Cohort study of human mpox virus disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 72
- 主要终点
- Time to lesion(s) resolution, defined a.From a start point of date that positive test is collected (or that treatment started if any delayed treatment) b. Until an endpoint of up to 14 days since inclusion (or since commencement of treatment if any delayed treatment). c.Where lesion resolution is the first day on which all lesions are resorbed, scabbed or desquamated and mucosal ulcers healed. d.And the absence of any serious complications
研究概览
简要总结
To describe clinical outcomes in patients with mpox virus disease treated and not treated with tecovirimat (or other antiviral drugs)
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •All patients, with either laboratory confirmed monkeypox virus disease OR Laboratory confirmation pending, but who are being managed as a presumptive case
- •Informed consent provided for participation in the study
排除标准
- •Presumptive cases with subsequent negative test for MPXV
- •Adults lacking capacity due to a previously present impairing condition
结局指标
主要结局
Time to lesion(s) resolution, defined a.From a start point of date that positive test is collected (or that treatment started if any delayed treatment) b. Until an endpoint of up to 14 days since inclusion (or since commencement of treatment if any delayed treatment). c.Where lesion resolution is the first day on which all lesions are resorbed, scabbed or desquamated and mucosal ulcers healed. d.And the absence of any serious complications
Time to lesion(s) resolution, defined a.From a start point of date that positive test is collected (or that treatment started if any delayed treatment) b. Until an endpoint of up to 14 days since inclusion (or since commencement of treatment if any delayed treatment). c.Where lesion resolution is the first day on which all lesions are resorbed, scabbed or desquamated and mucosal ulcers healed. d.And the absence of any serious complications
次要结局
- Clinical status defined by a) Clinical status on day 14 and day 28 according to an ordinal scale assessed by a physician or a study nurse. The ordinal scale is a) all lesions resolved and no serious complications, b) one or more lesions are active and no serious complications, c) serious complication and/or hospitalization due to mpox, or d) death. b) Evidence of recrudescence or relapse at day 60 and day 180.
- Virological status defined by: A) Change from baseline in mpox virus DNA levels in throat swabs on days 4, 8, 14 and 28; B)Change from baseline in Monkeypox virus DNA levels in blood on days 4, 8, 14 and 28, C) Presence of Monkeypox virus DNA in lesion swabs on days 4, 8, 14 and 28.
- In cohort receiving tecovirimat (or other antivirals): Number and type of Serious Adverse Events (SAEs), Suspected Adverse Reactions (SARS) and Suspected Unexpected Serious Adverse Reactions, (SUSARs) within 28 days of enrolment
- Outcome of pregnancy in women who are pregnant
研究者
ISARIC general enquiries
Scientific
University Of Oxford