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Can a pill speed up monkeypox recovery? major trial underway

NCT ID NCT05597735

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the antiviral drug tecovirimat can help people with monkeypox heal faster. About 480 adults and teens (14+) with active lesions will receive either tecovirimat or a placebo, alongside standard care. The main goal is to see how quickly skin and mouth sores clear up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

monkeypox

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Monkeypox Mpox

Contacts and locations

Locations

  • CHUV

    Lausanne, Canton of Vaud, 1010, Switzerland

  • Emílio Ribas Institute of Infectious Diseases

    São Paulo, Brazil

  • Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation-FIOCRUZ

    Rio de Janeiro, Brazil

  • Faculty of Medicine, Federal University of Minas Gerais

    Belo Horizonte, Brazil

  • Federal Hospital for State Employees

    Rio de Janeiro, Brazil

  • Fundación Huésped

    Buenos Aires, C1204ABB, Argentina

  • Hôpitaux Universitaires de Genève

    Geneva, Canton of Geneva, 1211, Switzerland

  • Nova Iguaçu General Hospital

    Rio de Janeiro, Brazil

  • Pr Alexandra Calmy

    Geneva, Canton of Geneva, 1211, Switzerland

  • STD/AIDS Reference and Training Center

    São Paulo, Brazil

  • University Hospital Prof. Edgard Santos

    Salvador, Brazil

  • Zürich checkpoint

    Zurich, Canton of Zurich, Switzerland

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