Tecovirimat for Treatment of Monkeypox Virus

PHASE2CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

October 10, 2022

Primary Completion Date

September 3, 2024

Study Completion Date

September 3, 2024

Conditions
Monkeypox
Interventions
DRUG

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)"

DRUG

Placebo

Capsules to match tecovirimat

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