Clinical trial NCT03972111: A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox
Official title: A Phase 4, Observational Field Study to Evaluate the Safety and Clinical Benefit of TPOXX (Tecovirimat)-Treated Patients Following Exposure to Variola Virus and Clinical Diagnosis of Smallpox Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Smallpox
Lead sponsor: SIGA Technologies
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2019-06-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess survival
timeFrame: 44 days post first dose of TPOXX
Secondary outcomes:
measure: Survival status
timeFrame: 14 days post first dose of TPOXX
measure: Time to death
timeFrame: 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
Other outcomes:
measure: Exploratory objective-TPOXX plasma concentration
timeFrame: 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.
Locations:
city: Corvallis
country: United States
facility: Investigator Site
state: Oregon
Study officials:
affiliation: SIGA Technologies
name: Dennis E. Hruby, PhD
role: STUDY_DIRECTOR
References: