Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only

CompletedOBSERVATIONAL
Enrollment

328

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

August 30, 2025

Conditions
Mpox (Monkeypox)
Interventions
DRUG

Tecovirimat Oral Capsule [Tpoxx]

"Tecovirimat Oral Capsule 200 mg capsules~Number of capsules and frequency of dosage will be based on participant weight:~* ≥120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg)~* 40 to \<120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg)~* 25 to \<40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg)~* 13 to \<25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg)~* 6 to \<13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg)~* 3 to \<6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg)"

OTHER

Standard of Care (SOC)

Participants are provided SOC for mpox

Trial Locations (2)

Unknown

L'Hôpital Général de Référence de Kole, Kole

L'Hôpital Général de Référence de Tunda, Tunda

All Listed Sponsors
collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT06721585 - Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only | Biotech Hunter | Biotech Hunter