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Tecovirimat for Treatment of Monkeypox Virus

NCT05559099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2025-10-09

Study results available
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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.

Conditions

  • Monkeypox

Interventions

DRUG

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)

DRUG

Placebo

Capsules to match tecovirimat

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2024-09-03
Completion
2024-09-03
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Drugs

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 NCT05559099 on ClinicalTrials.gov