Treatment of Monkeypox with Standard Care
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
This study looks at how people with confirmed monkeypox recover with standard care during outbreaks, while tracking their symptoms and allowing for check-ups if new lesions appear.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 2 sites (Kole and 1 other locations) |
| Trial ID | NCT06721585 on ClinicalTrials.gov |
What this trial studies
This observational extension of the PALM007 protocol aims to further characterize the clinical and natural history of mpox while providing standard of care (SOC) during ongoing outbreaks. Participants with laboratory-confirmed mpox will receive SOC until recovery, defined as the resolution of all lesions and a negative blood test for MPXV. The study allows for sick visits if new lesions develop after initial recovery. The administration of tecovirimat has been discontinued due to lack of observed efficacy compared to placebo.
Who should consider this trial
Good fit: Ideal candidates include individuals with laboratory-confirmed mpox infection who have at least one active lesion.
Not a fit: Patients with mild mpox symptoms or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of mpox and improve management strategies for affected patients.
How similar studies have performed: While previous studies have explored treatments for mpox, this extension focuses on standard care and the natural history of the disease, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
This study has no age restriction
Inclusion Criteria:
1. Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
2. Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
3. Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
4. Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
5. Severe disease, defined as the presence of at least one of the following:
1. Flat lesions (flat and soft lesions; no pustules or vesicles visible to the eye)
2. Pregnancy (due to risk of serious complication)
3. Suspected sickle cell disease
4. 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)
Exclusion Criteria:
1. Severe anemia, defined as hemoglobin less than 7 g/dL
2. Current or planned use of another investigational drug at any point during study participation
3. Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Where this trial is running
Kole and 1 other locations
- L'Hôpital Général de Référence de Kole — Kole, Congo, The Democratic Republic of the (Recruiting)
- L'Hôpital Général de Référence de Tunda — Tunda, Congo, The Democratic Republic of the (Recruiting)
Study contacts
- Principal investigator: Jean-Jacques Muyembe-Tamfum, MD PhD — Kinshasa University
- Study coordinator: Veronique Nussenblatt, MD ScM MHS
- Email: veronique.nussenblatt@nih.gov
- Phone: +1-240-812-2075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.