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Antiviral

TPOXX for Smallpox

Phase 3
Waitlist Available
Research Sponsored by SIGA Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart Rate
PR interval
Physical Exam findings; abnormalities reported
+10 more
Secondary outcome measures
%Fluctuation
AUC tau
AUC-∞
+13 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TPOXXActive Control1 Intervention
Treatment Group 1: An oral dose of 600 mg (3 × 200 mg capsules) TPOXX BID (every 12 hours [±30 minutes]) for 28 days (Day 1 to Day 28)
Group II: TPOXX PlaceboPlacebo Group1 Intervention
Treatment Group 2: An oral dose of placebo (3 capsules identical to TPOXX) BID (every 12 hours [±30 minutes]) for 28 days (Day 1 to Day 28)

Find a Location

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
861 Previous Clinical Trials
226,727 Total Patients Enrolled
1 Trials studying Smallpox
100 Patients Enrolled for Smallpox
Ingrid MearaStudy DirectorSIGA Technologies

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New Jersey
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
High Point Clinical Trials Center
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

How many weeks does this trial last?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Just want to help.
PatientReceived 1 prior treatment
~156 spots leftby Apr 2025