Mpox, Smallpox Mpox, Smallpox
Conditions
Interventions
The drug is administered transvenously in 1-3 doses.
It should be administered directly from a dedicated intravenous line at a rate of no more than 2 mL/minute. For patients weighing less than 50 kg,
Sponsors
Morioka Shinichiro
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons diagnosed with Mpox or smallpox 2. Persons who have given written consent to participate in the study 3. who are at least 18 years old and less than or equal to 65 years old at the time of obtaining consent 4. Those who agree to be hospitalized until the first course of VIGIV treatment is completed 5. Persons who agree to remain hospitalized until completion of multiple courses of VIGIV treatment 6. patients with severe Mpox or severe high-risk Mpox (however, this need not apply to smallpox patients)
Exclusion criteria
Exclusion criteria: 1. a history of anaphylaxis or severe systemic reactions to human immunoglobulin products 2. a history of selective lgA deficiency and the presence of anti-lgA antibodies 3. has localized vaccinia keratitis 4. who are deemed by the investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Mortality 14 to 30 days after study inclusion 2. Viral load in blood, throat swabs, skin, and urine 14, 21, 30, 60, and 120 days after study inclusion 3. Sperm viral load 60 and 120 days after study entry 4. Duration of fever of at least 37.5 degrees since study entry 5. Occurrence of adverse events from study inclusion 6. Performance status at study entry, 14 days, and 30 days (Lying in bed, able to leave bed for a shorttime, able to leave bed completely) | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security (JIHS)
Outcome results
None listed