Tecovirimat for Treatment of Monkeypox Virus

Monkeypox Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease

Status Recruiting

Clinical Trial Summary

The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.

If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox. ;

Related Conditions & MeSH terms

• Monkeypox

• NCT number: NCT05559099
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: Veronique Nussenblatt, MD ScM MHS
• Phone: +1-240-812-2075
• Email: veronique.nussenblatt@nih.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2022
• Completion date: September 2024