Clinical trial NCT05559099: Tecovirimat for Treatment of Monkeypox Virus
Official title: A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Monkeypox
Keywords: Monkeypox
MPXV
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
First posted: 2022-09-29
Enrollment: 597
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

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

Primary outcomes:
measure: Time to lesion resolution
timeFrame: up to day 28
Secondary outcomes:
measure: Time to lesion resolution for participants with symptom onset less than or equal to 7 days before randomization
timeFrame: up to day 28
measure: Time to lesion resolution for participants with symptom onset greater than 7 days before randomization
timeFrame: up to day 28
measure: Number of participants with negative blood PCR results
timeFrame: day 14
measure: Number of participants with negative oropharyngeal swab PCR results
timeFrame: day 14
measure: Number of participants with negative lesion swab PCR results
timeFrame: day 14
measure: Mortality within the first 28 days post-randomization
timeFrame: up to day 28
measure: Number of days to participant death
timeFrame: up to day 28
measure: Frequency of solicited clinical symptoms
timeFrame: up to day 59
measure: Duration of solicited clinical symptoms
timeFrame: up to day 59
measure: Incidence of serious adverse events requiring drug discontinuation
timeFrame: up to day 14
measure: Incidence of adverse events requiring drug discontinuation
timeFrame: up to day 14
measure: Incidence of other adverse events
timeFrame: up to day 28
measure: Incidence of bacterial infections
timeFrame: up to day 28
Other outcomes:
Locations:
city: Kole
country: Congo, The Democratic Republic of the
facility: L'Hôpital Général de Référence de Kole
city: Tunda
country: Congo, The Democratic Republic of the
facility: L'Hôpital Général de Référence de Tunda
Study officials:
affiliation: Kinshasa University
name: Jean-Jacques Muyembe-Tamfum, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: