Study of Tecovirimat for Human Monkeypox Virus (STOMP)
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|ClinicalTrials.gov Identifier: NCT05534984|
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : August 31, 2023
|Condition or disease||Intervention/treatment||Phase|
|Monkeypox MPOX||Drug: Tecovirimat Oral Capsule Drug: Placebo Drug: Tecovirimat Oral Capsule (Open Label)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||530 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease|
|Actual Study Start Date :||September 12, 2022|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||September 30, 2025|
|Experimental: Arm A||
Drug: Tecovirimat Oral Capsule
Drug: Tecovirimat Oral capsules
|Placebo Comparator: Arm B||
Drug: Placebo Oral capsules
|Experimental: Arm C||
Drug: Tecovirimat Oral Capsule (Open Label)
- 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 [ Time Frame: Up to day 29 ]
- Pain assessed by 11-point numerical rating scale for pain [ Time Frame: Through day 29 ]
- Time to development of severe HMPXV in those without severe HMPXV at baseline [ Time Frame: Through day 57 ]
- Level of HMPXV in blood [ Time Frame: Through day 57 ]
- Level of HMPXV in skin lesions [ Time Frame: Through day 57 ]
- Level of HMPXV in oropharynx [ Time Frame: Through day 57 ]
- Level of HMPXV in rectum [ Time Frame: Through day 57 ]
- Level of HMPXV in genital secretions [ Time Frame: Through day 57 ]
- Time to complete lesion healing defined as all lesions being re-epithelialized [ Time Frame: Up to day 29 ]
- Participant-reported adherence [ Time Frame: Through day 15 ]
- Participant-reported quality-of-life as measured by EQ-5D-5L [ Time Frame: Through day 29 ]
- Occurrence of Grade 3 or greater adverse event [ Time Frame: Through day 57 ]
- All-cause mortality [ Time Frame: Through day 57 ]
- Tecovirimat concentrations in blood in children less than 18 years of age [ Time Frame: Through day 15 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534984
|Contact: ACTG Clinicaltrials.gov Coordinator||Please email at:||ACTGCT.firstname.lastname@example.org|
|Study Chair:||Timothy Wilkin, MD, MPH||Cornell|