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Can an antiviral drug stop smallpox? researchers track survival

NCT ID NCT03972111

Cure Sponsor: SIGA Technologies Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are observing patients diagnosed with smallpox who receive the antiviral drug tecovirimat (TPOXX). The study tracks how many patients survive at day 44 and monitors safety. Because smallpox is rare, the study relies on cases that occur naturally or in outbreaks, and it does not assign patients to different treatments. The goal is to learn whether tecovirimat helps people survive this severe disease.

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), an antiviral drug given as capsules
What this could lead to
If tecovirimat helps people survive smallpox, it could become a standard treatment for a disease with few options. The findings could also guide how antiviral drugs are used in future outbreaks.
What could go wrong
This is an observational study, so it cannot prove the drug works. Smallpox is rare, and the number of patients available to study may be very small, making it hard to draw firm conclusions. Tecovirimat can cause side effects, and its benefit against smallpox is not yet established.

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.

Started

Jan 2020

Expected to finish

Sep 2024

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Adult and pediatric patients who weigh ≥13 kg who receive FDA-approved TPOXX as part of their medical treatment for variola virus (VARV) infection in the United States (US). These patients will have suspected, probable, or confirmed smallpox. The purpose of this field study is to evaluate the safety, survival status, time to death, and smallpox rash progression in patients who are receiving TPOXX for the treatment of smallpox in the US

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.

Inclusion Criteria: * Able to provide informed consent or assent themselves or through a guardian or legally authorized representative, receiving or initiating treatment with TPOXX, and willing and able to adhere to the recommended procedures in the protocol. * Determined, per the clinical definition of smallpox, that the patient presenting with a case of acute, generalized vesicular/pustular rash meets Centers for Disease Control and Prevention (CDC) criteria of having confirmed, suspected, or probable smallpox and/or is at high or moderate risk for developing smallpox. * The CDC in coordination with the Department of Health and Human Services/Assistant Secretary for Preparedness and Response (ASPR) has released TPOXX to the physician or designated health authorities for patient treatment, and the CDC has provided physician contact information to PPD, the contract research organization. Exclusion Criteria: • Known allergy to tecovirimat and/or excipients of TPOXX.

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Conditions

The condition(s) this trial relates to.

smallpox

As listed by the trial registrant

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

Smallpox

Contacts and locations

Locations

  • Investigator Site

    Corvallis, Oregon, 97333, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.