Tecovirimat for Treatment of Monkeypox Virus

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Description

The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.

Targeted Conditions

Study Overview

Start Date
October 10, 2022
Completion Date
September 1, 2024
Enrollment
600
Date Posted
September 29, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
L'Hôpital Général de Référence de Kole
Kole, Congo, The Democratic Republic of the

L'Hôpital Général de Référence de Tunda
Tunda, Congo, The Democratic Republic of the

Eligibility

Eligibility Criteria
This study has no age restriction.

Inclusion Criteria:

Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
Weight ≥3 kg

Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:

Hormonal contraception
Male or female condom
Diaphragm or cervical cap with a spermicide
Intrauterine device
Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so

Exclusion Criteria:

Current or planned use of a meglitinide (repaglinide, nateglinide)
Planned use of midazolam while on study drug
Severe anemia, defined as hemoglobin <7 g/dL
Current or planned use of another investigational drug at any point during study participation
Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration

Study Contact Info

Study Contact Name
Veronique Nussenblatt, MD ScM MHS; Olivier Tshiani Mbaya, MD MTM&GH
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.

If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox.
NCTid (if applicable)
NCT05559099