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 - Extension Amendment
The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.
• 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
• 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
• Severe disease, defined as the presence of at least one of the following:
‣ Flat lesions (flat and soft lesions; no pustules or vesicles visible to the eye)
⁃ Pregnancy (due to risk of serious complication)
⁃ Suspected sickle cell disease
⁃ Severe clinical disease, defined as having at least 3 of the following:
• Lesion count greater than 250
∙ Fever for greater than 48 hours
∙ Hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg)
∙ Pallor
∙ Respiratory distress
∙ Altered mental status
∙ Extreme lethargy
∙ Painful oral lesions making oral intake difficult
∙ Difficulty peeing or pooping due to painful lesions
∙ Painful lesions on hands and feet
∙ Tachycardia (heart rate greater than 100 beats per minute)
∙ Diarrhea (greater than or equal to 3 liquid stools per 24 hours)