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

JRCT ID: jRCTs031220744

Registered date:30/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: mpox or smallpox
• Date of first enrollment: 06/09/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): VIG vaccinia immunoglobulin intravenous formulation is administered intravenously only once.

Outcome(s)

• Primary Outcome: Percentage of patients with a Ct value of 40 or higher on skin sample PCR testing at the site of the skin rash 14 days after study inclusion

Secondary Outcome

Virus mortality at 14 and 30 days after entry into the study
Virus levels in blood, throat wipes, skin, and urine at 14, 21, 30, 60, and 120 days after inclusion
Duration of fever of 37.5 or higher after entry into the study
Adverse events since study entry
General condition (bedridden, briefly bedridden, or completely bedridden) at study entry, 14 days, and 30 days after entry

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Morioka Shinichiro
• Secondary Sponsor: Ohmagari Norio,Japan Agency for Medical Research and Development,Ministry of Health, Labour, and Welfare