Experimental drug targets smallpox and monkeypox after exposure

NCT ID NCT02080767

What the study statuses mean

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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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 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.

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.

Lead sponsor

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

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

Sex

Anyone

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: * 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

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  1. The official record

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  2. A doctor treating you

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