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

Clinical Trial Details

The purpose of this study is to see if the drug tecovirimat helps people with mpox (formally known as monkeypox) heal faster. The study will also help us understand more about how human mpox causes disease and how the body fights off infection. 
   
Tecovirimat is approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox and has been given safely to some people with mpox in the recent outbreak. It is considered investigational in this study as it has not yet been approved to treat mpox.
   
Participants in this study will be randomized to receive either tecovirimat or placebo. Participants will also have physical exams, record their symptoms daily and complete questionnaires, provide blood and urine samples, and provide (or a study team member will obtain) swabs of the sores on their body.
   
Participants have the option of remote participation that does not include specimen collection. The total length of study participation is about two months. 

Key Eligibility: 
  1. Laboratory-confirmed or presumptive mpox infection. 
  2. Mpox illness of less than 14 days duration. 
  3. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis (inflammation of the lining of the rectum) with or without visible ulcers. 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jonathan Berardi, NP
212-746-4177
mpox@med.cornell.edu

Chelsea - Manhattan

Chelsea Clinical Trial Location

Contact(s)

Jonathan Berardi, NP
212-746-4177
mpox@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2208025213

ClinicalTrials.gov:

NCT05534984

Sponsor:

A5418

Status

Open to Enrollment

Age Group

Adult

Sponsor