NCT05559099.

Study name	PALM007
Methods	Study setting: Not stated Study design: randomized (1:1), placebo‐controlled trial Dates of recruitment: recruiting (29 September 2022) Eligibility criteria Inclusion criteria Laboratory‐confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening Mpox 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 enrolment 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 anaemia, defined as haemoglobin < 7 g/dL Current or planned use of another investigational drug at any point during study participation People who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study People who are unable to safely swallow oral medications, such as those who are at risk of aspiration Length of follow‐up: 28 days, long term assessment at 59 days Loss to follow‐up: not applicable, ongoing Adherence to assigned treatment: not applicable, ongoing
Participants	Number of participants: 450 Source of participants: not stated Age: any Sex: any Disease severity: not stated but must have at least one active, not yet scabbed, lesion Vaccination status: not stated Concurrent treatments: standard of care Pregnancy: not eligible to participate Comorbidities: not stated
Interventions	Intervention Therapeutic: tecovirimat Route of administration: oral capsule Dosage: 200 mg capsules Timing and frequency: 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: 1800 mg) 40 to < 120 kg: three capsules twice a day (total daily tecovirimat dose: 1200 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: half the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg) 3 to < 6 kg: one quarter of the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg) Duration of treatment: 14 days Duration of follow‐up: 28 days Control Type: identical placebo Route of administration: oral capsule Dosage: 200 mg Timing: every 12 hours Frequency: twice daily Duration of treatment: 14 days Duration of follow‐up: 28 days
Outcomes	Primary Time to lesion resolution (up to day 28) defined as the 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 Number of days to the first of 2 consecutive negative mpox test results (up to day 28) measured by daily blood PCR tests Mortality within the first 28 days post‐randomization Number of days to the first negative mpox PCR result (up to day 28) measured by daily blood PCR tests Number of days to participant death (up to day 28) Frequency of solicited clinical symptoms (up to day 59). Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhoea, 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) Incidence of serious adverse events requiring drug discontinuation (up to day 14) Incidence of adverse events requiring drug discontinuation (up to day 14) Incidence of other adverse events (up to day 28) Incidence of bacterial infections (up to day 28) Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.
Starting date	Registered 29 September 2022
Contact information
Notes	Authors: Principal investigator Jean‐Jacques Muyembe‐Tamfum, Kinshasa University 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 Publication date: ongoing, estimated completion date August 2024 Country: Democratic Republic of Congo Funding details: Sponsors: National Institute of Allergy and Infectious Diseases (NIAID), Institut National de Recherche Biomédicale, Kinshasa, République Démocratique du Congo CoI statement: not stated