Tecovirimat for Treatment of Monkeypox Virus

Monkeypox Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559099
• Other study ID #: PALM 007
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2022
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: Veronique Nussenblatt, MD ScM MHS
• Phone: +1-240-812-2075
• Email: veronique.nussenblatt[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Monkeypox

Intervention

Drug:
• Tecovirimat Oral Capsule
200 mg capsules Number of capsules and frequency of dosage will be based on participant weight: =120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg) 40 to <120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg) 25 to <40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg) 13 to <25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg) 6 to <13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg) 3 to <6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg)
• Placebo
Capsules to match tecovirimat

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	L'Hôpital Général de Référence de Kole	Kole
Congo, The Democratic Republic of the	L'Hôpital Général de Référence de Tunda	Tunda

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to lesion resolution	Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.	up to day 28
Secondary	Time to lesion resolution for participants with symptom onset less than or equal to 7 days before randomization	Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.	up to day 28
Secondary	Time to lesion resolution for participants with symptom onset greater than 7 days before randomization	Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.	up to day 28
Secondary	Number of participants with negative blood PCR results	Proportion of participants with negative blood sample MPXV PCR results 14 days post-randomization	day 14
Secondary	Number of participants with negative oropharyngeal swab PCR results	Proportion of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization	day 14
Secondary	Number of participants with negative lesion swab PCR results	Proportion of participants with negative lesion swab MPXV PCR results 14 days post-randomization	day 14
Secondary	Mortality within the first 28 days post-randomization	Number of deaths post-randomization	up to day 28
Secondary	Number of days to participant death	Number of days post-randomization	up to day 28
Secondary	Frequency of solicited clinical symptoms	Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhea, anorexia, cough, lymphadenopathy, dysphagia, sore throat, muscle aches, fatigue/lack of energy, fever, chills, night sweats, headache, ocular lesions, eye pain, change in vision, buccal ulcers, nasal congestion, cough, joint pain, pain with urination, painful skin lesions, pruritic skin lesions.	up to day 59
Secondary	Duration of solicited clinical symptoms	Number of days	up to day 59
Secondary	Incidence of serious adverse events requiring drug discontinuation	Number of SAEs	up to day 14
Secondary	Incidence of adverse events requiring drug discontinuation	Number of AEs	up to day 14
Secondary	Incidence of other adverse events	Number of AEs	up to day 28
Secondary	Incidence of bacterial infections	Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.	up to day 28