Tecovirimat Oral Capsule for Monkeypox

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pittsburgh CRS, Pittsburgh, PA
Monkeypox
Tecovirimat Oral Capsule - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Through day 57

Through day 15
Participant-reported adherence
Tecovirimat concentrations in blood in children less than 18 years of age
Through day 29
Pain assessed by 11-point numerical rating scale for pain
Participant-reported quality-of-life as measured by EQ-5D-5L
Through day 57
All-cause mortality
Level of HMPXV in blood
Level of HMPXV in genital secretions
Level of HMPXV in oropharynx
Level of HMPXV in rectum
Level of HMPXV in skin lesions
Occurrence of Grade 3 or greater adverse event
Time to development of severe HMPXV in those without severe HMPXV at baseline
Up to day 29
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 to complete lesion healing defined as all lesions being re-epithelialized

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Arm A
1 of 3
Arm C
1 of 3
Arm B
1 of 3
Experimental Treatment
Non-Treatment Group

530 Total Participants · 3 Treatment Groups

Primary Treatment: Tecovirimat Oral Capsule · Has Placebo Group · Phase 3

Arm A
Drug
Experimental Group · 1 Intervention: Tecovirimat Oral Capsule · Intervention Types: Drug
Arm C
Drug
Experimental Group · 1 Intervention: Tecovirimat Oral Capsule (Open Label) · Intervention Types: Drug
Arm B
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through day 57
Closest Location: University of Pittsburgh CRS · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
2011First Recorded Clinical Trial
1 TrialsResearching Monkeypox
25 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,108 Previous Clinical Trials
4,671,914 Total Patients Enrolled
1 Trials studying Monkeypox
210 Patients Enrolled for Monkeypox
SIGA TechnologistUNKNOWN
SIGA TechnologiesIndustry Sponsor
10 Previous Clinical Trials
1,321 Total Patients Enrolled
1 Trials studying Monkeypox
12 Patients Enrolled for Monkeypox
Timothy Wilkin, MD, MPHStudy ChairCornell
1 Previous Clinical Trials
46 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are <14 days from the date of the first symptoms of HMPXV illness.
You have at least one active skin lesion, mouth lesion, or proctitis with or without visible ulcers.
You must be of reproductive potential and agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy.
You are at least 18 years old.\n
You are under the age of 18 years.
You have severe HMPXV disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.