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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Mpox (Monkeypox)

Treatments: Drug: Tecovirimat Oral Capsule [Tpoxx]; Other: Standard of Care (SOC)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06721585

PALM007-Ext

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

This study has no age restriction

Inclusion Criteria:

• Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
• Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
• Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
• Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
• Individuals previously enrolled in PALM007 will be included.

Exclusion Criteria:

• Severe anemia, defined as hemoglobin <7 g/dL
• Current or planned use of another investigational drug at any point during study participation
• Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study

Trial design

400 participants in 2 patient groups

Open-access tecovirimat plus SOC for mpox

Description:

Participants are provided SOC as well as open-access tecovirimat. Tecovirimat capsules are administered orally to participants for 14 days based on participant weight. Closed to new participants in August 2024.

Treatment:

Other: Standard of Care (SOC)

Drug: Tecovirimat Oral Capsule [Tpoxx]

Standard of care for mpox

Description:

Participants are provided SOC for mpox.

Treatment:

Other: Standard of Care (SOC)