European Trial Into Mpox Infection

Официальное название

European Randomised Clinical Trial on mPOX Infection

Обзор

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease. The main questions it aims to answer are: * Is tecovirimat effective in treating mpox infection. * Is tecovirimat safe to treat patients with mpox infection. Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.

Вмешательства

• Препарат Tecovirimat Oral Capsule
  600 mg, twice daily, 14 days.
• Препарат Placebo
  3 capsules, twice daily, 14 days.

Первичные конечные точки

• Time to complete mpox lesion resolution [Срок оценки: 28 days]

Вторичные конечные точки (10)

• Time to active lesion resolution [Срок оценки: 28 days]
• Status of the lesions on day 7, 14 and 28 [Срок оценки: Day 7, day 14 and day 28]
• Time to resolution of symptoms [Срок оценки: 90 days]
• Occurrence of a negative monkeypox PCR of skin or mucosal swab [Срок оценки: Days 7, 14 and 28]
• Persistence of scars and skin discoloration [Срок оценки: Assessed on day 90]
• Change from baseline in quality of life [Срок оценки: Assessed on day 14 and day 90.]
• All-cause mortality [Срок оценки: Assessed on day 28 and on day 90]
• Time to complication or all-cause admission to hospital or all-cause death [Срок оценки: Assessed within 28 days and within 90 days.]
• Frequency of AEs, SAEs and SUSARs [Срок оценки: Assessed within 28 days and within 90 days.]
• Resolution of pain [Срок оценки: Assessed on days 7, 14 and 90.]

Критерии участия

Критерии включения

• Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
• The presence of active skin or mucosal lesion(s)
• Signed Informed Consent Form

Критерии исключения

• Age <18 years.
• Body weight <40 kg
• Pregnant and breastfeeding patients are not eligible for inclusion in this study.
• Lack of mental capacity to provide informed consent
• Trial participation is considered not in the best interest of patient
• Known hypersensitivity to the active substance or to any of the excipients of the study drug.
• Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
• Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
• The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
• The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
• The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 3 центра

• Hospital Clinico San Carlos — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Virgen Macarena — Seville

Бельгия · 2 центра

• Institute of Tropical Medicine — Antwerp
• Cliniques Universitaires St. Luc — Brussels

Италия · 2 центра

• Hospital Luigi Sacco — Milan
• Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona — Verona

Франция · 1 центр

• APHP St. Louis — Paris

Германия · 1 центр

• Universitätsklinikum Bonn — Bonn

Нидерланды · 1 центр

• Amsterdam UMC - AMC — Amsterdam

Норвегия · 1 центр

• Oslo Unversity Hospital — Oslo

Португалия · 1 центр

• Hospital de Santo António dos Capuchos — Lisbon

Публикации

• 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 retrospec PMID 35623380
• Benites-Zapata VA, Ulloque-Badaracco JR, Alarcon-Braga EA, Hernandez-Bustamante EA, Mosquera-Rojas MD, Bonilla-Aldana DK, Rodriguez-Morales AJ. Clinical features, hospitalisation and deaths associated with monkeypox: a systematic review and meta-analysis. Ann Clin Microbiol Antimicrob. 2022 Aug 10;21(1):36. doi: 10.1186/s12941-022-00527-1. PMID 35948973
• Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Statist Soc B 1995;57(1):289-300.
• Bunge EM, Hoet B, Chen L, Lienert F, Weidenthaler H, Baer LR, Steffen R. The changing epidemiology of human monkeypox-A potential threat? A systematic review. PLoS Negl Trop Dis. 2022 Feb 11;16(2):e0010141. doi: 10.1371/journal.pntd.0010141. eCollection 2022 Feb. PMID 35148313
• Burkhalter JE, Atkinson TM, Berry-Lawhorn J, Goldstone S, Einstein MH, Wilkin TJ, Lee J, Cella D, Palefsky JM; ANCHOR HRQOL Implementation Group. Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions. Value Health. 2018 Aug;21(8):984-992. doi: 10.1016/j.jval.2018.01.018. Epub 2018 Ap PMID 30098677
• Delaune D, Iseni F. Drug Development against Smallpox: Present and Future. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e01683-19. doi: 10.1128/AAC.01683-19. Print 2020 Mar 24. PMID 31932370
• EMA: An overview of Tecovirimat SIGA and why it is authorised in the EU. 31-May-2022: https://www.ema.europa.eu/en/documents/overview/tecovirimat-siga-epar-medicine-overview_en.pdf
• EMA: Summary of product characteristics: www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf, accessed 6-9-2022

Идентификаторы

NCT: NCT06156566 · 2022-501979-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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