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NCT05534984 · ClinicalTrials.gov registry record · Phase 3
Study of Tecovirimat for Human Mpox Virus
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 3
- Development phase
- 719
- Enrollment target
NCT05534984: Clinical Trial Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05534984 is a Phase 3 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 719 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05534984, a Phase 3 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 719 participants
- Enrollment target
Study Summary
The purpose of this study was to see if tecovirimat is safe and successful at treating mpox. The main questions were whether tecovirimat reduced time to lesion resolution and pain compared to placebo (no treatment).
Primary Outcome
Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative proportion with clinical resolution was estimated using the Aalen-Johansen estimator. The treatment effect, i.e., the subdistribution hazard ratio of tecovirimat relative to placebo, was estimated using the Fine and Gray subdistribution proportional hazards model. All-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of
Interventions
- DRUG Tecovirimat Oral Capsule
- DRUG Placebo for Tecovirimat
- DRUG Tecovirimat Oral Capsule (Open Label)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2025-02-22 |
| Phase | Phase 3 |
Why NCT05534984 stopped before completion
NCT05534984 is an interventional study that assigns participants to a tested intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Tecovirimat Oral Capsule is the first listed.
NCT05534984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05534984 about?
NCT05534984 is a clinical study titled "Study of Tecovirimat for Human Mpox Virus". The purpose of this study was to see if tecovirimat is safe and successful at treating mpox. The main questions were whether tecovirimat reduced time to lesion resolution and pain compared to placebo (no treatment).
What is the current status of trial NCT05534984?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 719 participants. The study started on 2022-09-08. Estimated completion is 2025-02-22.
What interventions are being tested in trial NCT05534984?
The interventions under investigation include: Tecovirimat Oral Capsule (DRUG), Placebo for Tecovirimat (DRUG), Tecovirimat Oral Capsule (Open Label) (DRUG).
Who is sponsoring clinical trial NCT05534984?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05534984's enrollment target sits among peer trials
719 498th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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