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

NCT06721585 | Completed

• 1 other identifier: PALM007-Ext
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Mpox; MPXV; Monkeypox

Outcome Measures

Primary Outcomes (1)

• Time to lesion resolution

  Number of days 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 (7)

• Time to lesion resolution for participants with symptom onset less than or equal to 7 days enrollment

  up to day 28

• Time to lesion resolution for participants with symptom onset greater than 7 days before enrollment

  up to day 28

• Number of participants that develop at least 1 new mpox lesion after discharge

  up to day 59

• Mortality within the first 28 days post-enrollment

  up to day 28

• Number of days to participant death

  up to day 59

Study Arms (2)

Open-access tecovirimat plus SOC for mpox

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.

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

Standard of care for mpox

Participants are provided SOC for mpox.

Other: Standard of Care (SOC)

Interventions

Tecovirimat Oral Capsule [Tpoxx] 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)

Also known as: TPOXX

Open-access tecovirimat plus SOC for mpox

Standard of Care (SOC) OTHER

Participants are provided SOC for mpox

Open-access tecovirimat plus SOC for mpox; Standard of care for mpox

Eligibility Criteria

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

Study Population

Adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo

You may qualify if:

• 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
• Severe disease, defined as the presence of at least one of the following:
• Flat lesions (flat and soft lesions; no pustules or vesicles visible to the eye)
• Pregnancy (due to risk of serious complication)
• Suspected sickle cell disease
• Severe clinical disease, defined as having at least 3 of the following:
• Lesion count greater than 250
• Fever for greater than 48 hours
• Hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg)
• Pallor
• Respiratory distress
• Altered mental status

You may not qualify if:

• Severe anemia, defined as hemoglobin less than 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

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 Links

• PALM 007 Record NCT05559099

Biospecimen

Retention: SAMPLES WITH DNA

Blood, mouth swabs, skin lesion swabs, , skin biopsies, conjunctival swabs

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

tecovirimat; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jean-Jacques Muyembe-Tamfum, MD PhD

  Kinshasa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: July 10, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)