Platform to Evaluate the Safety and Efficacy of Treatments for Mpox or Smallpox. sub-protocol01 Tecovirimat

JRCT ID: jRCTs031240110

Registered date:27/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Mpox, Smallpox
• Date of first enrollment: 01/11/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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, after breakfast and dinner) for 14 days
Body weight of 40 kg or more: 600 mg every 12 hours (in principle, after breakfast and dinner) for 14 days
A course of 14 days of administration is defined as one course.
If deemed necessary by the investigator, two or more courses may be administered.

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

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)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. who weighs 13kg or more at the time consent is obtained
2. who agree to be hospitalized until completion of one course of treatment when taking Tecobilimat internally
3. Patients with severe empox* or severe high-risk empox* (however, this need not apply to smallpox patients)

Exclude criteria

1. Persons who have had anaphylactic reactions to Tecobilimat or any of its components.
2. Persons who are judged by the investigator to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Morioka Shinichiro
• Secondary Sponsor: Ohmagari Norio,AMED