TPOXX for Smallpox

Phase-Based Progress Estimates
Midwest Clinical Research Center, Dayton, OHSmallpoxTPOXX - Drug
18 - 80
All Sexes
What conditions do you have?

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

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

13 Primary · 16 Secondary · Reporting Duration: 60 days

60 days
Heart Rate
PR interval
Physical Exam findings; abnormalities reported
QRS interval
QT interval
QTc interval
QTcF interval
RR Duration
blood pressure
body temperature
clinical laboratory tests
heart rate
respiratory rate
Day 1
AUC tau
Day 28

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

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

ActiveComparator Group · 1 Intervention: TPOXX · Intervention Types: Drug
TPOXX Placebo
PlaceboComparator Group · 1 Intervention: TPOXX Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days

Who is running the clinical trial?

SIGA TechnologiesLead Sponsor
10 Previous Clinical Trials
1,306 Total Patients Enrolled
6 Trials studying Smallpox
639 Patients Enrolled for Smallpox
United States Department of DefenseFED
792 Previous Clinical Trials
212,848 Total Patients Enrolled
1 Trials studying Smallpox
100 Patients Enrolled for Smallpox
Ingrid MearaStudy DirectorSIGA Technologies
Dennis HrubyStudy DirectorSIGA Technologies

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 Jersey50.0%
North Carolina50.0%
How old are they?
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
High Point Clinical Trials Center100.0%
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?

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

Are participants still being sought for this research project?

"That is true. The website 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.