A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- Time to Lesion Resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tecovirimat
Tecovirimat capsules administered orally to participants for 14 days plus SOC.
干预措施: Tecovirimat Oral Capsule (Drug)
Placebo
Matching placebo capsules administered orally to participants for 14 days plus SOC.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Lesion Resolution
时间窗: 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.
次要结局
- 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)
- Mortality Within the First 28 Days Post-randomization(up to day 28)
- Incidence of Non-fatal Serious Adverse Events Requiring Permanent Drug Discontinuation(Up to day 14)
- Incidence of Non-fatal Adverse Events Requiring Permanent Drug Discontinuation(Up to day 14)
- Incidence of Adverse Events(up to day 28)
- Incidence of Bacterial Infection Adverse Events(up to day 28)