Monkeypox, MPOX
Conditions
Brief summary
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.
Interventions
DIAGNOSTIC_TESTViral genomic
Evaluation of mpox viral genomic
DIAGNOSTIC_TESTUntargeted Metabolomics
Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.
Sponsors
Ministry of Health, Brazil
Hospital Israelita Albert Einstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥ 18 years with confirmed MPOX infection. (laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)
Exclusion criteria
* Inability to provide informed consent; * Patient who, judging by the study team, does not have a condition for decentralized follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions | Up to 90 days after the inclusion | symptoms' incidence in participants with mpox infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Up to 90 days after the inclusion | Incidence of death |
| Hospitalizations | Days 15, 30, 60, and 90 | Incidence of hospitalization |
| Untargeted metabolomics of total plasmas and skin lesion | Days 15, 30, 60, and 90 | Changes among visits of Immune-metabolomics responses related to symptoms' incidence |
| Viral genomic | Day 0 | Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil |
Countries
Brazil
Contacts
Primary ContactHenrique AR Fonseca, PhD
Backup ContactDiogo Moia, PharmD
Outcome results
None listed