Tecovirimat for Treatment of Monkeypox Virus

NCT05559099 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PALM 007
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Monkeypox; MPXV

Outcome Measures

Primary Outcomes (1)

• Time to Lesion Resolution

  Number of days from randomization to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.

  Up to day 28

Secondary Outcomes (10)

• Time to Lesion Resolution for Participants With Symptom Onset Less Than or Equal to 7 Days Before Randomization

  up to day 28

• Time to Lesion Resolution for Participants With Symptom Onset Greater Than 7 Days Before Randomization

  up to day 28

• Number and Percentage of Participants With Negative Blood PCR Results

  day 14

• Number and Percentage of Participants With Negative Oropharyngeal Swab PCR Results

  day 14

• Number and Percentage of Participants With Negative Lesion Swab PCR Results

  day 14

Study Arms (2)

Tecovirimat

EXPERIMENTAL

Tecovirimat capsules administered orally to participants for 14 days plus SOC.

Drug: Tecovirimat Oral Capsule

Placebo

PLACEBO COMPARATOR

Matching placebo capsules administered orally to participants for 14 days plus SOC.

Drug: Placebo

Interventions

Tecovirimat Oral Capsule DRUG

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)

Also known as: TPOXX

Tecovirimat

Placebo DRUG

Capsules to match tecovirimat

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
• Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
• Weight ≥3 kg
• Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:
• Hormonal contraception
• Male or female condom
• Diaphragm or cervical cap with a spermicide
• Intrauterine device
• 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

You may not qualify if:

• Current or planned use of a meglitinide (repaglinide, nateglinide)
• Planned use of midazolam while on study drug
• 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
• Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (2)

L'Hôpital Général de Référence de Kole

Kole, Democratic Republic of the Congo

Location

L'Hôpital Général de Référence de Tunda

Tunda, Democratic Republic of the Congo

Location

Related Publications (1)

• PALM007 Writing Group; Ali R, Alonga J, Biampata JL, Kombozi Basika M, Maljkovic Berry I, Bisento N, Blum E, Bonnett T, Cone K, Crozier I, Davey R, Dilu A, Dodd LE, Gulati I, Hruby D, Ibanda A, Isse F, Kasareka SS, Kayembe G, Kojan R, Luzolo EK, Lane HC, Lawanga L, Liesenborghs L, Shosongo Lunghe C, Lula Y, Lusakibanza M, Lutete GT, Mbala-Kingebeni P, Miranda A, Mukadi-Bamuleka D, Mukendi G, Lupola PM, Muyembe-Tamfum JJ, Ndungunu R, Nganga B, Ntamabyaliro N, Nussenblatt V, Omulepu I, Omalokoho Onosomba J, Proschan M, Rubenstein K, Saknite I, Schechner A, Shaw-Saliba K, Sivahera B, Smolskis M, Tillman A, Tkaczyk E, Tshimanga C, Tshiani Mbaya O, Tshomba A, Yemba Unda Tshomba F, Vallee D, Vogel S, Weyers S. Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo. N Engl J Med. 2025 Apr 17;392(15):1484-1496. doi: 10.1056/NEJMoa2412439.

  PMID: 40239067 DERIVED

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Results Point of Contact

• Title: Lori Dodd
• Organization: National Institute of Allergy and Infectious Diseases

doddl@niaid.nih.gov

2406695247

Study Officials

• Jean-Jacques Muyembe-Tamfum, MD PhD

  Kinshasa University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 29, 2022
• Study Start: October 10, 2022
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)