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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human cases of monkeypox confirmed by PCR | Laboratory-confirmed mpox infection is defined as determined by polymerase chain reaction assay (PCR), culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 5 days of inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viral genomic | Diagnostic Test | Evaluation of mpox viral genomic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions | symptoms' incidence in participants with mpox infection | Up to 90 days after the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Incidence of death | Up to 90 days after the inclusion |
| Hospitalizations | Incidence of hospitalization | Days 15, 30, 60, and 90 |
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Inclusion Criteria:
(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:
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Individuals who have risk factors for mpox infection in Brazil.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrique AR Fonseca, PhD | Contact | +5511968308958 | henrique.fonseca@einstein.br | |
| Diogo Moia, PharmD | Contact | diogo.moia@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Henrique Fonseca | Hospital Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário João de Barros Barreto | Recruiting | Belém | Pará | Brazil |
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| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Blood samples; Urine; oropharynx and Skin Lesions
| Untargeted Metabolomics | Diagnostic Test | Evaluation of metabolomics of the total plasma, oropharynx, and skin samples. |
|
| Untargeted metabolomics of total plasmas and skin lesion | Changes among visits of Immune-metabolomics responses related to symptoms' incidence | Days 15, 30, 60, and 90 |
| Viral genomic | Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil | Day 0 |
| Hospital Israelita Albert Einstein | Recruiting | São Paulo | São Paulo | Brazil |
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| Hospital Naval Marcílio Dias | Recruiting | Rio de Janeiro | Brazil |
|
| D018419 |
| Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |