SmallpoxNCT02080767
Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
A study testing Tecovirimat in people with Smallpox and Monkeypox, run by U.S. Army Medical Research and Development Command.
Trial summary
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Tecovirimat
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
Read the detailed description
Rationale: Tecovirimat (TPOXX) is approved by FDA for treatment of smallpox. However, the therapeutic human dose for treatment of orthopox virus infections or a significant adverse reaction to vaccinia resulting from vaccination, secondary transmission, or other exposure, has not yet been fully established.
Treatment: Based on the interpretation of currently available animal efficacy and human safety and PK data, the proposed human adult or pediatric patient (≥ 40 kg) therapeutic regimen is 600 mg (3 capsules of 200 mg) orally twice daily (BID) for at least 14 days, taken 30 minutes after a meal consisting of about 600 calories and 30% (25 grams) fat, which is the same as treatment for smallpox. If a dose is missed it should be taken as soon as possible unless it is near the next dose time. Doses should not be doubled in the event of a missed dose. Treatment may be extended beyond 14 days, with sponsor approval, if the investigator deems necessary. Nonclinical safety data support use for up to 90 days.
The pediatric dosing recommendation is derived from the TPOXX package insert based on the body weight: 200 mg twice daily for patients of 13-25kg (29-45pounds); 400 mg twice daily for patients 25-40kg (55-87pounds) and 600 mg twice daily for pediatric patients over 40kg (88pounds)
Clinical Evaluation: Medical history and concomitant medications will be recorded, and a physical examination with vital signs [eg, body weight, blood pressure, heart rate, respiratory rate, temperature, and height (only once)] will be completed. Photographs of affected areas, should lesions develop, may be taken. Patients will be followed for at least 30 days after receiving the last tecovirimat dose or until their infection improves.
- Being tested
- Tecovirimat
- Medical subject headings
- Smallpox, Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TecovirimatDrug
Also called ST 246
Oral tablet 600mg daily dose(three capsules, 200 mg/capsule)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080767
- Sponsor's protocol ID
- M-10331
- Other IDs
- S-11-10
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2014
- Last updated
- 6 Jul 2026
- Results posted
- No
Publications
Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.
PubMed 36263798
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses
- ClinicalTrials.gov ID
- NCT02080767
- Acronym / sponsor ID
- M-10331
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
Detailed description
Rationale: Tecovirimat (TPOXX) is approved by FDA for treatment of smallpox. However, the therapeutic human dose for treatment of orthopox virus infections or a significant adverse reaction to vaccinia resulting from vaccination, secondary transmission, or other exposure, has not yet been fully established.
Treatment: Based on the interpretation of currently available animal efficacy and human safety and PK data, the proposed human adult or pediatric patient (≥ 40 kg) therapeutic regimen is 600 mg (3 capsules of 200 mg) orally twice daily (BID) for at least 14 days, taken 30 minutes after a meal consisting of about 600 calories and 30% (25 grams) fat, which is the same as treatment for smallpox. If a dose is missed it should be taken as soon as possible unless it is near the next dose time. Doses should not be doubled in the event of a missed dose. Treatment may be extended beyond 14 days, with sponsor approval, if the investigator deems necessary. Nonclinical safety data support use for up to 90 days.
The pediatric dosing recommendation is derived from the TPOXX package insert based on the body weight: 200 mg twice daily for patients of 13-25kg (29-45pounds); 400 mg twice daily for patients 25-40kg (55-87pounds) and 600 mg twice daily for pediatric patients over 40kg (88pounds)
Clinical Evaluation: Medical history and concomitant medications will be recorded, and a physical examination with vital signs [eg, body weight, blood pressure, heart rate, respiratory rate, temperature, and height (only once)] will be completed. Photographs of affected areas, should lesions develop, may be taken. Patients will be followed for at least 30 days after receiving the last tecovirimat dose or until their infection improves.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TecovirimatAlso: ST 246Oral tablet 600mg daily dose(three capsules, 200 mg/capsule) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 36263798Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tecovirimat in people with Smallpox and Monkeypox, run by U.S. Army Medical Research and Development Command.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances K Devlin (301-619-9904, frances.k.devlin.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.