Study of Tecovirimat for Human Mpox Virus
- Conditions
- MPOX
- Interventions
- Registration Number
- NCT05534984
- Brief Summary
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.
- Detailed Description
Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants who are pregnant or breastfeeding will receive open-label tecovirimat after discussion of the potential risks and benefits. Participants less than 18 years of age will receive open-label tecovirimat. Participants receiving a potent inducing concomitant medication will receive open-label tecovirimat.
Once enrolled, study drug administration will be for 14 days. Participants who progress to severe HMPXV disease will be seen in person for a confirmation of progression. If severe disease is confirmed, participants will stop blinded study treatment and start a 14-day course of open-label tecovirimat. Participants reporting severe pain 5 days after randomization will stop blinded study treatment and start a 14-day course of open-label tecovirimat.
Participants will self-monitor skin and/or mucosal lesions daily through 29 days or resolution (whichever comes first), complete a daily diary of symptoms and complete a daily numerical rating scale for pain assessment.
Participants will be seen weekly through day 29 for assessment of HMPXV disease, safety assessments, HMPXV sampling similar to that described for entry, and swabbing of new HMPXV lesions.
Participants will be seen at day 57 to assess for possible recrudescence of infection (i.e., new lesions occurring after initial resolution of disease.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 719
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Tecovirimat Oral Capsule - Arm B Placebo - Arm C Tecovirimat Oral Capsule (Open Label) -
- Primary Outcome Measures
Name Time Method Time to clinical resolution, defined as the first day on which all skin lesions are scabbed, desquamated or healed, and visible mucosal lesions are healed Up to day 29
- Secondary Outcome Measures
Name Time Method Pain assessed by 11-point numerical rating scale for pain Through day 29 Time to development of severe HMPXV in those without severe HMPXV at baseline Through day 57 Level of HMPXV in blood Through day 57 Level of HMPXV in skin lesions Through day 57 Level of HMPXV in oropharynx Through day 57 Level of HMPXV in rectum Through day 57 Level of HMPXV in genital secretions Through day 57 Time to complete lesion healing defined as all lesions being re-epithelialized Up to day 29 Participant-reported adherence Through day 15 Participant-reported quality-of-life as measured by EQ-5D-5L Through day 29 Occurrence of Grade 3 or greater adverse event Through day 57 All-cause mortality Through day 57 Tecovirimat concentrations in blood in children less than 18 years of age Through day 15
Trial Locations
- Locations (60)
Alabama CRS
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Los Angeles LGBT Center CRS
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
University of California, Davis CRS
🇺🇸Sacramento, California, United States
UCSD Antiviral Research Center CRS
🇺🇸San Diego, California, United States
University of California, San Francisco HIV/AIDS CRS
🇺🇸San Francisco, California, United States
Harbor University of California Los Angeles Center
🇺🇸Torrance, California, United States
University of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Denver Public Health CRS
🇺🇸Denver, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
University of Miami / Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Univ. of South Florida (USF) College of Medicine A
🇺🇸Tampa, Florida, United States
The Ponce de Leon Center CRS
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Cook County Hospital Chicago NICHD CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins University CRS
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital CRS (MGH CRS)
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital Therapeutics
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital CRS
🇺🇸Detroit, Michigan, United States
Washington University Therapeutics (WT) CRS
🇺🇸Saint Louis, Missouri, United States
Columbia Physicians & Surgeons (P&S) CRS
🇺🇸New York, New York, United States
Weill Cornell Uptown CRS
🇺🇸New York, New York, United States
New Jersey Medical School Clinical Research Center
🇺🇸Newark, New Jersey, United States
Weill Cornell Chelsea CRS
🇺🇸New York, New York, United States
Mount Sinai West Samuels CRS
🇺🇸New York, New York, United States
Harlem Prevention Center
🇺🇸New York, New York, United States
Bronx-Lebanon Hospital Center NICHD CRS
🇺🇸New York, New York, United States
Infectious Disease Clinical and Translational Research
🇺🇸New York, New York, United States
Fundacion Huesped CRS
🇦🇷Buenos Aires, Argentina
Hospital Nossa Senhora da Conceicao CRS
🇧🇷Porto Alegre, Brazil
University of Rochester Adult HIV Therapeutic
🇺🇸Rochester, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
Duke University Medical Center CRS
🇺🇸Durham, North Carolina, United States
Wake Forest Baptist Medical Center CRS
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve University CTU
🇺🇸Cleveland, Ohio, United States
Ohio State University CRS
🇺🇸Columbus, Ohio, United States
Penn Therapeutics CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS
🇺🇸Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital ATN CRS
🇺🇸Memphis, Tennessee, United States
North Texas Infectious Disease Consultants
🇺🇸Dallas, Texas, United States
UT Southwestern Infectious Disease Research Unit
🇺🇸Dallas, Texas, United States
Houston AIDS Research Team (HART) CRS
🇺🇸Houston, Texas, United States
University of Texas, San Antonio
🇺🇸San Antonio, Texas, United States
University of Washington Positive Research
🇺🇸Seattle, Washington, United States
Centro de Pesquisas ClÃnicas IC-HCFMUSP CRS
🇧🇷São Paulo, Brazil
National Center for Global Health and Medicine
🇯🇵Tokyo, Japan
Nutricion Mexico CRS
🇲🇽Mexico City, Mexico
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos ClÃnicos (UNIDEC) CRS
🇵🇪Callao, Peru
Barranco CRS
🇵🇪Lima, Peru
San Miguel CRS
🇵🇪Lima, Peru
Socios En Salud Sucursal Peru
🇵🇪Lima, Peru
Via Libre CRS
🇵🇪Lima, Peru
Soweto CRS
🇿🇦Johannesburg, South Africa
University of the Witwatersrand Helen Joseph (WITS HJH)
🇿🇦Johannesburg, South Africa
Thai Red Cross AIDS Research Centre
🇹ðŸ‡Bangkok, Thailand
Vaccine Trial Centre, Mahidol University CRS
🇹ðŸ‡Bangkok, Thailand