Tecovirimat for Treatment of Monkeypox Virus
Study Details
Study Description
Brief Summary
The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tecovirimat Tecovirimat capsules administered orally to participants for 14 days plus SOC. |
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)
Other Names:
|
| Placebo Comparator: Placebo Matching placebo capsules administered orally to participants for 14 days plus SOC. |
Drug: Placebo
Capsules to match tecovirimat
|
Outcome Measures
Primary Outcome Measures
- Time to lesion resolution [up to day 28]
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.
Secondary Outcome Measures
- Number of days to the first negative MPXV PCR test result [up to day 28]
Measured by blood PCR tests
- Mortality within the first 28 days post-randomization [up to day 28]
Number of deaths post-randomization
- Number of days to participant death [up to day 28]
Number of days post-randomization
- Frequency of solicited clinical symptoms [up to day 59]
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.
- Duration of solicited clinical symptoms [up to day 59]
Number of days
- Incidence of serious adverse events requiring drug discontinuation [up to day 14]
Number of SAEs
- Incidence of adverse events requiring drug discontinuation [up to day 14]
Number of AEs
- Incidence of other adverse events [up to day 28]
Number of AEs
- Incidence of bacterial infections [up to day 28]
Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.
Eligibility Criteria
Criteria
This study has no age restriction.
Inclusion Criteria:
-
Laboratory-confirmed monkeypox 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | L'Hôpital Général de Référence de Kole | Kole | Congo, The Democratic Republic of the | ||
| 2 | L'Hôpital Général de Référence de Tunda | Tunda | Congo, The Democratic Republic of the |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Investigators
- Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD PhD, Kinshasa University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PALM 007