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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
597
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)
Capsules to match tecovirimat
L'Hôpital Général de Référence de Kole
Kole, Democratic Republic of the Congo
L'Hôpital Général de Référence de Tunda
Tunda, Democratic Republic of the Congo
Time to Lesion Resolution
Number of days from randomization to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.
Time frame: Up to day 28
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.
Time frame: up to day 28
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.
Time frame: up to day 28
Number and Percentage of Participants With Negative Blood PCR Results
Percentage of participants with negative blood sample MPXV PCR results 14 days post-randomization, out of those positive at baseline
Time frame: day 14
Number and Percentage of Participants With Negative Oropharyngeal Swab PCR Results
Number and percentage of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization, out of those positive at baseline
Time frame: day 14
Number and Percentage of Participants With Negative Lesion Swab PCR Results
Number and and percentage of participants with negative lesion swab MPXV PCR results 14 days post-randomization, of those positive at baseline
Time frame: day 14
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Mortality Within the First 28 Days Post-randomization
Number of deaths post-randomization
Time frame: up to day 28
Incidence of Non-fatal Serious Adverse Events Requiring Permanent Drug Discontinuation
Number of participants with a non-fatal serious adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days)
Time frame: Up to day 14
Incidence of Non-fatal Adverse Events Requiring Permanent Drug Discontinuation
Number of participants with a non-fatal adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days)
Time frame: Up to day 14
Incidence of Adverse Events
Number of participants with an adverse event up to day 28
Time frame: up to day 28
Incidence of Bacterial Infection Adverse Events
Number of participants with a bacterial infection adverse event up to day 28
Time frame: up to day 28