719
Participants
Start Date
September 12, 2022
Primary Completion Date
October 23, 2024
Study Completion Date
September 30, 2025
Tecovirimat Oral Capsule
"Drug: Tecovirimat Oral capsules~* Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days~* Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days~* Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days"
Placebo
"Drug: Placebo Oral capsules~* Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days~* Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days~* Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days"
Tecovirimat Oral Capsule (Open Label)
"* Participants weighing \<3kg - Tecovirimat 533.3mg every 12 hours for 14 days~* Participants weighing 3 kg to less than 6kg- Tecovirimat 50 mg every 12 hours for 14 days~* Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days~* Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days~* Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg (2 capsules) every 12 hours for 14 days~* Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days~* Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days"
Weill Cornell Chelsea CRS, New York
Mount Sinai West Samuels CRS, New York
Harlem Prevention Center, New York
Columbia Physicians & Surgeons (P&S) CRS, New York
Weill Cornell Uptown CRS, New York
Bronx-Lebanon Hospital Center NICHD CRS, New York
Infectious Disease Clinical and Translational Research, New York
SUNY Stony Brook NICHD CRS, Stony Brook
University of Rochester Adult HIV Therapeutic, Rochester
University of Pittsburgh CRS, Pittsburgh
Penn Therapeutics CRS, Philadelphia
Johns Hopkins University CRS, Baltimore
Wake Forest Baptist Medical Center CRS, Winston-Salem
Duke University Medical Center CRS, Durham
The Ponce de Leon Center CRS, Atlanta
University of Florida Jacksonville NICHD CRS, Jacksonville
University of Florida, Gainesville
University of Miami / Jackson Memorial Hospital, Miami
Univ. of South Florida (USF) College of Medicine A, Tampa
Alabama CRS, Birmingham
St. Jude Children's Research Hospital ATN CRS, Memphis
Ohio State University CRS, Columbus
Case Western Reserve University CTU, Cleveland
Cincinnati CRS, Cincinnati
Henry Ford Hospital CRS, Detroit
Rush University Cook County Hospital Chicago NICHD CRS, Chicago
Washington University Therapeutics (WT) CRS, St Louis
North Texas Infectious Disease Consultants, Dallas
UT Southwestern Infectious Disease Research Unit, Dallas
Houston AIDS Research Team (HART) CRS, Houston
University of Colorado Denver NICHD CRS, Aurora
University of Colorado Hospital CRS, Aurora
Denver Public Health CRS, Denver
Kaiser Permanente Los Angeles Medical Center, Los Angeles
Los Angeles LGBT Center CRS, Los Angeles
UCLA CARE Center CRS, Los Angeles
Harbor University of California Los Angeles Center, Torrance
UCSD Antiviral Research Center CRS, San Diego
University of California, San Francisco HIV/AIDS CRS, San Francisco
University of California, Davis CRS, Sacramento
University of Washington Positive Research, Seattle
Massachusetts General Hospital CRS (MGH CRS), Boston
Brigham and Women's Hospital Therapeutics, Boston
New Jersey Medical School Clinical Research Center, Newark
Fundacion Huesped CRS, Buenos Aires
Centro de Pesquisas Clínicas IC-HCFMUSP CRS, São Paulo
Nutricion Mexico CRS, Mexico City
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS, Callao
Barranco CRS, Lima
San Miguel CRS, Lima
Socios En Salud Sucursal Peru, Lima
Via Libre CRS, Lima
Thai Red Cross AIDS Research Centre, Bangkok
Vaccine Trial Centre, Mahidol University CRS, Bangkok
SIGA Technologies
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH