Phase III, randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of antiviral treatment with tecovirimat in patients with monkeypox (UNITY study)
Résumé de l'étude
Monkeypox is a disease caused by the monkeypox virus (MPXV), which has been spreading rapidly in Europe since May 2022. There is only one antiviral drug approved in the European Union (EU) for the treatment of monkeypox, and no treatment is yet approved in Switzerland. This drug is tecovirimat (TPOXX®). As this disease is rare, the efficacy and safety of tecovirimat have primarily been evaluated in animals and healthy volunteers. This study aims to gather more information on the efficacy and safety of this drug in patients with monkeypox. To determine if tecovirimat (the experimental product) is effective, we will compare it to a product that does not contain an active compound, meaning some people participating in the study will receive a "placebo". The placebo looks like the experimental product but contains no active substance, only inactive ingredients. Of two people participating in this study, one will receive the experimental product and the other the placebo. The participant and the study staff will not know whether the participant is receiving the experimental product or the placebo. This study will include adults and adolescents (aged 14 years and older).
(BASEC)
Intervention étudiée
The experimental product (tecovirimat) or the placebo will be taken two or three times a day (depending on the participant's weight), every day for 14 consecutive days.
The intake will be oral.
In addition to receiving tecovirimat or placebo, all participants will receive routine care ("standard of care").
(BASEC)
Maladie en cours d'investigation
Monkeypox (monkeypox - mpox)
(BASEC)
- Adults and adolescents (aged 14 years and older) with laboratory-confirmed monkeypox (PCR if available) or with a strong suspicion of infection, of any duration - At least one visible active lesion of the skin or mucous membrane - Reachable via smartphone (for video calls) for outpatient participants - Signed informed consent (BASEC)
Critères d'exclusion
- Current or planned use of another experimental drug at any time during participation in the study - Patients who, in the opinion of the investigator, will be at significantly increased risk by participating in the study (e.g.: if the investigator believes that antiviral treatment is not indicated) - Hypersensitivity to tecovirimat (BASEC)
Lieu de l’étude
Genève, Zurich
(BASEC)
Sponsor
Sponsor : INSERM | ANRS-MIE Sponsor representative in Switzerland: Hôpitaux Universitaires de Genève, Prof. Alexandra Calmy
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Alexandra Calmy
+41223729812
alexandra.calmy@clutterhcuge.chHôpitaux Universitaires de Genève
(BASEC)
Informations générales
ANRS, Emerging Infectious Diseases,
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Informations générales
ANRS, Emerging Infectious Diseases
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Informations scientifiques
ANRS, Emerging Infectious Diseases,
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
21.11.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05597735 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A phase III, multi-country, randomized, placebo-controlled, double-blinded trial to assess the efficacy and safety of tecovirimat antiviral treatment for patients with mpox virus disease The UNITY Study (BASEC)
Titre académique
A Phase III, Multi-country, Randomized, Placebo-controlled, Double-blinded Trial to Assess the Efficacy and Safety of Tecovirimat Antiviral Treatment for Patients With Monkeypox Virus Disease (ICTRP)
Titre public
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease (ICTRP)
Maladie en cours d'investigation
MonkeypoxMpox (ICTRP)
Intervention étudiée
Drug: TecovirimatDrug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Adults and adolescents (14 years old and older) with laboratory-confirmed (PCR if
available) or highly suspected monkeypox virus infection of any duration
- At least one visible active skin or mucosal lesion
- Reachable via smartphone (for video calls) for outpatient participants
- Signed informed consent
Exclusion Criteria:
- Current or planned use of another investigational drug at any point during study
participation.
- Ongoing treatment which cannot be interrupted and for which a major interaction has
been described with tecovirimat
- Patients who, in the judgement of the investigator, will be at significantly
increased risk as a result of participation in the study (for example: if the
investigator judges that an antiviral treatment is indicated in the framework of
compassionate therapeutic access in Switzerland).
- Hypersensitivity to tecovirimat (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Time to all visible lesion(s) resolution (ICTRP)
All-cause mortality within the first 28 days (applied to all patients);All-cause unplanned admission to hospital within first 28 days (applies to outpatients);Occurrence of patients with a complication within first 28 days (applies to all patients who did not already have a complication at baseline);Time to resolution of symptoms and signs within first 28 days (applies to all patients);Viral clearance up to 28 days after randomization;Frequency of adverse events (AEs) and serious adverse events (SAEs) for specific therapeutics (applies to all patients) (ICTRP)
Date d'enregistrement
27.10.2022 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
University Hospital, Geneva;Oswaldo Cruz Foundation;Fundacion Huesped, Buenos Aires, Argentina (ICTRP)
Contacts supplémentaires
Yazdan Yazdapanah, Pr.;Michele GENIN, PhD, michele.genin@inserm.fr, 0182533538, ANRS, Emerging Infectious Diseases, (ICTRP)
ID secondaires
2022-01579 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05597735 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible