Phase
Condition
N/ATreatment
Tecovirimat Oral Capsule
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmedmpox infection
The presence of active skin or mucosal lesion(s)
Signed Informed Consent Form
Exclusion
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 thestudy drug.
Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment fordiabetes mellitus, may be discontinued while taking study treatment with theagreement of the patient's general practitioner, who may start alternate diabetestreatment if considered necessary.)
Previous, current or planned use of another investigational drug (tecovirimat) atany point during study participation.
The patient's own doctor considers there to be a definite indication for the patientto receive tecovirimat or the local guidelines establish that tecovirimat treatmentshould be initiated
The patient's own doctor considers there to be a definite contraindication to thepatient receiving tecovirimat.
The patient suffers from hereditary problems of galactose intolerance, Lapp lactasedeficiency or glucose-galactose malabsorption.
Study Design
Connect with a study center
Institute of Tropical Medicine
Antwerp, 2000
BelgiumActive - Recruiting
Cliniques Universitaires St. Luc
Brussels, 1200
BelgiumSite Not Available
APHP St. Louis
Paris, 75010
FranceSite Not Available
Universitätsklinikum Bonn
Bonn, 53127
GermanySite Not Available
Hospital Luigi Sacco
Milan,
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona
Verona,
ItalySite Not Available
Amsterdam UMC - AMC
Amsterdam,
NetherlandsSite Not Available
Oslo Unversity Hospital
Oslo, 0450
NorwaySite Not Available
Hospital de Santo António dos Capuchos
Lisbon, 1169-050
PortugalSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainSite Not Available
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