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Recruiting NCT06156566

European Trial Into Mpox Infection

Phase IV Interventional Monkeypox

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tecovirimat Oral Capsule, Placebo.
Who it may be relevant to
Registry conditions: Monkeypox. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France, Germany, Italy, Netherlands +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

European Randomised Clinical Trial on mPOX Infection

Overview

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.

Interventions

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

Primary outcome measures

  • Time to complete mpox lesion resolution [Time frame: 28 days]
Secondary outcome measures (10)
  • Time to active lesion resolution [Time frame: 28 days]
  • Status of the lesions on day 7, 14 and 28 [Time frame: Day 7, day 14 and day 28]
  • Time to resolution of symptoms [Time frame: 90 days]
  • Occurrence of a negative monkeypox PCR of skin or mucosal swab [Time frame: Days 7, 14 and 28]
  • Persistence of scars and skin discoloration [Time frame: Assessed on day 90]
  • Change from baseline in quality of life [Time frame: Assessed on day 14 and day 90.]
  • All-cause mortality [Time frame: Assessed on day 28 and on day 90]
  • Time to complication or all-cause admission to hospital or all-cause death [Time frame: Assessed within 28 days and within 90 days.]
  • Frequency of AEs, SAEs and SUSARs [Time frame: Assessed within 28 days and within 90 days.]
  • Resolution of pain [Time frame: Assessed on days 7, 14 and 90.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Spain · 3 centers
  • Hospital Clinico San Carlos — Madrid
  • Hospital Universitario La Paz — Madrid
  • Hospital Universitario Virgen Macarena — Seville
Belgium · 2 centers
  • Institute of Tropical Medicine — Antwerp
  • Cliniques Universitaires St. Luc — Brussels
Italy · 2 centers
  • Hospital Luigi Sacco — Milan
  • Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona — Verona
France · 1 center
  • APHP St. Louis — Paris
Germany · 1 center
  • Universitätsklinikum Bonn — Bonn
Netherlands · 1 center
  • Amsterdam UMC - AMC — Amsterdam
Norway · 1 center
  • Oslo Unversity Hospital — Oslo
Portugal · 1 center
  • Hospital de Santo António dos Capuchos — Lisbon

Publications

  • 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

Identifiers

NCT: NCT06156566 · 2022-501979-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗