A5418 STUDY OF TECOVIRIMAT FOR HUMAN MONKEYPOX VIRUS (STOMP)

A5418 TECOVIRIMAT 针对人猴痘病毒 (STOMP) 的研究

• 批准号: 10710436
• 负责人: BARBARA DRIVER
• 金额: $ 60.52万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-26 至 2024-03-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710436
• 关键词: AIDS clinical trial group; Adult; Affect; Appointment; Blood; Breast Feeding; Child; Clinic; Clinical Trials Data Monitoring Committees; Data; Disease; Double-Blind Method; Double-blind trial; Enrollment; Evaluation; Funding; Home; Human; Immunologic Deficiency Syndromes; Individual; Infection; Inflammatory; Investigation; Lesion; Liquid substance; Monitor; Monkeypox; Monkeypox virus; National Institute of Allergy and Infectious Disease; Pain; Participant; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Placebo Control; Placebos; Poxviridae; Protocols documentation; Randomized; Research Personnel; Safety; Sampling; Site; Skin; Smallpox; Swab; Symptoms; United States; United States Food and Drug Administration; United States National Institutes of Health; Virus Diseases; arm; clinical research site; cohort; diaries; healing; open label; participant safety; pill; pregnant; virtual

ACTG A5418: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease, Study of Tecovirimat for Human Monkeypox Virus (STOMP) CLINICAL COORDINATION, MONITORING AND EVALUATION OF THE AIDS CLINICAL TRIALS GROUP PROTOCOL A5418 STUDY OF TECOVIRIMAT FOR HUMAN MONKEYPOX VIRUS (STOMP). A5418 (STOMP) is a study of tecovirimat (also known as TPOCC) for the treatment of human monkeypox virus (HMPXV) disease. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring a Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, for the treatment of human monkeypox infection. The NIAID-funded AIDS Clinical Trials Group (ACTG) is leading the study, which is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from up to 80 clinical research sites nationwide. Adults with severe monkeypox, severe immunodeficiency, or severe inflammatory skin conditions; individuals taking certain medications that could affect tecovirimat levels; and pregnant people, people who are breastfeeding and children all will be enrolled in an open-label arm in which all participants receive tecovirimat. Other adult participants—530 total—will be randomly assigned in a 2:1 ratio to receive tecovirimat or placebo pills, which participants will take for 14 days. This part of the trial is double-blind, meaning neither participants nor investigators will know who is receiving placebo or tecovirimat. Investigators will gather data to determine if participants receiving tecovirimat heal more quickly and have less pain compared with those taking placebo. Participants will be followed for at least 57 days and will be asked to fill out a symptom diary, do daily skin checks at home and attend virtual and in-person clinic appointments. They also will undergo physical exams and will be asked to provide blood and other bodily fluid samples, including swabbing fluid from their lesions. Data on the safety and efficacy of tecovirimat will be submitted to the FDA. An independent Data and Safety Monitoring Board (DSMB) will monitor participant safety throughout the duration of the study. In addition, any participant in the randomized cohort who progresses to severe disease will be unblinded and given tecovirimat if they were randomized to placebo.

ACTG A5418：一项随机、安慰剂对照、双盲、特考韦瑞治疗人猴痘病毒病的安全性和有效性试验，特考韦瑞治疗人猴痘病毒的研究（STOMP） 艾滋病临床试验组方案A5418 Tecovirimat治疗人猴痘病毒（STOMP）研究的临床协调、监测和评价。 A5418（STOMP）是一项tecovirimat（也称为TPOCC）治疗人猴痘病毒（HMPXV）疾病的研究。 国家过敏和传染病研究所（NIAID），美国国立卫生研究院的一部分，正在赞助一项3期临床试验，评估抗病毒tecovirimat，也称为TPOXX，用于治疗人类猴痘感染。NIAID资助的艾滋病临床试验组（ACTG）正在领导这项研究，该研究目前正在美国招募患有猴痘感染的成人和儿童。研究人员的目标是从全国80个临床研究中心招募500多人。 患有严重猴痘、严重免疫缺陷或严重炎症性皮肤病的成年人;服用某些可能影响tecovirimat水平的药物的个人;孕妇、母乳喂养者和儿童都将参加开放标签组，所有参与者都将接受tecovirimat。其他成年参与者-总共530人-将以2：1的比例随机分配接受tecovirimat或安慰剂药丸，参与者将服用14天。试验的这一部分是双盲的，这意味着参与者和研究人员都不知道谁正在接受安慰剂或tecovirimat。 研究人员将收集数据，以确定与服用安慰剂的参与者相比，接受tecovirimat的参与者是否愈合更快，疼痛更少。参与者将被随访至少57天，并被要求填写症状日记，每天在家进行皮肤检查，并参加虚拟和面对面的诊所预约。他们还将接受体检，并被要求提供血液和其他体液样本，包括病变处的拭子液。 有关tecovirimat的安全性和有效性的数据将提交给FDA。独立的数据和安全性监查委员会（DSMB）将在整个研究期间监测受试者的安全性。此外，如果随机化队列中任何进展为重度疾病的受试者被随机分配至安慰剂组，则将揭盲并给予tecovirimat。