A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease

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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.

Details
Age

Child to Adult

Eligibility

Laboratory-confirmed or presumptive HMPXV infection.

Type of Study

Treatment

Scope

National

Locations

Adult Infectious Disease Clinical Trials Center
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Thomas Campbell,  MD

Thomas Campbell, MD

Study ID

Protocol Number: 22-0797

More information available at ClinicalTrials.gov: NCT05534984

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