Study Summary
This trial will test how safe and tolerable an experimental drug is when taken twice daily for 28 days, as well as how the drug is processed by the body.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
13 Primary · 16 Secondary · Reporting Duration: 60 days
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
TPOXX
1 of 2
TPOXX Placebo
1 of 2
Active Control
Non-Treatment Group
445 Total Participants · 2 Treatment Groups
Primary Treatment: TPOXX · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New Jersey | 50.0% |
| North Carolina | 50.0% |
How old are they?
| 65+ | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
What site did they apply to?
| High Point Clinical Trials Center | 100.0% |
Why did patients apply to this trial?
- "Just want to help"
What questions have other patients asked about this trial?
- "How many weeks does this trial last?"
How many prior treatments have patients received?
| 1 | 100.0% |
Frequently Asked Questions
Is TPOXX a common prescription medication?
"TPOXX was first trialled in 2022 at Meridian Clinical Research, with 5 completed trials as of now. 3 more trials are underway and recruiting patients from Miami, Florida and other locations." - Anonymous Online Contributor
How many patients are included in this clinical trial currently?
"This study requires 445 patients that meet the eligibility requirements. The sponsor, SIGA Technologies, will be conducting the trial at various sites; two examples are Clinical Pharmacology of Miami, LLC and Midwest Clinical Research Center." - Anonymous Online Contributor
What are the desired outcomes of this research project?
"The primary outcome SIGA Technologies plans to measure over the course of 60 days is clinical laboratory tests. Additionally, this trial will be measuring secondary outcomes including AUC tau, Cmin, and Cavg." - Anonymous Online Contributor
Is this research project something new?
"3 studies concerning TPOXX are currently underway, with locations in 9 cities and 1 nation. The initial study, which occurred in 2022 and was sponsored by SIGA Technologies, involved 100 patients. It completed Phase 2 drug approval and 5 more studies have been conducted since then." - Anonymous Online Contributor
How many research facilities are currently testing this hypothesis?
"To make participation more convenient for patients, this study is running at 8 locations. If you live near Miami, Dayton or North Charleston, there is likely a trial site close to you. Additionally, there are 8 other sites located across the United States of America." - Anonymous Online Contributor
Are participants still being sought for this research project?
"That is true. The website clinicaltrials.gov has the latest information on this trial, which began recruiting on 29 March 2022. As of 6 October 2020, the study needs 445 more participants from 8 different locations." - Anonymous Online Contributor
If I qualify, can I take part in this research project?
"To be eligible for this smallpox clinical trial, candidates must meet the age criteria of being between 18-80 years old. There are a total of 445 spots available." - Anonymous Online Contributor
For this particular test, are geriatric patients being accepted?
"As this clinical trial's inclusion criteria state, eligible participants must be between 18 to 80 years old." - Anonymous Online Contributor
Has TPOXX received the green light from the FDA?
"TPOXX is currently in Phase 3 trials, which implies that while there is data supporting its efficacy, multiple rounds of testing are required to confirm its safety. Our team gives it a score of 3." - Anonymous Online Contributor