NCT06721585

Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only

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 - Extension Amendment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 328 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.

Detailed description

This open-label extension to the PALM007 protocol began in July 2024 after enrollment into the main study ended. It will further clinically characterize the natural history of mpox, and continue to identify recrudescent cases. Participants were initially provided SOC as well as open-access tecovirimat. The results of PALM007 were unblinded in August 2024, and although no safety concerns were observed with tecovirimat use, efficacy, defined by improvement in days to complete mpox skin lesion resolution, was not observed for tecovirimat compared to placebo. Therefore, the administration of tecovirimat in the extension amendment was discontinued in early August 2024, once these results were known, and only SOC continues to be provided. Participants are admitted to the hospital and receive SOC for mpox until they have recovered. Recovery is defined as resolution of all lesions and a negative blood test for MPXV. Participants will remain on study through day 59 but will not have a scheduled study visit unless they present with new mpox symptoms. Sick visits will be available for participants who reach full body lesion resolution but subsequently develop at least 1 new lesion consistent with mpox after discharge and on or before day 59, at which time viral PCR and clinical laboratory testing will be performed and participants will be offered standard of care. Initially, all participants presenting with mpox were eligible to enroll in this extension, regardless of disease severity. As of 05May2025, only patients with severe disease, defined as the presence of any of the following: flat lesions, pregnancy (due to risk for serious complications), suspected sickle cell disease, or severe clinical disease will be enrolled.

Conditions

• Mpox (Monkeypox)

Interventions

Type	Name	Description
DRUG	Tecovirimat Oral Capsule [Tpoxx]	Tecovirimat Oral Capsule 200 mg capsules Number of capsules and frequency of dosage will be based on participant weight: * ≥120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg) * 40 to \<120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg) * 25 to \<40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg) * 13 to \<25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg) * 6 to \<13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg) * 3 to \<6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg)
OTHER	Standard of Care (SOC)	Participants are provided SOC for mpox

Timeline

• Start date: 2024-07-10
• Primary completion: 2025-07-30
• Completion: 2025-08-30
• First posted: 2024-12-06
• Last updated: 2025-09-04

Locations

2 sites across 1 country: Democratic Republic of the Congo