Tecovirimat for Treatment of Monkeypox Virus
- Registration Number
- NCT05559099
- 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
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Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
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Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
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Weight ≥3 kg
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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
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Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
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Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
- 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 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 Frequency of solicited clinical symptoms up to day 59 Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhea, anorexia, cough, lymphadenopathy, dysphagia, sore throat, muscle aches, fatigue/lack of energy, fever, chills, night sweats, headache, ocular lesions, eye pain, change in vision, buccal ulcers, nasal congestion, cough, joint pain, pain with urination, painful skin lesions, pruritic skin lesions.
Number of participants with negative blood PCR results day 14 Proportion of participants with negative blood sample MPXV PCR results 14 days post-randomization
Number of participants with negative lesion swab PCR results day 14 Proportion of participants with negative lesion swab MPXV PCR results 14 days post-randomization
Mortality within the first 28 days post-randomization up to day 28 Number of deaths post-randomization
Number of days to participant death up to day 28 Number of days post-randomization
Incidence of adverse events requiring drug discontinuation up to day 14 Number of AEs
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 of participants with negative oropharyngeal swab PCR results day 14 Proportion of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization
Duration of solicited clinical symptoms up to day 59 Number of days
Incidence of other adverse events up to day 28 Number of AEs
Incidence of bacterial infections up to day 28 Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.
Incidence of serious adverse events requiring drug discontinuation up to day 14 Number of SAEs
Trial Locations
- Locations (2)
L'Hôpital Général de Référence de Kole
🇨🇩Kole, Congo, The Democratic Republic of the
L'Hôpital Général de Référence de Tunda
🇨🇩Tunda, Congo, The Democratic Republic of the