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

Status: Completed
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Democratic Republic of the Congo
L'Hôpital Général de Référence de Kole
Kole
L'Hôpital Général de Référence de Tunda
Tunda
Time Frame
Start Date: 2024-07-10
Completion Date: 2025-08-30
Participants
Target number of participants: 328
Treatments
Open-access tecovirimat plus SOC for mpox
Participants are provided SOC as well as open-access tecovirimat. Tecovirimat capsules are administered orally to participants for 14 days based on participant weight.~Closed to new participants in August 2024.
Standard of care for mpox
Participants are provided SOC for mpox.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

This content was sourced from clinicaltrials.gov