Tecovirimat for Treatment of Monkeypox Virus

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: Monkeypox

Treatments: Drug: Tecovirimat Oral Capsule; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05559099

PALM 007

Details and patient eligibility

About

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.

Full description

This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.

If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox.

Enrollment: 597 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

This study has no age restriction.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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597 participants in 2 patient groups, including a placebo group

Tecovirimat

Experimental group

Description:

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

Treatment:

Drug: Tecovirimat Oral Capsule

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo