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Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

NCT05597735 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-04-15

No results posted yet for this study

Summary

The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older).

The primary objective is to evaluate the clinical efficacy, as assessed by time to all visible lesion(s) resolution, of tecovirimat treatment + Standard of Care (SOC) compared to placebo + SOC for patients with monkeypox.

The secondary objective is to evaluate the clinical efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms and virological shedding, and the safety of tecovirimat treatment + SOC compared to placebo + SOC in patients with monkeypox.

Conditions

Interventions

DRUG

Tecovirimat

The experimental intervention is tecovirimat, available as immediate-release capsules containing tecovirimat monohydrate, equivalent to 200 mg of tecovirimat. The route of administration of tecovirimat is oral. Tecovirimat treatment will be initiated as soon as possible after diagnosis. The international recommended doses will be followed: * 25 kg to less than 40 kg: 400 mg (two tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days. * 40 kg and above: 600 mg (three tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days.

DRUG

Placebo

The control intervention is a placebo and its route of administration will be identical to the experimental intervention administration to allow treatment arm blinding.

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Fundacion Huesped, Buenos Aires, Argentina

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Yazdan Yazdapanah, Pr. · ANRS, Emerging Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2025-09-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • Argentina
  • Brazil
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597735 on ClinicalTrials.gov