Mpox drug TPOXX put to the test in 328-Patient trial
NCT ID NCT06721585
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
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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L'Hôpital Général de Référence de Tunda
Tunda, Democratic Republic of the Congo
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