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Study of Tecovirimat for Human Mpox Virus

NCT05534984 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 719

Last updated 2026-02-10

Study results available
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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).

Conditions

Interventions

DRUG

Tecovirimat Oral Capsule

* Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days

DRUG

Placebo for Tecovirimat

* Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days

DRUG

Tecovirimat Oral Capsule (Open Label)

* Participants weighing \<3 kg - Tecovirimat 33.3 mg every 12 hours for 14 days * Participants weighing 3 kg to less than 6 kg- Tecovirimat 50 mg every 12 hours for 14 days * Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days * Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days * Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days

Sponsors & Collaborators

  • SIGA Technologies

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Timothy Wilkin, MD, MPH · Cornell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2024-10-23
Completion
2025-02-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Mexico
  • Peru
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534984 on ClinicalTrials.gov