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Mpox drug TPOXX put to the test in 328-Patient trial

NCT ID NCT06721585

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed trial tested the antiviral drug tecovirimat (TPOXX) in 328 adults and children with mpox. Participants received either tecovirimat or a placebo to see if the drug speeds up healing of skin lesions. The study also tracked safety and natural disease progression during the outbreak.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tecovirimat (TPOXX) oral capsules
What this could lead to
If effective, tecovirimat could become a standard treatment to speed up recovery from mpox and reduce symptom duration.
What could go wrong
This is an extension study with no new treatment arm; results may not show clear benefit over placebo. The trial is completed but findings are not yet widely confirmed.

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.

Participants

328 people

The number who actually took part.

Started

Jul 2024

Finished

Aug 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

This study has no age restriction Inclusion Criteria: 1. Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening 2. Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion 3. Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study 4. Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so 5. Severe disease, defined as the presence of at least one of the following: 1. Flat lesions (flat and soft lesions; no pustules or vesicles visible to the eye) 2. Pregnancy (due to risk of serious complication) 3. Suspected sickle cell disease 4. Severe clinical disease, defined as having at least 3 of the following: * Lesion count greater than 250 * Fever for greater than 48 hours * Hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg) * Pallor * Respiratory distress * Altered mental status * Extreme lethargy * Painful oral lesions making oral intake difficult * Difficulty peeing or pooping due to painful lesions * Painful lesions on hands and feet * Tachycardia (heart rate greater than 100 beats per minute) * Diarrhea (greater than or equal to 3 liquid stools per 24 hours) Exclusion Criteria: 1. Severe anemia, defined as hemoglobin less than 7 g/dL 2. Current or planned use of another investigational drug at any point during study participation 3. Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • L'Hôpital Général de Référence de Kole

    Kole, Democratic Republic of the Congo

  • L'Hôpital Général de Référence de Tunda

    Tunda, Democratic Republic of the Congo

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