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Monkeypox drug trial: can tecovirimat speed up healing?

NCT ID NCT05559099

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug tecovirimat is safe and effective for treating monkeypox (mpox). About 600 adults and children with confirmed mpox and active skin lesions took either tecovirimat or a placebo for 14 days, along with standard care. The main goal was to see how quickly their lesions healed. The trial is now complete.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

597 people

The number who actually took part.

Started

Oct 2022

Finished

Sep 2024

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.

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: * Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening * Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion * Weight ≥3 kg * Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following: * Hormonal contraception * Male or female condom * Diaphragm or cervical cap with a spermicide * Intrauterine device * Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study * Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so Exclusion Criteria: * Current or planned use of a meglitinide (repaglinide, nateglinide) * Planned use of midazolam while on study drug * Severe anemia, defined as hemoglobin \<7 g/dL * Current or planned use of another investigational drug at any point during study participation * Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study * Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration

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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

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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