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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Ginevra, Zurigo
(BASEC)
Sponsor
Sponsor : INSERM | ANRS-MIE Sponsor representative in Switzerland: Hôpitaux Universitaires de Genève, Prof. Alexandra Calmy
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Alexandra Calmy
+41223729812
alexandra.calmy@clutterhcuge.chHôpitaux Universitaires de Genève
(BASEC)
Informazioni generali
ANRS, Emerging Infectious Diseases,
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Informazioni generali
ANRS, Emerging Infectious Diseases
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Informazioni scientifiche
ANRS, Emerging Infectious Diseases,
0182533538
alexandra.calmy@clutterhcuge.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
21.11.2022
(BASEC)
ID di studio ICTRP
NCT05597735 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease (ICTRP)
Malattie studiate
MonkeypoxMpox (ICTRP)
Intervento studiato
Drug: TecovirimatDrug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
27.10.2022 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University Hospital, Geneva;Oswaldo Cruz Foundation;Fundacion Huesped, Buenos Aires, Argentina (ICTRP)
Contatti aggiuntivi
Yazdan Yazdapanah, Pr.;Michele GENIN, PhD, michele.genin@inserm.fr, 0182533538, ANRS, Emerging Infectious Diseases, (ICTRP)
ID secondari
2022-01579 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05597735 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile