A multicenter, single-arm trial to evaluate the efficacy and safety of vaccinia immune globulin therapy for patients with mpox or smallpox.

Morioka Shinichiro0 个研究点目标入组 20 人开始时间: 2023年3月30日最近更新: 2023年10月17日

试验速览

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•All 1)-3) must be satisfied. However, in the case of mpox, 4) and 5)must be also be satisfied.
•1) Persons who have given written consent to participate in the research.
•2) Persons who are at least 18 years old and less than 65 years old at the time of obtaining consent.
•3) Persons diagnosed with Mpox or smallpox. However, smallpox shall be diagnosed when the pathogen is detected from a specimen such as a blister, pustule, crust, pharyngeal swab, or blood, and Mpox from a skin or mucosal lesion, blister content fluid, nasopharyngeal swab, pharyngeal swab, anorectal swab, other mucosal swab, blood, urine, or other materials appropriate for the test method, by the following methods, respectively The diagnosis is made when pathogens are detected in the following ways :
•Direct observation of virus particles by electron microscopy
•Detection of pathogens by separation and identification
•Detection of pathogen antigens by fluorescentantibody method
•Detection of pathogen genes by PCR
•4) Those who will be treated with Tecovirimat in A multicenter, open-label, double-arm trial to evaluate the efficacy and safety of oral tecovirimat therapy for patients with mpox or smallpox . (hereafter referred to as the Tecopox study:jRCTs031220169).
•5) Patients with severe mpox or severe high-risk mpox

•1 Patients with a history of anaphylaxis or severe systemic reactions to human immunoglobulin products in the past
•2 Persons with a history of selective IgA deficiency and the presence of anti-IgA antibodies
•3 Persons with localized vaccinia keratitis
•4 Persons who are deemed inappropriate for inclusion in the study by the principal investigator

发起方

Morioka Shinichiro