An observational study in Smallpox, sponsored by SIGA Technologies. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by SIGA Technologies · Observational
Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease
Phase 4, Observational Field Study to evaluate safety and clinical benefit of TPOXX (tecovirimat) in patients treated with TPOXX following exposure to variola virus and a clinical diagnosis of smallpox disease.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
Browse Smallpox studies →SIGA Technologies is the lead sponsor of 9 studies on the registry; none are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days
Also known as: tecovirimat
Assess survival
To assess the overall survival at Day 44 following treatment with TPOXX
Time frame: 44 days post first dose of TPOXX
Survival status
Survival status after completion of 14 days of TPOXX treatment will be assessed by physician for inpatients and collected from patient via patient diary question or follow up telephone contact.
Time frame: 14 days post first dose of TPOXX
Time to death
Time to death after treatment with TPOXX
Time frame: From date of treatment with TPOXX until the date of death from any cause, whichever came first, assessed up to 44 days after TPOXX treatment
Exploratory objective-TPOXX plasma concentration
To evaluate the plasma concentration of TPOXX from any available samples
Time frame: Plasma samples will be collected to determine the plasma concentration of TPOXX from Days 1-14 of the TPOXX treatment period for inpatients. This data will be reported.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Sep 2024, 56 months after the start.
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This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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