Tecovirimat for Treatment of Monkeypox Virus

Phase 2

Completed

Conditions: Monkeypox

Interventions: Drug: Tecovirimat Oral Capsule
Drug: Placebo

Registration Number: NCT05559099

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 597

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tecovirimat	Tecovirimat Oral Capsule	Tecovirimat capsules administered orally to participants for 14 days plus SOC.
Placebo	Placebo	Matching placebo capsules administered orally to participants for 14 days plus SOC.

Primary Outcome Measures

Name	Time	Method
Time to Lesion Resolution	Up to day 28	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.

Secondary Outcome Measures

Name	Time	Method
Time to Lesion Resolution for Participants With Symptom Onset Less Than or Equal to 7 Days Before Randomization	up to day 28	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.
Time to Lesion Resolution for Participants With Symptom Onset Greater Than 7 Days Before Randomization	up to day 28	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.
Number and Percentage of Participants With Negative Blood PCR Results	day 14	Percentage of participants with negative blood sample MPXV PCR results 14 days post-randomization, out of those positive at baseline
Number and Percentage of Participants With Negative Oropharyngeal Swab PCR Results	day 14	Number and percentage of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization, out of those positive at baseline
Number and Percentage of Participants With Negative Lesion Swab PCR Results	day 14	Number and and percentage of participants with negative lesion swab MPXV PCR results 14 days post-randomization, of those positive at baseline
Mortality Within the First 28 Days Post-randomization	up to day 28	Number of deaths post-randomization
Incidence of Non-fatal Serious Adverse Events Requiring Permanent Drug Discontinuation	Up to day 14	Number of participants with a non-fatal serious adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days)
Incidence of Non-fatal Adverse Events Requiring Permanent Drug Discontinuation	Up to day 14	Number of participants with a non-fatal adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days)
Incidence of Adverse Events	up to day 28	Number of participants with an adverse event up to day 28
Incidence of Bacterial Infection Adverse Events	up to day 28	Number of participants with a bacterial infection adverse event up to day 28

Trial Locations

Locations (2): L'Hôpital Général de Référence de Kole
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Kole, Democratic Republic of the Congo
L'Hôpital Général de Référence de Tunda
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Tunda, Democratic Republic of the Congo
L'Hôpital Général de Référence de Kole
🇨🇩Kole, Democratic Republic of the Congo