Study of Tecovirimat for Human Monkeypox Virus (STOMP)
For all people recently diagnosed and symptomatic for HMPXV
(Within two weeks of symptom onset)
UW Positive Research is looking for people of all ages, including children and pregnant/lactating adults, who have been recently diagnosed with Human Monkeypox Virus (HMPXV) and are symptomatic with at least one active skin lesion, mouth lesion, and/or rectal inflammation with or without visible ulcers to evaluate how effective and safe tecovirimat (TPOXX) is on pain improvement and the time of lesion healing.
The STOMP trial is sponsored by NIAID (National Institute of Allergy and Infectious Diseases) and led by the NIAID-funded ACTG
Background:
Monkeypox is caused by a virus. This virus is most often spread by close contact with someone who has monkeypox. Illness caused by monkeypox virus infection usually starts with a fever and feeling poorly before a rash begins. However, the rash may begin without other symptoms. The rash looks like raised bumps and pus-filled blisters (called lesions). They usually crust, scab, and fall off after about 2-4 weeks, sometimes leaving a scar.
About the study:
Tecovirimat is a drug that may help to treat infections caused by pox viruses. Tecovirimat is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children. However, we only know that it works in animals. We don’t know for sure if it works to treat any infections in people. The FDA has reviewed information on tecovirimat and determined that tecovirimat may help treat infection, including serious or potentially life-threatening disease, from poxviruses.
We are doing this study to see if tecovirimat is safe and whether it helps treatment monkeypox in people. The study will also help us understand more about how human monkeypox causes disease and how the body fights off infection.
Study drug will be either tecovirimat or placebo for tecovirimat.
Most people will be randomly assigned (like flipping a coin or rolling dice) to a study group. You and the study staff will not be able to choose which treatment group you are in. You will not know whether you are receiving active drug or placebo. Twice as many people will receive active drug as receive placebo in this study, so you are twice as likely to receive “real” drug.
Some people will be assigned to receive tecovirimat instead of being randomly assigned to a study group. If you belong to one of the groups below, you will receive tecovirimat – there is no chance you will receive placebo.
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Children under 18
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People who are pregnant or breastfeeding
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People with severe skin disease
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People with a severely suppressed immune system
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People with monkeypox disease in their eye or on their face (cheeks, nose, eyelid)
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People with severe monkeypox lesions that have to be treated surgically
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People who have to be hospitalized due to their monkeypox infection
Study Procedures:
If you are in this study, the following study procedures are required
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You will have physical exams
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You will record your symptoms daily
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You will provide blood and urine samples
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You will provide (or a study team member will obtain) swabs of the sores on your skin, mouth, vagina, rectum
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You will complete questionnaires about your symptoms
There is an optional intensive sampling cohort that we can tell you more about if you are interested.
Participants will be compensated up to $925
Physical exams, blood tests, swabs, and study medication will be provided at no cost to all participants.
Safe transportation and nutrition support will be provided to those in need during isolation at no cost.
Requirements:
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Laboratory-confirmed or presumptive HMPXV infection
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Laboratory-confirmed diagnosis includes PCR, culture, or antigen test obtained from a skin lesion, throat swab, or rectal swab obtained within 7 days (one week) prior to study entry
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Presumptive diagnosis includes sexual contact with one or more (1+) persons within 21 days (3 weeks) of symptom onset OR close contact to another person known to be infected with HMPX
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AND
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Skin lesions, mouth lesions, and/or rectal inflammation consistent with HMPXV
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HMPXV illness of less than 14 days prior to study entry
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People who engage in sex that could lead to pregnancy must agree to use contraception throughout the study
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At least one active (not yet scabbed) skin lesion, mouth lesion, or rectal inflammation with or without visible ulcers
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No prior use of tecovirimat
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Does not need intravenous dosing of tecovirimat
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open to ALL ages
Length of Study:
Approximately 2 months
If you are pregnant, we will contact periodically to see how your pregnancy goes and to know the health of your child.
Study Medications:
Study medication (tecovirimat or placebo) will be taken by mouth within 30 minutes after food every 12 hours* for 14 days.
*Dosing is adjusted on age and weight
Study Procedures:
Medical histories, blood draws, questionnaires, swab collections, physical exams, and study medication at remote and in-person visits.
Reimbursement:
Up to $925 for the duration of the study. Safe transportation and nutrition support provided to those in need during isolation at no cost.
Interested?
Please contact us at 206-773-7129 (call or text) or through the 'Contact Us' button at the bottom of this page.
