Mpox, Smallpox Mpox, Smallpox
Conditions
Interventions
Body weight 13 kg or more but less than 25 kg: 200 mg every 12 hours (as a rule, after breakfast and dinner) for 14 days
Body weight 25 kg or more but less than 40 kg: 400 mg every 12 hours (as a rule
Sponsors
Morioka Shinichiro
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. those who have been diagnosed with Mpox or smallpox 2. who have given written consent to participate in the study 3. who weigh 13 kg or more at the time of consent 4. who agree to be hospitalized until the first course of Tecovirimat treatment is completed 5. who agrees to remain hospitalized until completion of two or more consecutive courses of Tecovirimat treatment during the same period of hospitalization 6. a patient with severe Mpox or severe high-risk Mpox (however, this need not apply to smallpox patients)
Exclusion criteria
Exclusion criteria: 1. Persons who have had anaphylactic reactions to Tecovirimat or any of its components. 2. Persons who are judged 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 |
|---|---|
| Mortality 14 to 30 days after study inclusion Viral load in blood, throat swabs, skin, and urine 14, 21, 30, 60, and 120 days after study inclusion Sperm viral load 60 and 120 days after study entry Duration of fever of at least 37.5 degrees since study entry Occurrence of adverse events from study inclusion Performance status at study entry, 14 days, and 30 days (Lying in bed, able to leave bed for a short time, able to leave bed completely) | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security (JIHS)
Outcome results
None listed