European Randomised Clinical Trial on MPOX Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Time to complete mpox lesion resolution
研究概览
简要总结
The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.
The main questions it aims to answer are:
- Is tecovirimat effective in treating mpox infection.
- Is tecovirimat safe to treat patients with mpox infection.
Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.
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)
盲法说明
The trial is controlled with matching placebo. Unblinding after database lock.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
- •The presence of active skin or mucosal lesion(s)
- •Signed Informed Consent Form
排除标准
- •Age <18 years.
- •Body weight <40 kg
- •Pregnant and breastfeeding patients are not eligible for inclusion in this study.
- •Lack of mental capacity to provide informed consent
- •Trial participation is considered not in the best interest of patient
- •Known hypersensitivity to the active substance or to any of the excipients of the study drug.
- •Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
- •Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
- •The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
- •The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
- •The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
研究组 & 干预措施
Tecovirimat
Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
干预措施: Tecovirimat Oral Capsule (Drug)
Placebo
Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to complete mpox lesion resolution
时间窗: 28 days
Time in days until day 28 after randomization, until the first day on which all lesions are completely healed with a new fresh layer of skin.
次要结局
- Time to active lesion resolution(28 days)
- Status of the lesions on day 7, 14 and 28(Day 7, day 14 and day 28)
- All-cause mortality(Assessed on day 28 and on day 90)
- Time to resolution of symptoms(90 days)
- Frequency of AEs, SAEs and SUSARs(Assessed within 28 days and within 90 days.)
- Occurrence of a negative monkeypox PCR of skin or mucosal swab(Days 7, 14 and 28)
- Change from baseline in quality of life(Assessed on day 14 and day 90.)
- Time to complication or all-cause admission to hospital or all-cause death(Assessed within 28 days and within 90 days.)
- Persistence of scars and skin discoloration(Assessed on day 90)
- Resolution of pain(Assessed on days 7, 14 and 90.)
研究者
Miquel Ekkelenkamp
Clinical Microbiologist
UMC Utrecht