Clinical features and management of human monkeypox: a retrospective observational study in the UK.
Hugh Adler, Susan Gould, Paul Hine...
https://pubmed.ncbi.nlm.nih.gov/35623380Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06156566
European Randomised Clinical Trial on mPOX Infection
Led by Miquel Ekkelenkamp · Updated on 2025-03-28
150
Participants Needed
12
Research Sites
34 weeks
Total Duration
On this page
Sponsors
M
Miquel Ekkelenkamp
Lead Sponsor
E
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the drug tecovirimat in adults with mpox infection, also known as monkeypox, in this randomized controlled double-blind clinical trial. The study aims to determine if tecovirimat is effective and safe for treating mpox. Participants must have confirmed mpox infection with active skin or mucosal lesions to join the trial. Participants will be randomly assigned to receive either oral tecovirimat capsules or a matching placebo. The tecovirimat group will take 600 mg twice daily (three 200 mg capsules each dose) for 14 days, totaling 28 doses. The placebo group will follow the same schedule with identical capsules but without the active drug. During the study, researchers will closely monitor participants' mpox lesions, symptoms, and overall condition. They will assess the time it takes for lesions to fully heal within 28 days, symptom resolution up to 90 days, and any side effects or complications. Other outcomes include quality of life changes, virus clearance from skin or mucosal swabs, and hospital admissions. Safety will be evaluated throughout the trial, which lasts up to 90 days after treatment starts.
CONDITIONS
Brief Title
European Trial Into Mpox Infection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Polymerase Chain Reaction (PCR) or Nucleic Acid Amplification Test (NAAT) confirmed mpox infection
- Presence of active skin or mucosal lesion(s)
- Signed informed consent form
You will not qualify if you...
- Age under 18 years
- Body weight less than 40 kg
- Pregnant or breastfeeding patients
- Lack of mental capacity to provide informed consent
- Participation not in the patient's best interest
- Known allergy to the study drug or its ingredients
- Use of repaglinide without agreement from general practitioner
- Previous, current, or planned use of investigational tecovirimat
- Doctor's recommendation for or against tecovirimat treatment
- Hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 14 days
Participants take oral capsules of either tecovirimat or placebo twice daily for 14 days to treat mpox infection.
Twice daily dosing for 14 days
Follow-up
Duration - Up to 90 days
Participants are monitored after treatment to assess lesion resolution, symptom improvement, and safety outcomes.
Visits on days 7, 14, 28, and 90
Trial Site Locations
Total: 12 locations
1
Institute of Tropical Medicine
Antwerp, Antwerp, Belgium, 2000
Actively Recruiting
2
Cliniques Universitaires St. Luc
Brussels, Belgium, 1200
Not Yet Recruiting
3
APHP St. Louis
Paris, France, 75010
Not Yet Recruiting
4
Universitätsklinikum Bonn
Bonn, Germany, 53127
Not Yet Recruiting
5
Hospital Luigi Sacco
Milan, Italy
Not Yet Recruiting
6
Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona
Verona, Italy
Not Yet Recruiting
7
Amsterdam UMC - AMC
Amsterdam, Netherlands
Not Yet Recruiting
8
Oslo Unversity Hospital
Oslo, Norway, 0450
Not Yet Recruiting
9
Hospital de Santo António dos Capuchos
Lisbon, Portugal, 1169-050
Not Yet Recruiting
10
Hospital Clinico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
11
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
12
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Not Yet Recruiting
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Research Team
M
Miquel B Ekkelenkamp, MD, PhD
L
Lina Gurskaite
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical features, hospitalisation and deaths associated with monkeypox: a systematic review and meta-analysis.
Vicente A Benites-Zapata, Juan R Ulloque-Badaracco, Esteban A Alarcon-Braga...
https://pubmed.ncbi.nlm.nih.gov/35948973The changing epidemiology of human monkeypox-A potential threat? A systematic review.
Eveline M Bunge, Bernard Hoet, Liddy Chen...
https://pubmed.ncbi.nlm.nih.gov/35148313Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions.
Jack E Burkhalter, Thomas M Atkinson, J Berry-Lawhorn...
https://pubmed.ncbi.nlm.nih.gov/30098677Drug Development against Smallpox: Present and Future.
Déborah Delaune, Frédéric Iseni
https://pubmed.ncbi.nlm.nih.gov/31932370Oral Tecovirimat for the Treatment of Smallpox.
Douglas W Grosenbach, Kady Honeychurch, Eric A Rose...
https://pubmed.ncbi.nlm.nih.gov/29972742Orthopoxvirus genome evolution: the role of gene loss.
Robert Curtis Hendrickson, Chunlin Wang, Eneida L Hatcher...
https://pubmed.ncbi.nlm.nih.gov/21994715Tecovirimat: First Global Approval.
Sheridan M Hoy
https://pubmed.ncbi.nlm.nih.gov/30120738A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes.
George Howard, Jennifer L Waller, Jenifer H Voeks...
https://pubmed.ncbi.nlm.nih.gov/22343650Serological survey for human monkeypox infections in a selected population in Zaire.
Z Jezek, J H Nakano, I Arita...
https://pubmed.ncbi.nlm.nih.gov/3029395