Experimental drug targets smallpox and monkeypox after exposure
NCT ID NCT02080767
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests the drug tecovirimat in people who have been exposed to or infected with orthopox viruses, including smallpox, monkeypox, and cowpox. Participants receive oral tecovirimat to see if it can control the infection and prevent serious complications. The study includes military personnel and affiliated civilians of any age who are not breastfeeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tecovirimat (oral tablet)
- What this could lead to
- If effective, tecovirimat could provide a treatment option for people exposed to dangerous orthopox viruses like smallpox or monkeypox, potentially reducing illness severity and spread.
- What could go wrong
- This is an early-stage protocol with limited data on efficacy in humans. The drug may not work as well in real-world outbreaks, and side effects are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
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.
Inclusion Criteria: * DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding * Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure * Is available for clinical follow-up for duration of the treatment and follow-up period * Must be able to swallow capsules Exclusion Criteria: * Has hypersensitivity to tecovirimat * Unable or unwilling to cooperate with the requirements of the treatment protocol * Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Could a smaller dose of monkeypox vaccine work just as well?