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

NCT06721585 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 328

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

  • Mpox (Monkeypox)

Interventions

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

Sponsors & Collaborators

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jean-Jacques Muyembe-Tamfum, MD PhD · Kinshasa University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-30
Completion
2025-08-30

Countries

  • Democratic Republic of the Congo

Study Locations

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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 NCT06721585 on ClinicalTrials.gov