 40239067 ↗

Publications

• PALM007 Writing Group; Ali R, Alonga J, Biampata JL, Kombozi Basika M, Maljkovic Berry I, Bisento N, Blum E, Bonnett T, Cone K, Crozier I, Davey R, Dilu A, Dodd LE, Gulati I, Hruby D, Ibanda A, Isse F, Kasareka SS, Kayembe G, Kojan R, Luzolo EK, Lane HC, Lawanga L, Liesenborghs L, Shosongo Lunghe C, Lula Y, Lusakibanza M, Lutete GT, Mbala-Kingebeni P, Miranda A, Mukadi-Bamuleka D, Mukendi G, Lupola PM, Muyembe-Tamfum JJ, Ndungunu R, Nganga B, Ntamabyaliro N, Nussenblatt V, Omulepu I, Omalokoho Onosomba J, Proschan M, Rubenstein K, Saknite I, Schechner A, Shaw-Saliba K, Sivahera B, Smolskis M, Tillman A, Tkaczyk E, Tshimanga C, Tshiani Mbaya O, Tshomba A, Yemba Unda Tshomba F, Vallee D, Vogel S, Weyers S. Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo. N Engl J Med. 2025 Apr 17;392(15):1484-1496. doi: 10.1056/NEJMoa2412439.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tecovirimat	Small molecule	100 mg	—
Subject	Tecovirimat	Small molecule	200 mg	—
Subject	Tecovirimat	Small molecule	400 mg	—
Subject	Tecovirimat	Small molecule	800 mg	—
Subject	Tecovirimat	Small molecule	1200 mg	—
Subject	Tecovirimat	Small molecule	1800 mg	—

Indications