Orthopox Virus InfectionTPOXX IVNCT05380752
Tecovirimat Intravenous Treatment for Orthopox Virus Exposure
A study testing TPOXX IV (Tecovirimat Injection, 10 mg/mL) in people with Orthopox Virus Infection, run by U.S. Army Medical Research and Development Command.
Trial summary
To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopox Virus Infection
- What is being tested?
- TPOXX IV (Tecovirimat Injection, 10 mg/mL)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
- Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.
- Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., 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;
- Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
- Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
- Is available for clinical follow-up for duration of the treatment and follow-up period;
- Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.
Who cannot join
- Hypersensitivity to tecovirimat;
- Unable or unwilling to cooperate with the requirements of the protocol;
- Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.
About this study
Official title: EXPANDED ACCESS PROTOCOL FOR TREATMENT OF INDIVIDUALS FOLLOWING EXPOSURE TO ORTHOPOX VIRUSES WITH TPOXX IV (TECOVIRIMAT INJECTION, 10 mg/mL)
- To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure;
- To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).
- Conditions
- Orthopox Virus Infection
- Being tested
- TPOXX IV (Tecovirimat Injection, 10 mg/mL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPOXX IV (Tecovirimat Injection, 10 mg/mL)Drug
IV solution (10 mg/mL) must be diluted with 2 parts 0.9% normal saline or 5% dextrose solution prior to dosing. Once diluted, the drug product should be stored at 2-8°C (36-46°F) and used as soon as possible (i.e., not more than 24 hours after dilution). Given via an IV infusion pump over a 6 hour period, twice daily, and for up to 7 days, or until the physician determines oral TPOXX may be given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopox Virus InfectionStudies 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
- Collaborators
- SIGA Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380752
- Sponsor's protocol ID
- S-21-04
- Other IDs
- M-10922
- Acronym
- TPOXX IV
- Status last verified
- Mar 2025
- First submitted
- 27 Apr 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPANDED ACCESS PROTOCOL FOR TREATMENT OF INDIVIDUALS FOLLOWING EXPOSURE TO ORTHOPOX VIRUSES WITH TPOXX IV (TECOVIRIMAT INJECTION, 10 mg/mL)
- ClinicalTrials.gov ID
- NCT05380752
- Acronym / sponsor ID
- TPOXX IV / S-21-04
- Conditions
- Orthopox Virus Infection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- SIGA Technologies
- First posted
- 19 May 2022 (actual)
- 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.
- To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure;
- To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.
- Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., 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;
- Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
- Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
- Is available for clinical follow-up for duration of the treatment and follow-up period;
Key exclusion criteria (3 listed)
- Hypersensitivity to tecovirimat;
- Unable or unwilling to cooperate with the requirements of the protocol;
- Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.
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 |
|---|---|---|
| TPOXX IV (Tecovirimat Injection, 10 mg/mL)IV solution (10 mg/mL) must be diluted with 2 parts 0.9% normal saline or 5% dextrose solution prior to dosing. Once diluted, the drug product should be stored at 2-8°C (36-46°F) and used as soon as possible (i.e., not more than 24 hours after dilution). Given via an IV infusion pump over a 6 hour period, twice daily, and for up to 7 days, or until the physician determines oral TPOXX may be given | 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 10 Mar 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TPOXX IV (Tecovirimat Injection, 10 mg/mL) in people with Orthopox Virus Infection, 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 6 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 10 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 10 Mar 2025.